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    Clinical Trial Results:
    Non-inferiority study between molecular imaging of dopamine transporters obtained by the [123I]FP-CIT marker in SPECT and the [18F]LBT-999 biomarker in PET in the differential diagnosis between Parkinson’s Disease and Essential Tremor (DATTEP)

    Summary
    EudraCT number
    		 2019-000247-27
    Trial protocol
    		 FR  
    Global end of trial date
    02 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2026
    First version publication date
    20 Jun 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ZX-2018-LBT999-DATTEP-3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GE HealthCare 
    Sponsor organisation address
    Pollards Wood, Nightingales Lane, Chalfont St Giles , Buckinghamshire, United Kingdom, HP8 4SP
    Public contact
    Victoria Haas, GE HealthCare, +33 6 29 86 53 56, victoria.haas@gehealthcare.com
    Scientific contact
    Victoria Haas, GE HealthCare, +33 6 29 86 53 56, victoria.haas@gehealthcare.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Feb 2026
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate non-inferiority of [18F]LBT-999 Positron Emission Tomography (PET) imaging compared with [123I]FP-CIT Single Photon Emission Computed Tomography (SPECT) imaging in visual analysis for the differential diagnosis between subjects with typical Parkinson’s disease (PD) compared with subjects with essential tremor (ET).
    Protection of trial subjects
    This study was conducted in full accordance with the Declaration of Helsinki, the Good Clinical Practice: Consolidated Guideline approved by the International Council for Harmonization (ICH), and any applicable national and local laws and regulations. Investigators were responsible for performing the study in accordance with the protocol and ICH E6-Good Clinical Practice (GCP), for collecting, recording, and reporting the data accurately and properly. Agreement of the investigator to conduct and administer this study in accordance with the protocol was documented in separate study agreements with the Sponsor and other forms as required by national authorities in the country where the study centre was located.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 156
    Worldwide total number of subjects
    156
    EEA total number of subjects
    156
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    63
    From 65 to 84 years
    93
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 15 National Clinical Research Network for Parkinson’s Disease and Movement Disorders (NS-Park) centres in France from 01 December 2021 to 02 August 2024.

    Pre-assignment
    Screening details
    		 A total of 156 subjects provided informed consent and were screened for this study, out of which 152 were enrolled and randomised in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    Expert panel for image analysis were blinded in this study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Parkinson’s Disease
    Arm description
    		 Subjects with Parkinson's disease received a single dose of investigational medicinal product (IMP) and comparator IMP on Visit 1. Subjects were then randomised to undergo [18F]LBT-999 PET imaging on Visit 1 followed by [123I]FP-CIT SPECT imaging on Visit 2 or undergo [123I]FP-CIT SPECT imaging on Visit 1 followed by [18F]LBT-999 PET imaging on Visit 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GEH300022 (18F) Injection
    Investigational medicinal product code
    Other name
    [18F]LBT-999
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a single dose of [18F]LBT-999 at 3 megabecquerels per kilogram (MBq/kg) ±10% in a maximum volume of 10 millilitre (mL).

    Investigational medicinal product name
    DaTSCAN™
    Investigational medicinal product code
    Other name
    [123I]FP-CIT
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a single dose of [123I]FP-CIT at 185 MBq ±10% in a maximum volume of 5mL.

    Arm title
    		 Essential Tremor
    Arm description
    		 Subjects with essential tremors received a single dose of IMP and comparator IMP on Visit 1. Subjects were then randomised to receive [18F]LBT-999 PET imaging on Visit 1 followed by [123I]FP-CIT SPECT imaging on Visit 2 or undergo [123I]FP-CIT SPECT imaging on Visit 1 followed by [18F]LBT-999 PET imaging on Visit 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GEH300022 (18F) Injection
    Investigational medicinal product code
    Other name
    [18F]LBT-999
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a single dose of [18F]LBT-999 at 3 MBq/kg ±10% in a maximum volume of 10 mL.

    Investigational medicinal product name
    DaTSCAN™
    Investigational medicinal product code
    Other name
    [123I]FP-CIT
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a single dose of [123I]FP-CIT at 185 MBq ±10% in a maximum volume of 5mL.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Only the expert panel for image analysis were blinded in this study. Investigators, staff at the investigating centres, and the subjects taking part in the study were not blinded.
    Number of subjects in period 1
    		Parkinson’s Disease Essential Tremor
    Started
    77
    79
    Safety Population (SAF)
    71
    74
    Full Analysis Set (FAS)
    70
    72
    Completed
    69
    72
    Not completed
    8
    7
         Other
    3
    3
         Adverse event
    1
    -
         Screen failure
    1
    3
         Withdrawal of consent
    1
    1
         Withdrawal by subject
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Parkinson’s Disease
    Reporting group description
    		 Subjects with Parkinson's disease received a single dose of investigational medicinal product (IMP) and comparator IMP on Visit 1. Subjects were then randomised to undergo [18F]LBT-999 PET imaging on Visit 1 followed by [123I]FP-CIT SPECT imaging on Visit 2 or undergo [123I]FP-CIT SPECT imaging on Visit 1 followed by [18F]LBT-999 PET imaging on Visit 2.

