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    Clinical Trial Results:
    Amyloid imaging in late life depression

    Summary
    EudraCT number
    		 2009-018064-95
    Trial protocol
    		 BE  
    Global end of trial date
    13 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jan 2026
    First version publication date
    24 Jan 2026
    Other versions
    Summary report(s)
    		 published_data

    Trial information

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    Trial identification
    Sponsor protocol code
    S52151
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    KU Leuven
    Sponsor organisation address
    Oude Markt 13, Leuven, Belgium, 3000
    Public contact
    Mathieu Vandenbulcke, KU Leuven, 32 16346790, mathieu.vandenbulcke@uzleuven.be
    Scientific contact
    Mathieu Vandenbulcke, KU Leuven, 32 16346790, mathieu.vandenbulcke@uzleuven.be
    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
    03 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate if late depression is associated with increased cerebral amyloid deposition, we will carry out a voxel-based comparison of the 18F-flutemetamol images between patients with life depression and healthy controls using a two-sample t test in SPM05.
    Protection of trial subjects
    The protocol and all relevant documentation were approved by the Independent Ethics Committees at each participating site (University of Leuven and UPC Kortenberg before initiation. Written informed consent was obtained from all enrolled participants prior to any study procedure, including administration of [¹⁸F]‑flutemetamol. The trial was conducted in accordance with the principles of Good Clinical Practice, the Declaration of Helsinki, and applicable EU and Belgian regulations. Radiation exposure was minimized and monitored, with injection procedures standardized and supervised by qualified nuclear medicine physicians. Adverse events were actively monitored throughout the study and reviewed by the safety monitoring team to ensure participant well‑being.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2009
    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
    Belgium: 108
    Worldwide total number of subjects
    108
    EEA total number of subjects
    108
    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)
    10
    From 65 to 84 years
    92
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 2009-2014, 55 patients >55 yrs with major depressive disorder (DSM-IV) were recruited consecutively from UPC-KU Leuven, Belgium and 53 age- and gender-matched healthy controls were recruited locally via database and newspaper advertisement. 46 controls were from a prior study (PMID:27226443) and stratified by APOE ε4 status.

    Pre-assignment
    Screening details
    		 Patients met DSM-IV criteria for major depressive disorder, age >55, without other major psychiatric or neurological illness. Controls had no depression or cognitive impairment, confirmed by clinical and neuropsychological assessment. APOE genotyping and MMSE (>26) were used for subgroup stratification.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding was implemented. Group allocation (depressed vs. control) was known during analysis

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Late life depression
    Arm description
    		 Patients over age 55 with major depressive disorder.
    Arm type
    		 Observational patient group

    Investigational medicinal product name
    NoIMP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Not mentioned
    Dosage and administration details
    Not applicable – no investigational medicinal product administered. 18F-flutemetamol radiotracer was used only for standard PET imaging procedures

    Arm title
    		 Control group
    Arm description
    		 Age- and gender-matched healthy controls with no history of depression or cognitive impairment.
    Arm type
    		 Observational control group

    Investigational medicinal product name
    NoIMP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Not mentioned
    Dosage and administration details
    Not applicable – no investigational medicinal product administered. 18F-flutemetamol radiotracer was used only for standard PET imaging procedures

    Number of subjects in period 1
    		Late life depression Control group
    Started
    55
    53
    Completed
    48
    52
    Not completed
    7
    1
         Consent withdrawn by subject
    2
    -
         incomplete PET + MRI dataset
    3
    -
         Vascular lesion
    1
    -
         PET technical failure
    1
    -
         Incomplete PET and MRI data
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 Includes 55 patients and 53 controls that were enrolled in the study prior to exclusion/drop-out

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 108 108
    Age categorical
    Participants were aged 55 years or older.
    Units: Subjects
        55 years or older
    		 108 108
    Gender categorical
    Gender categorized as Male or Female at baseline
    Units: Subjects
        Female
    		 76 76
        Male
    		 32 32
    Subject analysis sets

    Subject analysis set title
    Final analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes 48 patients and 52 controls with complete data. Exclusions: 2 patient withdrawals, 1 patient excluded for vascular lesion, 1 patient excluded for PET technical failure, and 4 subjects (3 patients, 1 control) excluded due to missing data.

    Subject analysis sets values
    		 Final analysis set
    Number of subjects
    100
    Age categorical
    Participants were aged 55 years or older.
    Units: Subjects
        55 years or older
    100
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Gender categorized as Male or Female at baseline
    Units: Subjects
        Female
    70
        Male
    30

    End points

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    End points reporting groups
    Reporting group title
    Late life depression
    Reporting group description
    		 Patients over age 55 with major depressive disorder.

    Reporting group title
    Control group
    Reporting group description
    		 Age- and gender-matched healthy controls with no history of depression or cognitive impairment.

    Subject analysis set title
    Final analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes 48 patients and 52 controls with complete data. Exclusions: 2 patient withdrawals, 1 patient excluded for vascular lesion, 1 patient excluded for PET technical failure, and 4 subjects (3 patients, 1 control) excluded due to missing data.

    Primary: Cortical amyloid burden (SUVR PET)

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    End point title
    		 Cortical amyloid burden (SUVR PET) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline (cross-sectional, single assessment)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: See attached publication for statistical analyses and results.
    End point values
    		 Late life depression Control group Final analysis set
    Number of subjects analysed
    48
    52
    100
    Units: Subjects with amyloid PET scan (SUVR)
    48
    52
    100
    Attachments
    		 Full publication – Takamiya et al., Sci Rep 2021
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first study assessment to last study assessment per subject
    Adverse event reporting additional description
    No serious adverse events were reported during the trial. One non-serious AE occurred, but did not result in study withdrawal. Subject withdrawals occurred for non-AE reasons, including technical issues, no longer wishing to participate, or missing data.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All subjects enrolled in the trial (Late-life depression and Control groups)

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 100 (1.00%)
    Cardiac disorders
    Bradycardia
    Additional description: Participant experienced sinus bradycardia with complaints of dizziness, cardiac palpitations and tinnitus. Immediate evaluation by cardiologist. Spontaneously cleared up after 30-60 minutes. Participant continued to participate in the study.
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    Cross-sectional study; some subjects excluded for technical issues or missing data. Imaging outcomes beyond primary objectives were exploratory. Planned longitudinal follow-up to assess conversion to Alzheimer’s disease was not performed.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35091333
    http://www.ncbi.nlm.nih.gov/pubmed/27539488
    http://www.ncbi.nlm.nih.gov/pubmed/28672181
    http://www.ncbi.nlm.nih.gov/pubmed/34354136
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