MedCanDem

CompletedPhase 2 / PHASE3

MEDical CANnabis for Improving Symptoms During Severe DEMentia Disorders in Long-term Care Facility in Geneva

Randomized Double-blind Cross-over Placebo-controlled Trial to Study the Impact on Behavioral and Psychological Symptoms of Dementia of Medical Cannabinoids (CBD/THC) in Patients with Severe Dementia in Long-term Care Facilities in Geneva

Lead sponsor

Fondation pour l'accueil et l'hébérement des personnes âgées

Asset

Cannabis Sativa Oil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia, Mixed / unspecified dementia

Key I/E criterion

•Multiple dementia etiologies

Primary endpoint

•Cohen-Mansfield Agitation Inventory Scale (CMAI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDMedCanDem

NCT IDNCT05432206

Timeline

Milestones

Study first posted2022-06-27actual

Study start2023-09-29actual

Primary completion2024-11-29actual

Study completion2024-11-29actual

Last update posted2024-12-17actual

Assets

Drug assets

Cannabis Sativa Oil

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementiaMixed / unspecified dementia

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with severe dementia from different origins (Alzheimer's disease, vascular, mixed)

•Clinical Dementia Rating ≥3

•Persisting behavior problems (Neuropsychiatric Inventory [NPI] score > 10) notwithstanding optimal conventional treatment

•SARS-CoV-2 recovered for two weeks, or SARS-CoV-2 fully vaccinated

•Consent obtained from the representative in the medical field according to art 378 Swiss Civil Code (SCC)

Exclusion criteria

•Severe organ deficiency such as cardiac, pulmonary, hepatic, renal insufficiency, or unstable heart rhythm

•Symptomatic orthostatic hypotension

•Major changes or instability of psychotropic medication in the week preceding the study enrolment

•Having taken THC and/or CBD in the 7 days before enrolment

•Hemoglobin < 10 g/dl

•Severe kidney failure defined by cockcroft calculation <30 ml/mn

•Alanine aminotransferase and aspartate aminotransferase > 3x upper limit of normal

•Any other medical conditions that would prevent participation in the whole study protocol.

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Behavior / neuropsychiatric

Other clinical outcomes

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Cohen-Mansfield Agitation Inventory Scale (CMAI)

Time frame:4 and 8 weeks - after 1 week washout

change from baseline, improvement

Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:4 and 8 weeks - after 1 week wash-out

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other clinical outcomes

1 endpoint

Other/protocol endpoint

Blood pressure

Time frame:through study completion, an average of 5 months

descriptive