    Reporting group title
    Essential Tremor
    Reporting group description
    		 Subjects with essential tremors received a single dose of IMP and comparator IMP on Visit 1. Subjects were then randomised to receive [18F]LBT-999 PET imaging on Visit 1 followed by [123I]FP-CIT SPECT imaging on Visit 2 or undergo [123I]FP-CIT SPECT imaging on Visit 1 followed by [18F]LBT-999 PET imaging on Visit 2.

    Reporting group values
    		 Parkinson’s Disease Essential Tremor Total
    Number of subjects
    		 77 79 156
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 40 23 63
        From 65-84 years
    		 37 56 93
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.5 ( 9.4 ) 65.9 ( 10.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 26 32 58
        Male
    		 51 47 98

    End points

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    End points reporting groups
    Reporting group title
    Parkinson’s Disease
    Reporting group description
    		 Subjects with Parkinson's disease received a single dose of investigational medicinal product (IMP) and comparator IMP on Visit 1. Subjects were then randomised to undergo [18F]LBT-999 PET imaging on Visit 1 followed by [123I]FP-CIT SPECT imaging on Visit 2 or undergo [123I]FP-CIT SPECT imaging on Visit 1 followed by [18F]LBT-999 PET imaging on Visit 2.

    Reporting group title
    Essential Tremor
    Reporting group description
    		 Subjects with essential tremors received a single dose of IMP and comparator IMP on Visit 1. Subjects were then randomised to receive [18F]LBT-999 PET imaging on Visit 1 followed by [123I]FP-CIT SPECT imaging on Visit 2 or undergo [123I]FP-CIT SPECT imaging on Visit 1 followed by [18F]LBT-999 PET imaging on Visit 2.

    Subject analysis set title
    PET scan
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects who underwent a PET scan either at Visit 1 or Visit 2.

    Subject analysis set title
    SPECT scan
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects who underwent a SPECT scan at Visit 1 or Visit 2.

    Primary: Proportion of Subjects With Parkinson’s Disease Whose Images Were Sensitive (Interpreted as Pathological)

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    End point title
    		 Proportion of Subjects With Parkinson’s Disease Whose Images Were Sensitive (Interpreted as Pathological)
    End point description
    Sensitivity was defined as proportion of subjects with PD whose images were interpreted as pathological. Independent blinded image evaluation of PET and SPEC images was conducted by 5 expert readers in France and Switzerland. For the initial assessment, readers were blinded to subject sex and age to prevent bias (i.e., without demographic data). In a subsequent confirmatory assessment, readers re-evaluated the images with access to subject sex, age and their original conclusion (i.e., with demographic data). In this endpoint, proportion of subjects with sensitivity, when assed with demographic data and when assessed without demographic data has been reported. Analysis was performed on the FAS, which included all subjects who signed informed consent form with both [18F]LBT-999 PET and [123I]FP-CIT SPECT scans performed and interpretable. Here, 'number of subjects analysed' = subjects with evaluable data for this endpoint.
    End point type
    Primary
    End point timeframe
    At Visit 1 (anytime between Day 7 and Day 45) and Visit 2 (anytime between Day 14 and Day 52)
    End point values
    		 PET scan SPECT scan
    Number of subjects analysed
    70
    70
    Units: proportion of subjects
    number (confidence interval 95%)
        Without Demographic Data
    0.943 (0.868 to 0.982)
    1.000 (0.958 to 1.000)
        With Demographic Data
    0.943 (0.868 to 0.982)
    1.000 (0.958 to 1.000)
    Statistical analysis title
    		 PET vs SPECT (Without Demographic Data)
    Comparison groups
    PET scan v SPECT scan
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0148
    Method
    		 Restricted maximum likelihood estimation
    Parameter type
    		 Difference Observed
    Point estimate
    -0.057
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -0.141
         upper limit
    		 -
    Statistical analysis title
    		 PET vs SPECT (With Demographic Data)
    Comparison groups
    PET scan v SPECT scan
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0148
    Method
    		 Restricted maximum likelihood estimation
    Parameter type
    		 Difference Observed
    Point estimate
    -0.057
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -0.141
         upper limit
    		 -

    Primary: Proportion of Subjects With Essential Tremor Whose Images Were Specific (Interpreted as Normal)

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    End point title
    		 Proportion of Subjects With Essential Tremor Whose Images Were Specific (Interpreted as Normal)
    End point description
    Specificity was defined as proportion of subjects with ET whose images were interpreted as normal. Independent blinded image evaluation of PET and SPEC images was conducted by 5 expert readers in France. For the initial assessment, readers were blinded to subject sex and age to prevent bias (i.e., without demographic data). In a subsequent confirmatory assessment, readers re-evaluated the images with access to subject sex, age and their original conclusion (i.e., with demographic data). In this endpoint, proportion of subjects with specificity, when assed with demographic data and when assessed without demographic data has been reported. Analysis was performed on the FAS, which included all subjects who signed informed consent form with both [18F]LBT-999 PET and [123I]FP-CIT SPECT scans performed and interpretable. Here, 'number of subjects analysed' = subjects with evaluable data for this endpoint.
    End point type
    Primary
    End point timeframe
    At Visit 1 (anytime between Day 7 and Day 45) and Visit 2 (anytime between Day 14 and Day 52)
    End point values
    		 PET scan SPECT scan
    Number of subjects analysed
    70
    70
    Units: proportion of subjects
    number (confidence interval 95%)
        Without Demographic Data
    1.000 (0.959 to 1.000)
    0.625 (0.509 to 0.731)
        With Demographic Data
    1.000 (0.959 to 1.000)
    0.611 (0.495 to 0.718)
    Statistical analysis title
    		 PET vs SPECT (Without Demographic Data)
    Comparison groups
    PET scan v SPECT scan
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0001
    Method
    		 Restricted maximum likelihood estimation
    Parameter type
    		 Difference Observed
    Point estimate
    0.375
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 0.221
         upper limit
    		 -
    Statistical analysis title
    		 PET vs SPECT (With Demographic Data)
    Comparison groups
    PET scan v SPECT scan
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0001
    Method
    		 Restricted maximum likelihood estimation
    Parameter type
    		 Difference Observed
    Point estimate
    0.389
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 0.233
         upper limit
    		 -

    Secondary: Threshold of Specific Binding Ratio (SBR) and Putaminal Index

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    End point title
    		 Threshold of Specific Binding Ratio (SBR) and Putaminal Index
    End point description
    Putaminal Index is a measure specific to DaTsoft-3D. It accounts for the minimum uptake in the left/right posterior putamina, striatal contrast and participant age. The discrimination thresholds for the SBR between the right and left putamen, right and left posterior part of the putamen and the putaminal index (Parkinson index), determined using the minimum SBR values are reported. Threshold with Wald-type 2-sided 95% confidence interval (delta method approximation) was determined by maximum correct classification rate and maximum Younden index. Analysis was performed on the FAS. Here, 'number of subjects analysed' = subjects with available data for this endpoint. Threshold of the minimum value of the binding potential between right and left putamen, threshold of the minimum value of the binding potential between right and left posterior of putamen and threshold of the Putaminal Index (Parkinson Index) is reported for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 53
    End point values
    		 PET scan
    Number of subjects analysed
    59
    Units: Ratio
    number (confidence interval 95%)
        Right and left putamen
    2.33 (1.98 to 2.68)
        Right and left posterior part of putamen
    1.71 (1.21 to 2.21)
        Putaminal Index (Parkinson Index)
    0.88 (0.16 to 1.60)
    No statistical analyses for this end point

    Secondary: Subject Comfort as Assessed Using a Visual Analog Scale (VAS)

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    End point title
    		 Subject Comfort as Assessed Using a Visual Analog Scale (VAS)
    End point description
    Subject comfort was measured using a VAS for each type of scan ([18F]LBT-999 PET or [123I]FP-CIT SPECT). VAS scale ranged from 0 to 10, where 0 signifies very uncomfortable to 10 being very comfortable. Analysis was performed on FAS population which included all subjects who signed informed consent form with both [18F]LBT-999 PET and [123I]FP-CIT SPECT scans performed and interpretable. Here, 'number of subjects analysed' = subjects in the FAS population without whole-body dosimetry participation.
    End point type
    Secondary
    End point timeframe
    At Visit 1 (anytime between Day 7 and Day 45) and Visit 2 (anytime between Day 14 and Day 52)
    End point values
    		 PET scan SPECT scan
    Number of subjects analysed
    132
    132
    Units: score on a scale
        arithmetic mean (standard deviation)
    8.9 ( 1.5 )
    8.4 ( 1.5 )
    No statistical analyses for this end point

