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    Clinical Trial Results:
    A randomised feasibility trial investigating Sativex® for the treatment of the Agitation & Aggression (A/A) in Alzheimer’s Dementia.

    Summary
    EudraCT number
    		 2020-001056-17
    Trial protocol
    		 GB  
    Global end of trial date
    23 Aug 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions
    Summary report(s)
    		 STAND CSR 17Jul24

    Trial information

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    Trial identification
    Sponsor protocol code
    3606
    Additional study identifiers
    ISRCTN number
    		 ISRCTN97163562
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Kings College London
    Sponsor organisation address
    KHPCTO F16, Guys Hospital, London, United Kingdom, SE1 9RT
    Public contact
    Chris Albertyn, Kings College London, +44 02078480548, chris.albertyn@kcl.ac.uk
    Scientific contact
    Chris Albertyn, Kings College London, +44 02078480548, chris.albertyn@kcl.ac.uk
    Sponsor organisation name
    South London & Maudsley NHS Foundation Trust
    Sponsor organisation address
    KHPCTO F16, Guys Hospital, London, United Kingdom, SE5 8AB
    Public contact
    Dag Aarsland , IoPPN, King’s College London, 16 De Crespigny Park, Camberwell, +44 2078480626, dag.aarsland@kcl.ac.uk
    Scientific contact
    Dag Aarsland, IoPPN, King’s College London, 16 De Crespigny Park, Camberwell, +44 2078480496, dag.aarsland@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
    23 Aug 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Aug 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Feasibility: To employ a mixed methods approach to explore the feasibility of a definitive multicentre randomized controlled trial (RCT) within residential nursing home settings of Sativex® for treatment of agitation and aggression in AD. Further, our primary objectives will be; 1. To explore rate of recruitment and retention in the target population, including determining facilitators and barriers. 2. To determine whether the cut-off of ‘clinically significant’ agitation for CMAI or NPI-NH influences rate of recruitment fora future confirmatory trial 3. To investigate the acceptability of an oral mucosal method of administration for this indication in terms of compliance and to care home staff in terms of adherence to the titration schedule. 4. To investigate the acceptability of a cannabinoid-based medicine, and explore impact of societal attitudes and stigma within this patient population as part of the qualitative evaluation.
    Protection of trial subjects
    Participants have the right to withdraw from the study at any time for any reason. The investigator also has the right to withdraw patients from the study drug in the event of inter-current illness, AEs, SAE’s, SUSAR’s, protocol violations, administrative reasons or other reasons. It is understood by all concerned that an excessive rate of withdrawals can render the study un-interpretable; therefore, unnecessary withdrawal of patients should be avoided. Should a patient wish to withdraw from the study, all efforts will be made to report the reason for withdrawal as thoroughly as possible, and to keep them for future outcome data collection. Upon confirming formal withdrawal, administration of Sativex® or placebo will immediately cease; STAND researchers will collect remaining supply from the care home and return to the pharmacy for destruction.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Nov 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: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    0
    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)
    2
    From 65 to 84 years
    16
    85 years and over
    11

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 53 [1]
    Number of subjects completed
    		 29

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen Failures: 24
    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: We do not count screening participants as enrolled
    Period 1
    Period 1 title
    Overall Trial
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sativex
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Dosing will be determined by number of sprays per day. Each spray reliably contains 2.7mg (THC)/2.5mg (CBD). Dosage will be titrated up to a maximum dose of 4 sprays per day (10.8mg THC/10mg CBD). This will be administered over the maximum duration of 4 weeks

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Sativex placebo will be administered using the same device (oromucosal spray), and contain ethanol, propylene glycol (50:50), with peppermint oil (.05%) flavourings and colourings. The Placebo will follow the same dosing schedule as the experimental (Sativex) arm and will be administered over the maximum duration of 4 weeks.

    Number of subjects in period 1
    		Sativex Placebo
    Started
    15
    14
    Completed
    15
    14
    Period 2
    Period 2 title
    Overall Trial (Both Arms combined)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Arm title
    		 Overall Trial (Both Arms Combined)
    Arm description
    		 -
    Arm type
    		 Both arms

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Overall Trial (Both Arms Combined)
    Started
    29
    Completed
    29

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sativex
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Sativex Placebo Total
    Number of subjects
    		 15 14 29
    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
        median (inter-quartile range (Q1-Q3))
    		 83.0 (77 to 86) 81.0 (75.0 to 87.0) -
    Gender categorical
    Units: Subjects
        Female
    		 9 5 14
        Male
    		 6 9 15

    End points

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    End points reporting groups
    Reporting group title
    Sativex
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    Overall Trial (Both Arms Combined)
    Reporting group description
    		 -

    Primary: Follow-up rate

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    End point title
    		 Follow-up rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    Week 4 and Week 8
    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: Please see uploaded report
    End point values
    		 Overall Trial (Both Arms Combined)
    Number of subjects analysed
    29
    Units: 29
        Week 4
    29
        Week 8
    29
    No statistical analyses for this end point

    Primary: CMAI completion rate

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    End point title
    		 CMAI completion rate [2]
    End point description
    End point type
    Primary
    End point timeframe
    Week 4 to Week 8
    Notes
    [2] - 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: Please see uploaded report
    End point values
    		 Overall Trial (Both Arms Combined)
    Number of subjects analysed
    29
    Units: 29
        Week 4
    29
        Week 8
    28
    No statistical analyses for this end point

    Primary: Participant Adherence

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    End point title
    		 Participant Adherence [3]
    End point description
    End point type
    Primary
    End point timeframe
    Weeks 1 – 4
    Notes
    [3] - 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: Please see uploaded report
    End point values
    		 Overall Trial (Both Arms Combined)
    Number of subjects analysed
    29
    Units: 29
    29
    No statistical analyses for this end point

    Primary: Randomisation rate

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    End point title
    		 Randomisation rate [4]
    End point description
    End point type
    Primary
    End point timeframe
    Screening period
    Notes
    [4] - 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: Please see uploaded report
    End point values
    		 Overall Trial (Both Arms Combined)
    Number of subjects analysed
    29
    Units: 29
    29
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to Week 8
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Sativex
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Sativex Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 14 (7.14%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Sativex Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 15 (26.67%)
    2 / 14 (14.29%)
    Eye disorders
    Eye disorders
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hepatobiliary disorders
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorders
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Skin/tissues disorders
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (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
    07 Apr 2021
    Protocol V4.0, 07-Apr-21
    11 May 2022
    Protocol Version 5.0: - Upper age limit increased to 95yrs - Change in blood screening conditions

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/40479610
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