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    Clinical Trial Results:
    Molecular imaging for the early diagnosis and monitoring of Alzheimer’s disease in old individuals with cognitive disturbances: an ADNI-compatible prospective study

    Summary
    EudraCT number
    		 2011-004415-24
    Trial protocol
    		 IT  
    Global end of trial date
    30 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jul 2021
    First version publication date
    28 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    09/2011MolecularImaging
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IRCCS CENTRO SAN GIOANNI DI DIO
    Sponsor organisation address
    via Pilastroni 4, Brescia, Italy,
    Public contact
    NA, IRCCS CENTRO SAN GIOANNI DI DIO, +39 030 3501362, gfrisoni@fatebenefratelli.it
    Scientific contact
    NA, IRCCS CENTRO SAN GIOANNI DI DIO, +39 030 3501362, gfrisoni@fatebenefratelli.it
    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
    07 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main study objective is to expand the investigation of diagnostic and monitoring basic markers (structural MRI, tau/abeta42 levels in the CSF, FDG PET) to advanced marker, such as molecular imaging. We will use the [11C]PK11195 (pk) that represents a validated and specific PET radioligand marker of activated microglia.
    Protection of trial subjects
    MRI: a questionnaire is administered to the patient prior to MRI in order to determine eligibility for the examination. Lumbar puncture: the procedure is performed by trained personnel. The patient is kept lying and monitored for two hours after the procedure in order to avoid headache and other potential adverse events PET: the procedure is performed by trained personnel. Special attention is paid to explaining the procedures to the patient and to allow maximization of the patient's comfort inside the scanner.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2011
    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
    Italy: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    3
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment lasted from December 2011 to August 2013. It took place in two Memory Clinics in Brescia, Italy.

    Pre-assignment
    Screening details
    		 MCI patients are screened from those referred to memory clinics due to patient complaint or caregiver report of memory or other cognitive disturbance, presence of objective memory or other cognitive domain impairment and absence of functional impairment. Thirty patients refused to participate in the study.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PK-PET
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    [11C](R)-PK11195
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The average radiotracer dose administered to patients was 373.6 MBq. The [11C](R)-PK11195 radiotracer was injected 30 seconds before the start of acquisitions. Data were collected in dynamic mode over 30 minutes, resulting in dynamic images of regional uptake of [11C](R)-PK11195.

    Number of subjects in period 1
    		PK-PET
    Started
    8
    Completed
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PK-PET
    Reporting group description
    		 -

    Reporting group values
    		 PK-PET Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 3 3
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Age continuous
    Mean age of 100 patients with mild cognitive impairment enrolled in the study is 68 +/- 19 years. Mean age of 8 MCI patients included in the experimental arm is 64+/- 9.
    Units: years
        arithmetic mean (standard deviation)
    		 64 ± 9 -
    Gender categorical
    The proportion of female in the PK-PET arm is 3/9 (33%)
    Units: Subjects
        Female
    		 3 3
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    PK-PET
    Reporting group description
    		 -

    Primary: correlation between [18F]FDG-PET and [11C]-(R)-PK11195 PET.

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    End point title
    		 correlation between [18F]FDG-PET and [11C]-(R)-PK11195 PET. [1]
    End point description
    End point type
    Primary
    End point timeframe
    The statistical design was adopted to test whether the strength of the inverse correlation between microglia and metabolism was due to the spatial overlap between the two signals.
    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: Statistical analyses for the primary endpoint consists of imaging analyses that can not be filled in the web interface.
    End point values
    		 PK-PET
    Number of subjects analysed
    8
    Units: 0.804
        number (not applicable)
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    adverse events are collected during the entire study period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No serious and non-serious adverse events occurred.

    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.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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