    Secondary: Diagnostic Confidence as Assessed Using Image Quality

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    End point title
    		 Diagnostic Confidence as Assessed Using Image Quality
    End point description
    Diagnostic confidence in the interpretation of radiopharmaceutical IMP binding for the caudate nuclei and putamen of each subject for each type of scan ([18F]LBT-999 PET or [123I]FP-CIT SPECT) was reported. This confidence was assessed for each reviewer using criteria scales for image quality and interpretation confidence. Image quality was assessed as "Not Readable" (artifacts, low contrast, low signal level or poor focus seriously compromise image interpretation) , "Readable but sub-optimal" (artifacts or suboptimal signal to noise ratio may somewhat reduce confidence of interpretation) and "Readable" (artifacts, if evident, present no obstacle to interpretation). Analysis was performed on the FAS, which included all subjects who signed informed consent form with both [18F]LBT-999 PET and [123I]FP-CIT SPECT scans performed and interpretable. The data reported applies for analyses conducted both with and without demographic data.
    End point type
    Secondary
    End point timeframe
    At Visit 1 (anytime between Day 7 and Day 45) and Visit 2 (anytime between Day 14 and Day 52)
    End point values
    		 PET scan SPECT scan
    Number of subjects analysed
    142
    142
    Units: subjects
        Reader 1: Not Readable
    0
    2
        Reader 1: Readable but Sub-Optimal
    9
    89
        Reader 1: Readable
    133
    51
        Reader 2: Not Readable
    0
    0
        Reader 2: Readable but Sub-Optimal
    3
    21
        Reader 2: Readable
    139
    121
        Reader 3: Not Readable
    0
    0
        Reader 3: Readable but Sub-Optimal
    0
    34
        Reader 3: Readable
    142
    108
        Reader 4: Not Readable
    0
    8
        Reader 4: Readable but Sub-Optimal
    0
    62
        Reader 4: Readable
    142
    72
        Reader 5: Not Readable
    0
    0
        Reader 5: Readable but Sub-Optimal
    0
    30
        Reader 5: Readable
    142
    112
    No statistical analyses for this end point

    Secondary: Diagnostic Confidence as Assessed Using Interpretation Confidence

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    End point title
    		 Diagnostic Confidence as Assessed Using Interpretation Confidence
    End point description
    Diagnostic confidence in the interpretation of radiopharmaceutical IMP binding for the caudate nuclei and putamen of each subject for each type of scan ([18F]LBT-999 PET or [123I]FP-CIT SPECT) was reported. This confidence was assessed for each reviewer using criteria scales for image quality and interpretation confidence. In this endpoint, interpretation confidence, when assed with demographic data and when assessed without demographic data has been reported. Interpretation confidence was assessed as "Low" (no or limited capacity to assess the normal or abnormal), "Moderate" (normality or abnormality can be likely established) and "Strong" (normality or abnormality can be well established). Analysis was performed on the FAS, which included all subjects who signed informed consent form with both [18F]LBT-999 PET and [123I]FP-CIT SPECT scans performed and interpretable.
    End point type
    Secondary
    End point timeframe
    At Visit 1 (anytime between Day 7 and Day 45) and Visit 2 (anytime between Day 14 and Day 52)
    End point values
    		 PET scan SPECT scan
    Number of subjects analysed
    142
    142
    Units: subjects
        Reader 1-Without Demo data: Low
    0
    4
        Reader 1-Without Demo data: Moderate
    8
    53
        Reader 1-Without Demo data: Strong
    134
    83
        Reader 2-Without Demo data: Low
    12
    24
        Reader 2-Without Demo data: Moderate
    24
    32
        Reader 2-Without Demo data: Strong
    106
    86
        Reader 3-Without Demo data: Low
    0
    3
        Reader 3-Without Demo data: Moderate
    7
    37
        Reader 3-Without Demo data: Strong
    135
    102
        Reader 4-Without Demo data: Low
    1
    31
        Reader 4-Without Demo data: Moderate
    1
    49
        Reader 4-Without Demo data: Strong
    140
    54
        Reader 5-Without Demo data: Low
    1
    4
        Reader 5-Without Demo data: Moderate
    3
    33
        Reader 5-Without Demo data: Strong
    138
    105
        Reader 1-With Demo data: Low
    1
    4
        Reader 1-With Demo data: Moderate
    5
    42
        Reader 1-With Demo data: Strong
    136
    94
        Reader 2-With Demo data: Low
    6
    20
        Reader 2-With Demo data: Moderate
    21
    31
        Reader 2-With Demo data: Strong
    115
    91
        Reader 3-With Demo data: Low
    0
    3
        Reader 3-With Demo data: Moderate
    7
    37
        Reader 3-With Demo data: Strong
    135
    102
        Reader 4-With Demo data: Low
    1
    29
        Reader 4-With Demo data: Moderate
    1
    49
        Reader 4-With Demo data: Strong
    140
    56
        Reader 5-With Demo data: Low
    1
    8
        Reader 5-With Demo data: Moderate
    3
    30
        Reader 5-With Demo data: Strong
    138
    104
    No statistical analyses for this end point

    Secondary: Sensitivity and Specificity of Diagnosis by the Specific Binding Ratio of Different Brain Areas

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    End point title
    		 Sensitivity and Specificity of Diagnosis by the Specific Binding Ratio of Different Brain Areas
    End point description
    The quantitative performance of [18F]LBT-999 PET and [123I]FP-CIT SPECT was evaluated by the sensitivity and specificity of each imaging method for classifying images as normal (consistent with ET) or pathological (consistent with PD), based on the discrimination thresholds for the SBR determined for the putamen, posterior part of the putamen and putaminal index (Parkinson index). Analysis was performed on the FAS, which included all subjects who signed informed consent form with both [18F]LBT-999 PET and [123I]FP-CIT SPECT scans performed and interpretable. Here, "n" = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    At Visit 1 (anytime between Day 7 and Day 45) and Visit 2 (anytime between Day 14 and Day 52)
    End point values
    		 PET scan SPECT scan
    Number of subjects analysed
    142
    142
    Units: ratio
    number (confidence interval 95%)
        Putamen: Sensitivity (n=70,70)
    0.829 (0.727 to 0.904)
    0.929 (0.849 to 0.973)
        Putamen: Specificity (n=72,72)
    0.944 (0.871 to 0.982)
    0.972 (0.911 to 0.995)
        Posterior Part of Putamen: Sensitivity (n=70,70)
    0.900 (0.812 to 0.955)
    0.943 (0.868 to 0.982)
        Posterior Part of Putamen: Specificity (n=72,72)
    1.000 (0.959 to 1.000)
    0.986 (0.933 to 0.999)
        Putaminal Index: Sensitivity (n=70,70)
    0.871 (0.777 to 0.935)
    0.943 (0.868 to 0.982)
        Putaminal Index: Specificity (n=72,72)
    1.000 (0.959 to 1.000)
    0.986 (0.933 to 0.999)
    No statistical analyses for this end point

    Secondary: Coefficient of Variation (CV) of the Specific binding ratio

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    End point title
    		 Coefficient of Variation (CV) of the Specific binding ratio
    End point description
    The CV of the SBR measurements (putamen and posterior part of the putamen) and putaminal index (Parkinson index) for both [18F]LBT-999 PET and [123I]FP-CIT SPECT was utilised as a measure of precision. The CV was calculated as the ratio between standard deviation (SD) and the mean. Analysis was performed on the FAS, which included all subjects who signed informed consent form with both [18F]LBT-999 PET and [123I]FP-CIT SPECT scans performed and interpretable.
    End point type
    Secondary
    End point timeframe
    At Visit 1 (anytime between Day 7 and Day 45) and Visit 2 (anytime between Day 14 and Day 52)
    End point values
    		 PET scan SPECT scan
    Number of subjects analysed
    142
    142
    Units: ratio
    number (not applicable)
        Putamen
    52.5
    66.5
        Posterior Part of the Putamen
    73.7
    85.5
        Putaminal Index (Parkinson Index)
    88.3
    98.9
    No statistical analyses for this end point

    Secondary: Number of Subjects With any Adverse Events (AE), Treatment-emergent AE (TEAE), Serious TEAE and Severe TEAE

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    End point title
    		 Number of Subjects With any Adverse Events (AE), Treatment-emergent AE (TEAE), Serious TEAE and Severe TEAE
    End point description
    An AE was defined as any harmful occurrence in a person who was the subject of research involving humans, whether or not the occurrence was related to the research or to the product to which the research related. TEAE was defined as any AE that occurred during treatment which was absent before treatment, or worsened compared to the pre-treatment state. An SAE was defined as any AE that: resulted in death; was life-threatening; required inpatient hospitalisation or prolongation of existing hospitalisation; resulted in persistent or long-lasting disability or incapacity; was a congenital anomaly or malformation; was another significant medical event. Severe TEAE was an event that prevented normal everyday activities. Analysis was performed on SAF. The SAF included all subjects who signed an informed consent form, were randomised and had at least 1 scan performed.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 53
    End point values
    		 PET scan SPECT scan
    Number of subjects analysed
    144
    145
    Units: subjects
        Any AE
    7
    5
        TEAE
    7
    5
        Serious TEAE
    0
    0
        Severe TEAE
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With any Adverse AE, TEAE, Serious TEAE and Severe TEAE

