Medical cannabis for improving symptoms during severe dementia disorders in long-term care facility in Geneva
Information about the drug that will be tested in the study
Administration
Oral drops daily
Will all participants receive the same drug?
The study is divided into two 8-week periods. Participants will be selected by chance to receive one of the following options:
- Oral drops of Cannabis Oil for eight weeks followed by oral drops of placebo or a further eight weeks
- Oral drops of placebo for eight weeks followed up by a further eight weeks of oral drops of Cannabis Oil
A placebo is also called a dummy treatment which is an inactive substance identical in appearance to the compound being tested with no active therapeutic effect.
Neither the participant, the health staff of the care facilities nor the study team will know if the person is receiving the Cannabis Oil or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of the study is to evaluate the efficacy of medical cannabis oil in improving the quality of life of people with severe dementia experiencing behavioural and psychological symptoms.
How long will the treatment last?
Participants will take medical cannabis oil for 8 weeks.
What your involvement will entail?
- During the study, participants will be asked to complete tests to assess agitation and psychiatric symptoms
- To complete some laboratory/biological tests (i.e. blood tests, blood pressure) to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the compound tested in the study.
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the Placebo-Controlled Period, key inclusion criteria for participants are:
- Be between 55 years or older
- Have a diagnosis of severe dementia (i.e. Alzheimer’s disease, vascular dementia, mixed dementia)
- Have a score above 3 in the Clinical Dementia Rating (CDR) test. This would suggest that the person has a severe cognitive impairment
- Have a score above 10 in the Neuropsychiatric Inventory (NPI) test. This would suggest that the person has persisting behaviour problems
- Have not had SARS -CoV-2 (COVID 19) within two weeks of commencing the trial or be fully vaccinated.
Who cannot participate in the study?
Exclusion criteria for the Placebo-controlled period include:
- A disease or medical condition that may interfere with the study assessments and will make the participant unsuitable for participation in or completion of the trial procedures (i.e.severe kidney failure, orthostatic hypotension or severe organ deficiency such as cardiac, pulmonary, hepatic, renal insufficiency)
- Major changes or instability of psychotropic medication in the past week
- Having taken tetrahydrocannabinol (THC) and/or Cannabidiol (CBD) in the past 7 days.
Information for your doctor
Clinicaltrials.gov identifier
NCT05432206
Study contact information
Federica Bianchi
+41 76 4947150
Fondation FAHPA
Link to full text
https://clinicaltrials.gov/ct2/show/NCT05432206
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) in December 2023.
This document has been reviewed by the pharmaceutical company running this trial.
This document has been reviewed by a member of the European Dementia Carers Working Group.
