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    Summary
    EudraCT Number:2019-002106-52
    Sponsor's Protocol Code Number:CANBiS-AD
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-01-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2019-002106-52
    A.3Full title of the trial
    CANnabidiol for Behavioural Symptoms in Alzheimer’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CANnabidiol for Behavioural Symptoms in Alzheimer’s Disease
    A.3.2Name or abbreviated title of the trial where available
    CANBiS-AD
    A.4.1Sponsor's protocol code numberCANBiS-AD
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKing's Health Partner's R&D Challenge Funds
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportPsychiatric Research Trust
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportRosetrees' Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointDr Latha Velayudhan
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Old Age Psychiatry
    B.5.3.2Town/ city6th Floor, Main IoPPN Building, De Crespigny Park
    B.5.3.3Post codeSE5 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02078480508
    B.5.6E-maillatha.velayudhan@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorSouth London and Maudsley NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKing's Health Partner's R&D Challenge Funds
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportPsychiatric Research Trust
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportRosetrees' Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointDr Latha Velayudhan
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Old Age Psychiatry
    B.5.3.2Town/ city6th Floor, Main IoPPN Building, De Crespigny Park
    B.5.3.3Post codeSE5 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02078480508
    B.5.6E-maillatha.velayudhan@kcl.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCannabidiol
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCannabidiol (CBD)
    D.3.9.2Current sponsor codeCannabidiol (CBD)
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's disease patients with BPSD
    E.1.1.1Medical condition in easily understood language
    Alzheimer's disease patients with behavioural and psychological symptoms e.g. anxiety, agitation, hallucinations and delusions
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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).




    E.2.2Secondary objectives of the trial
    (i)To measure key outcome domains for patients including clinical measures -BPSD, cognition, quality of life, smell functioning, daily functioning and carer’s distress
    (ii)To assess the safety (adverse events) and tolerability (side-effects) of CBD treatment
    (iii)To describe the variance and distribution of quantitative outcomes to pilot effect sizes and inform the design and sample size calculation in the future large-scale RCT
    iv)To investigate the acceptability of the questionnaires used to measure the key outcome domains (percentage of completion rates)

    Mechanistic sub-study: We aim to investigate the mechanistic basis of any CBD effect observed during the RCT using functional brain imaging and spectroscopy.

    Qualitative interviews: The aim of the qualitative interviews will be to explore participants’ experiences of taking part in the trial including what
    encouraged them to take part, their views on the intervention and how they are finding the trial in general.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Mechanistic sub-study (included as addendum to main protocol, version 1.0)

    Aims: We aim to investigate the mechanistic basis of any CBD effect observed during the RCT using functional brain imaging.

    Methods: Nested within the main trial, we will carry out a mechanistic sub-study using magnetic resonance imaging (MRI). Neuroimaging (task based and resting state fMRI; spectroscopy and structural MRI) data will be acquired using well-established protocols on the the 3 Tesla scanner (GE SIGNA HDx 3.0T MR scanner system) at the NIHR King's Wellcome CRF or Centre for neuroimaging Sciences at Denmark Hill.
    Neuroimaging will be done pre-treatment (baseline visit) and then after 6 weeks of treatment (follow-up visit 3) and will be offered to all participants in the trial. Each patient will be scanned over a 60-minute period.

    E.3Principal inclusion criteria
    (1) Age 55 and above from both genders;
    (2) Living within the SLAM/South London region;
    (3) Diagnosis of AD according to the criteria of National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA);
    (4) Clinical Dementia Rating (CDR) score between 0.5-2;
    (5) BPSD lasting for at least 2 weeks with total score on Neuropsychiatric Inventory (NPI) ≥4 and at least 1 item with moderate frequency or severity on one of the domains of anxiety, agitation, hallucinations or delusions;
    (6) If treated with cholinesterase inhibitors (donepezil, rivastigmine or galantamine) and/or memantine, dosage must have been stable for at least 1 month; If ChEIs and/or memantine has been discontinued, they may enrol 1 month following discontinuation.
    (7) Ability to participate in study evaluation and ingest oral medication.
    (8) Reliable informant/caregiver.
    (8) Written informed consent from participant or their legally authorised representative.

