Status:
COMPLETED
MEDical CANnabis for Improving Symptoms During Severe DEMentia Disorders in Long-term Care Facility in Geneva
Lead Sponsor:
Fondation pour l'accueil et l'hébérement des personnes âgées
Collaborating Sponsors:
University Hospital, Geneva
Conditions:
Dementia with Behavioral Disturbance
Eligibility:
All Genders
55+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 heal...
Detailed Description
The study design is a placebo-controlled cross-over trial. The patients, the relatives, the health care professionals, and the study staff will be blinded. Medical cannabis treatment is a cannabis oi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05432206
Start Date
September 29 2023
End Date
November 29 2024
Last Update
December 17 2024
Active Locations (1)
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1
FAHPA
Geneva, Canton of Geneva, Switzerland, 1206