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    End point title
    		 Percentage of Subjects With any Adverse AE, TEAE, Serious TEAE and Severe TEAE
    End point description
    An AE was defined as any harmful occurrence in a person who was the subject of research involving humans, whether or not the occurrence was related to the research or to the product to which the research related. TEAE was defined as any AE that occurred during treatment which was absent before treatment, or worsened compared to the pre-treatment state. An SAE was defined as any AE that: resulted in death; was life-threatening; required inpatient hospitalisation or prolongation of existing hospitalisation; resulted in persistent or long-lasting disability or incapacity; was a congenital anomaly or malformation; was another significant medical event. Severe TEAE was an event that prevented normal everyday activities. Analysis was performed on SAF. The SAF included all subjects who signed an informed consent form, were randomised and had at least 1 scan performed.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 53
    End point values
    		 PET scan SPECT scan
    Number of subjects analysed
    142
    142
    Units: percentage of subjects
    number (not applicable)
        Any AE
    7.6
    4.9
        TEAE
    7.6
    4.9
        Serious TEAE
    0
    0
        Severe TEAE
    0
    0
    No statistical analyses for this end point

    Secondary: Subject Dosimetry by Organ after PET Scan

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    End point title
    		 Subject Dosimetry by Organ after PET Scan
    End point description
    Internal radiation dosimetry measurements (absorbed organ dose and effective dose) for [18F]LBT-999 PET were summarised by organ for subjects who took part in the whole-body dosimetry. Analysis was performed on randomised population (RAN), which included all subjects who signed an informed consent form and were randomised. Here, 'number of subjects analysed' = subjects with available data for this endpoint. Absorbed dose data (per unit administered activity) was reported for brain, heart, kidney, liver, lungs and red bone marrow, and effective dose was reported for the whole body. Unit of measure for "Effective dose - Whole Body" category is millisieverts per megabecquerel (mSv/MBq).
    End point type
    Secondary
    End point timeframe
    At Visit 1 (anytime between Day 7 and Day 45) and Visit 2 (anytime between Day 14 and Day 52)
    End point values
    		 PET scan
    Number of subjects analysed
    10
    Units: milligray by megabecquerel (mGy/MBq)
    arithmetic mean (standard deviation)
        Absorbed Dose - Brain
    0.0143 ( 0.0018 )
        Absorbed Dose - Heart
    0.0174 ( 0.0022 )
        Absorbed Dose - Kidney
    0.0210 ( 0.0028 )
        Absorbed Dose - Liver
    0.0147 ( 0.0016 )
        Absorbed Dose - Lungs
    0.0185 ( 0.0019 )
        Absorbed Dose - Red Bone Marrow
    0.0241 ( 0.0034 )
        Effective Dose - Whole-Body
    0.0178 ( 0.0028 )
    No statistical analyses for this end point

    Secondary: Caregiver Dosimetry Equivalent Doses to Skin and Tissues

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    End point title
    		 Caregiver Dosimetry Equivalent Doses to Skin and Tissues
    End point description
    The dosimetry equivalent doses to the skin and tissue of caregivers are presented by scan type and task (preparation and injection). Two dosimetry values were collected: the personal dose equivalent at a depth of 0.07 millimetre (mm) (Hp (0.07)) (operational dose for individual monitoring to assess the dose to skin, hands and feet) and the personal dose equivalent at a depth of 10 mm (Hp (10)) (operational dose for individual monitoring to assess the effective dose). Analysis was performed on RAN, which included all subjects who signed an informed consent form and were randomised. Here, 'number of subjects analysed' = subjects with available data for this endpoint and 'n' = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    At Visit 1 (anytime between Day 7 and Day 45) and Visit 2 (anytime between Day 14 and Day 52)
    End point values
    		 PET scan SPECT scan
    Number of subjects analysed
    24
    24
    Units: mGy/MBq
    arithmetic mean (standard deviation)
        Operational: Hp (0.07) - Preparation (n=24,24)
    0.1281 ( 0.1063 )
    0.0278 ( 0.0314 )
        Operational: Hp (0.07) - Injection (n=23,24)
    0.0804 ( 0.0669 )
    0.0745 ( 0.0661 )
        Operational: Hp (10) - Preparation (n=24,24)
    0.1191 ( 0.1078 )
    0.0243 ( 0.0265 )
        Operational: Hp (10) - Injection (n=23,24)
    0.0586 ( 0.0510 )
    0.0514 ( 0.0422 )
        Extremity: Hp (0.07) - Preparation (n=23,22)
    139.9 ( 67.0 )
    21.4 ( 19.3 )
        Extremity: Hp (0.07) - Injection (n=13,22)
    25.2 ( 5.3 )
    7.2 ( 4.6 )
    No statistical analyses for this end point

