MEDical CANnabis for Improving Symptoms During Severe DEMentia Disorders in Long-term Care Facility in Geneva
NCT ID: NCT05432206
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
27 participants
INTERVENTIONAL
2023-09-29
2024-11-29
Brief Summary
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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.
Detailed Description
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Medical cannabis treatment is a cannabis oil that contains THC and CBD in a 1:2 ratio. The initial dose of 7 drops (2.5 mg THC and 5 mg CBD) will be gradually augmented and adjusted individually to a maximum of 56 drops (20 mg THC and 40 mg CBD) per day, divided into two administrations. Placebo is an edible oil with the same color, smell, and flavor as medical cannabis oil given with the same dosage scheme.
Patients will take medical cannabis oil for 8 weeks, in addition to their usual treatments.
The study is divided into two 8-week periods. Participants will be randomized 1:1 between cannabinoids/placebo and placebo/ cannabinoids sequences and will receive the cannabis oil during one of these periods and the placebo during the other.
Participants will observe a wash-out week between the two study periods, and a final observation week without treatment intake is planned at the end of the second period.
Rating scales to evaluate the efficacy will be assessed before treatment, after 28 days, at the end of periods, and at the end of the study. Blood pressure will be evaluated daily. Vital signs, blood formula, and the reduction or discontinuation of other drugs will be recorded periodically. In addition, the health professionals' and relatives' appraisals will be recorded at five-time points.
A blood test at the beginning and the end of each period will allow the evaluation of the potential drug-drug interactions and the pharmacokinetics of cannabinoids. The cytochromes P450 (1A2, 2B6, 2C9, 2C19, 2D6, 3A4/5) enzymatic activity will be evaluated by phenotyping after Geneva micro-cocktail intake. The therapeutic drug monitoring will be measured at a steady-state characterizing the plasma through levels of THC, its two metabolites, 11-hydroxy-tetrahydrocannabinol and free carboxy-tetrahydrocannabinol, and CBD.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Cannabis Sativa Oil first, then Placebo
This arm will start with the active comparator for the first period and change to the placebo in the second period
Cannabis Sativa Oil
Cannabis Sativa oil standardized: 11 mg THC/g and 22 mg CBD/g.
Placebo
Hemp virgin seed oil
Placebo first, then Cannabis Sativa Oil
This arm will start with the placebo for the first period and change to the active comparator in the second period
Cannabis Sativa Oil
Cannabis Sativa oil standardized: 11 mg THC/g and 22 mg CBD/g.
Placebo
Hemp virgin seed oil
Interventions
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Cannabis Sativa Oil
Cannabis Sativa oil standardized: 11 mg THC/g and 22 mg CBD/g.
Placebo
Hemp virgin seed oil
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
55 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Fondation pour l'accueil et l'hébérement des personnes âgées
OTHER
Responsible Party
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Principal Investigators
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Sophie Pautex, Prof.
Role: PRINCIPAL_INVESTIGATOR
HUG
Locations
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FAHPA
Geneva, Canton of Geneva, Switzerland
Countries
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References
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Bianchi F, Pautex S, Wampfler J, Curtin F, Daali Y, Desmeules JA, Broers B. Medical cannabinoids for painful symptoms in patients with severe dementia: a randomized, double-blind cross-over placebo-controlled trial protocol. Front Pain Res (Lausanne). 2023 May 24;4:1108832. doi: 10.3389/fpain.2023.1108832. eCollection 2023.
Related Links
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Other Identifiers
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MedCanDem
Identifier Type: -
Identifier Source: org_study_id