MEDical CANnabis for Improving Symptoms During Severe DEMentia Disorders in Long-term Care Facili… (NCT05432206) | Clinical Trial Compass
CompletedPhase 2/3
MEDical CANnabis for Improving Symptoms During Severe DEMentia Disorders in Long-term Care Facility in Geneva
Switzerland27 participantsStarted 2023-09-29
Plain-language 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 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.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cohen-Mansfield Agitation Inventory Scale (CMAI)
Timeframe: 4 and 8 weeks - after 1 week washout
Trial details
NCT IDNCT05432206
SponsorFondation pour l'accueil et l'hébérement des personnes âgées