    Secondary: Correlation Coefficient between Total Score of MDS-UPDRS Part III and Specific Binding Ratio and Parkinson Index

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    End point title
    		 Correlation Coefficient between Total Score of MDS-UPDRS Part III and Specific Binding Ratio and Parkinson Index
    End point description
    Correlation coefficients between total motor Movement Disorder Society – Sponsored Revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score and the minimum value of the SBR between the right and left putamen, the minimum value of the SBR between the right and left posterior part of the putamen and putaminal index (Parkinson Index) are reported for PD participants in this endpoint. The correlation coefficient and its 95% CI between MDS-UPDRS Part III motor score and SBR were calculated for each scan type. The two CIs were obtained and then compared. Analysis was performed on the FAS, which included all subjects who signed informed consent form with both [18F]LBT-999 PET and [123I]FP-CIT SPECT scans performed and interpretable. Here, 'number of subjects analysed' = subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Visit 1 (anytime between Day 7 and Day 45) and Visit 2 (anytime between Day 14 and Day 52)
    End point values
    		 PET scan SPECT scan
    Number of subjects analysed
    69
    69
    Units: Spearman correlation coefficient
    number (confidence interval 95%)
        Putamen
    -0.276 (-0.482 to -0.042)
    -0.133 (-0.359 to 0.107)
        Posterior Part of the Putamen
    -0.116 (-0.343 to 0.124)
    -0.09 (-0.32 to 0.149)
        Putaminal Index (Parkinson Index)
    -0.102 (-0.331 to 0.138)
    -0.093 (-0.323 to 0.147)
    No statistical analyses for this end point

    Secondary: Number of Subjects Whose Images Were Correctly Diagnosed

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    End point title
    		 Number of Subjects Whose Images Were Correctly Diagnosed
    End point description
    The accuracy of each imaging method for classifying images as normal (consistent with ET) or pathological (consistent with PD) was determined based on blinded visual interpretations performed by 5 independent nuclear medicine reviewers (majority read). For the initial assessment, readers were blinded to subject sex and age to prevent bias (i.e., without demographic data). In a subsequent confirmatory assessment, readers re-evaluated the images with access to subject sex, age and their original conclusion (i.e., with demographic data). Analysis was performed on the FAS, which included all subjects who signed informed consent form with both [18F]LBT-999 PET and [123I]FP-CIT SPECT scans performed and interpretable.
    End point type
    Secondary
    End point timeframe
    At Visit 1 (anytime between Day 7 and Day 45) and Visit 2 (anytime between Day 14 and Day 52)
    End point values
    		 PET scan SPECT scan
    Number of subjects analysed
    142
    142
    Units: subjects
        Without Demographic Data
    138
    115
        With Demographic Data
    138
    114
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Whose Images Were Correctly Diagnosed

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    End point title
    		 Percentage of Subjects Whose Images Were Correctly Diagnosed
    End point description
    The accuracy of each imaging method for classifying images as normal (consistent with ET) or pathological (consistent with PD) was determined based on blinded visual interpretations performed by 5 independent nuclear medicine reviewers (majority read). For the initial assessment, readers were blinded to subject sex and age to prevent bias (i.e., without demographic data). In a subsequent confirmatory assessment, readers re-evaluated the images with access to subject sex, age and their original conclusion (i.e., with demographic data). Analysis was performed on the FAS, which included all subjects who signed informed consent form with both [18F]LBT-999 PET and [123I]FP-CIT SPECT scans performed and interpretable.
    End point type
    Secondary
    End point timeframe
    At Visit 1 (anytime between Day 7 and Day 45) and Visit 2 (anytime between Day 14 and Day 52)
    End point values
    		 PET scan SPECT scan
    Number of subjects analysed
    142
    142
    Units: percentage of subjects
    number (confidence interval 95%)
        Without Demographic Da
    0.972 (0.933 to 0.991)
    0.810 (0.739 to 0.868)
        With Demographic Data
    0.972 (0.933 to 0.991)
    0.803 (0.731 to 0.862)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Day 53
    Adverse event reporting additional description
    Reported adverse events (AE) are treatment emergent adverse events (TEAEs). Analysis was performed on SAF. The SAF included all subjects who signed an informed consent form, were randomised and had at least 1 scan performed.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Parkinson’s Disease
    Reporting group description
    		 Subjects with Parkinson's disease received a single dose of IMP and comparator IMP on Visit 1. Subjects were then randomised to undergo [18F]LBT-999 PET imaging on Visit 1 followed by [123I]FP-CIT SPECT imaging on Visit 2 or undergo [123I]FP-CIT SPECT imaging on Visit 1 followed by [18F]LBT-999 PET imaging on Visit 2.

