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

MedCanDem

The behavioral and psychological symptoms of dementia affect up to 80% of long-term facilities residents with severe dementia. They seriously alter the quality of life of patients, relatives, and health professionals. Management involves correcting somatic and psychiatric factors and implementing non-drug interventions. Nevertheless, often drug treatments must be introduced with the limitations related to their effectiveness and adverse effects. The investigators hypothesize that medical cannabinoids will improve neuropsychiatric and behavioral symptoms of patients with severe dementia. The investigators assessed the feasibility and safety of administering a cannabis oil that contains tetrahydrocannabinol (THC) and Cannabidiol (CBD) during an initial study of about two years, observing an overall improvement, excellent tolerance to the treatment, and the possibility of reducing or even stopping other drugs. This research project aims to study the efficacy of medical cannabis oil in improving the quality of life of dementia patients experimenting with behavioral and psychological symptoms.

2023-09-29

2024-09-01

2024-09-01

Recruiting

Early phase I

24

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.

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2023-12-15