    Eligibility criteria for caregivers:
    (1) See the patient for an average of 6 hours per week
    (2) Willing to attend all study visits with the participant and participate in weekly calls
    (3) Able to answer questions about the participant’s behavioural and psychological symptoms, daily activities, quality of life, memory, health and any side effects that they may be experiencing from the study medication
    E.4Principal exclusion criteria
    (1) Presence or history of other psychiatric or neurological disorders (e.g. psychotic disorders, schizophrenia, major depressive illness including suicidal ideation, stroke, epilepsy) or severe intercurrent physical illness that could interfere with the conduct of the study.
    (2) Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal Behavior iItems occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide.
    (3) Changes in dosage of antidepressants within 4 weeks before randomization and during study, and changes in dosage antipsychotics or benzodiazepines within 2 weeks prior to randomization and during study.
    (4) Use of co-medication that has a clinically relevant interaction with the CYP2C19 or CYP3A classes of liver enzymes will not be permitted from two weeks before inclusion until the end of the study. Examples of co-medication that will be not allowed will include CYP3A4 inhibitors (such as itraconazole, ketoconazole, posaconazole, fluconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, telaprevir, boceprevir, imatinib, ticagrelor, voriconazole), CYP3A4 inducers (such as grapefruit juice, carbamazepine, efavirenz, nevirapin, etravirin) and CYP2C19 inhibitors (such as moclobemine, fluvoxamine, chloramphenicol, fluoxetine).
    (5) If the patient has participated in other interventional clinical studies within 30 days of baseline.
    (6) Female patients who are pregnant or lactating
    (7) Female patients of childbearing potential* who are not willing to use a highly effective method of contraception** for the duration of the trial (from the date of consent until entire study duration, i.e., until the 4 weeks follow up visit post-treatment) to prevent pregnancy or abstain from heterosexual activity. *Females of childbearing potential are females who have experienced menarche and are not surgically sterilised (e.g. hysterectomy or bilateral salpingectomy) or postmenopausal (defined as at least 1 year since last regular menstrual period).
    ** Highly effective methods of birth control are those with a failure rate of < 1% per year when employed consistently and correctly, e.g. • combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal • progestogen-only hormonal contraception associated with inhibition of ovulation 1: o oral o injectable o implantable 2 • intrauterine device (IUD) • intrauterine hormone-releasing system ( IUS) • vasectomised partner
    Sexual abstinence is considered to be highly effective method only if defined as refraining from heterosexual activity from the date of consent until entire study duration, i.e., until the 4 weeks follow up visit post-treatment. The reliability of this method should be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
    (8) Known hypersensitivity to CBD gelatine or micro-crystalline cellulose.
    (9) Mechanistic sub-study only: Patients who have any contraindications to MRI, including: pacemakers, metallic foreign body in the eye, aneurysm clip in their brain, severe claustrophobia where patients would not be able to tolerate the scan etc
    E.5 End points
    E.5.1Primary end point(s)
    1. Recruitment: number of participants recruited, consented and randomised in 9 months
    2. Percentage of patients compliant* with treatment by the end of 6-weeks
    3. Retention rate (measured by drop-out) by the end of 6-week treatment and missing data

    *Defined as at least 60% of the dose taken, measured by pill count
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the last visit of the final patient is complete
    E.5.2Secondary end point(s)
    Change in mean score at week 6 compared to baseline (pre-treatment) and 95% confidence intervals for the following measures:

    NeuroPsychiatry Inventory (NPI-C)
    Standardised Mini-Mental State Examination (SMMSE)
    Addenbrooke's Cognitive Examination-III (ACE-III)
    Hopkins Verbal Learning Test (HVLT)
    Cohen Mansfield Agitation Inventory (CMAI)
    Clinical Global Impression of Change (CGIC)
    DEMQOL and DEMQOL-Proxy
    Bristol Activities of Daily Living Scale (BADLS)
    Smell Functioning Test (UPSIT)

    Tolerability: Assessed by self-report of side-effects, medication discontinuation and the UKU side-effect rating scale for psychotropic drugs

    Safety parameters: Bloods Haematology (Haemoglobin, Red blood cell count, Platelet count, white blood cell count and differential count), Clinical chemistry (Sodium, Potassium, Creatinine, Urea); Glucose; Liver function test (Total bilirubin, Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline phosphatase); cholesterol (total, LDL, HDL); T3, T4 and Thyoridthyroid stimulating hormone; Vital signs: Heart rate and Blood pressure; Physical examination; Electrocardiogram (ECG)- 12 lead ECG

    Mechanistic sub-study: the within-subject change in brain function and connectivity [as measured using task-based (verbal learning) and resting state fMRI] following treatment between the two treatment conditions (CBD and placebo)

    Qualitative interviews: The aim of the qualitative interviews will be to explore participants’ experiences of taking part in the trial including what
    encouraged them to take part, their views on the intervention and how they are finding the trial in general.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the last visit of the final patient is complete
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial will be defined as database lock.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Some of the participants may not have capacity to give informed consent. In such cases, consent will be sought from their legal representative/nearest relative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No arrangements are being made for continued access for the study participant to receive CBD after the trial . Once the participant has been discontinued from the study, the participant’s GP will continue to manage them according to the routine standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-19
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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