    Reporting group title
    Essential Tremor
    Reporting group description
    		 Subjects with essential tremors received a single dose of IMP and comparator IMP on Visit 1. Subjects were then randomised to undergo [18F]LBT-999 PET imaging on Visit 1 followed by [123I]FP-CIT SPECT imaging on Visit 2 or undergo [123I]FP-CIT SPECT imaging on Visit 1 followed by [18F]LBT-999 PET imaging on Visit 2.

    Serious adverse events
    		 Parkinson’s Disease Essential Tremor
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 74 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Parkinson’s Disease Essential Tremor
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 71 (11.27%)
    3 / 74 (4.05%)
    Surgical and medical procedures
    Dental operation
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    4 / 71 (5.63%)
    2 / 74 (2.70%)
         occurrences all number
    4
    2
    Taste disorder
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Injection site paraesthesia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences all number
    2
    0
    Dry mouth
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Sep 2021
    Protocol was amended to implement the following changes: • Addition of an IMP manufacturing site in Toulouse. • Change of principal investigator in Marseille. • Change of a member on the monitoring committee.
    10 Feb 2022
    Protocol was amended to implement the following changes: • Addition of 2 participating sites. • Update of the list of investigators. • Addition of a secondary objective and an associated endpoint for the MDS-UPDRS Part III scale. • Addition of a non-inclusion criterion. • Addition of the Tremor Research Group Essential Tremor Rating Assessment Scale. • Addition of the Temperament and Character Inventory (TCI) questionnaire. • Addition of an exploratory secondary objective and an exploratory associated endpoint for the TCI. • Further details were provided for vital signs data collection. The following update was made to text in the protocol: The subject's vital signs (blood pressure, heart rate, respiratory rate, body temperature) are measured after approximately 3 to 5 minutes in the supine position,10 minutes ±5 minutes before injection and 25 minutes ±5 minutes after injection.
    09 Jun 2022
    Protocol was amended to implement the following changes: • Change of a member of the safety committee. • Addition of an investigational medicinal product manufacturing site in Orsay. • Exploratory objective/endpoint updated to ancillary objective.
    19 Sep 2022
    Protocol was amended to implement the following changes: • Addition of investigating centre. • Change of principal investigator for Centre Eugene Marquis (Nuclear Medicine Department).
    02 Dec 2022
    Protocol was amended to implement the following changes: • Change of a member of the Safety Committee. • Addition of an investigating centre. • Removal of annexes and creation of independent documents. • Clarification of the number of subjects for image reviews. • Addition of co-investigators.
    21 Apr 2023
    Protocol was amended to implement the following changes: • Increase in the total number of subjects to be included. • Modification of statistical analysis for the co-primary endpoints. • Clarification of secondary evaluation criteria. • Addition of a composite secondary objective. • Clarification of 2 eligibility criteria. • Addition of an LBT manufacturing centre in Strasbourg. • Addition of 3 investigating centres in Lyon, Strasbourg and Dijon. • Addition of 2 new co-investigators at the Bordeaux centre. • Removal of 1 co-investigator at the Rennes centre. • Modification of statistical analyses for secondary evaluation criteria. • Clarification of the analysis of the ancillary study. • Clarification of the quantification method. • Accuracy of the visit window for study data tabulation model (STDM). • Other minor changes to the text of the protocol.
    11 Oct 2023
    Protocol was amended to implement the following changes: • Addition of 1 investigating site (Avicenne Hospital Centre). • Extension of study duration (recruitment period and end of study). • Investigator list update.
    17 Apr 2024
    Protocol was amended to implement the following changes: • Modification of inclusion criteria. • Modification of main investigator. • Updated study project team.
    21 Jun 2024
    Protocol was amended to implement the following changes: • Change of study sponsor from Zionexa to GE HealthCare Limited.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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