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    Clinical Trial Results:
    CANnabidiol for Behavioural Symptoms in Alzheimer’s Disease

    Summary
    EudraCT number
    		 2019-002106-52
    Trial protocol
    		 GB  
    Global end of trial date
    24 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jul 2023
    First version publication date
    30 Jul 2023
    Other versions
    Summary report(s)
    		 Data report

    Trial information

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    Trial identification
    Sponsor protocol code
    CANBiS-AD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Dr Latha Velayudhan, King's College London, +44 02078480508, latha.velayudhan@kcl.ac.uk
    Scientific contact
    Dr Latha Velayudhan, King's College London, +44 02078480508, latha.velayudhan@kcl.ac.uk
    Sponsor organisation name
    South London and Maudsley NHS Foundation Trust
    Sponsor organisation address
    Denmark Hill, London, United Kingdom, SE5 8AZ
    Public contact
    Dr Latha Velayudhan, King's College London, +44 02078480508, latha.velayudhan@kcl.ac.uk
    Scientific contact
    Dr Latha Velayudhan, King's College London, +44 02078480508, latha.velayudhan@kcl.ac.uk
    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
    04 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    24 May 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    (i)Acceptability: To investigate the acceptability of the randomisation procedure and delivery of the intervention (CBD or placebo in capsule form) to the AD patients and carers (recruitment rates). (ii)Retention: To measure the study retention rate (follow-up rates). (iii)Compliance: To assess compliance with treatment (adherence).
    Protection of trial subjects
    Category of withdrawal I (Voluntary withdrawal) - As per the Declaration of Helsinki, all participants will have the right to withdraw from the study at any time without giving any reason without any prejudice to their future medical care and will be informed as such. An independent Data Monitoring Committee (DMC) will be constituted to act in an advisory capacity to meet regularly (at approximately 6 monthly intervals) to review accumulating data and to monitor patient safety and outcome
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 May 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    1
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 22 [1]
    Number of subjects completed
    		 15

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen fail: 6
    Reason: Number of subjects
    		 Physician decision: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 participant withdrew after randomisation but before any study procedures so was not included in the analysis.
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CBD arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    cannabidiol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Within the CBD arm, all patients will start on 200 mg/day and thereafter they will receive an increased dose of 400 mg/day from day 8 and 600mg/day from day 15. If a patient begins to experience intolerable side effects, the dose will be dropped to the last tolerated dose.

    Arm title
    		 placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo arm patients will receive identical number of capsules over the study period.

    Number of subjects in period 1 [2]
    		CBD arm placebo
    Started
    8
    7
    Completed
    8
    7
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 participant withdrew after randomisation but before any study procedures so was not included in the analysis.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 15 15
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 77.91 ± 0.08 -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    CBD arm
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Primary: Overall adherence

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    End point title
    		 Overall adherence [1]
    End point description
    End point type
    Primary
    End point timeframe
    Randomisation to week 6
    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: No statistical analysis
    End point values
    		 CBD arm placebo
    Number of subjects analysed
    8
    7
    Units: Retention Rate
    8
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Screening to day 71
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    CBD arm
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Serious adverse events
    		 CBD arm placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 CBD arm placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 8 (75.00%)
    1 / 7 (14.29%)
    Investigations
    liver enzymes raised
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    5
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2020
    Protocol v3.0 submitted in response to REC comments
    28 Sep 2021
    IMPD updated to extend capsule shelf life

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Dec 2021
    The study had a brief pause in recruitment for about 8 weeks (Dec 2021 to Jan 2022) due to delays in approval and re-labelling and shipment of IMP supply. The overall delay in study start meant tight limitations for recruitment and IMP expiry (30th April 2022). This meant the final recruitment date for the study was 18th March 2022 to ensure that the patient recruited on that date completed the trial by the 30th of April 2022
    31 Jan 2022

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    We faced a number of challenges due to multiple waves of the COVID-19 pandemic and risk to potential trial participants, who were already vulnerable to covid because of their age and co-morbid health conditions.
    For support, Contact us.
    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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