CANnabidiol for Behavioural Symptoms in Alzheimer’s Disease

Phase 1

• Conditions: Alzheimer's disease patients with BPSD; MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2019-002106-52-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-02
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified