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Dementia with Behavioral DisturbancePhase 2/3MedCanDemNCT05432206

MEDical CANnabis for Improving Symptoms During Severe DEMentia Disorders in Long-term Care Facility in Geneva

A Phase 2/3 study testing Cannabis Sativa Oil in people with Dementia with Behavioral Disturbance, run by Fondation pour l'accueil et l'hébérement des personnes âgées at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Dementia with Behavioral Disturbance
What is being tested?
Cannabis Sativa Oil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
1 siteSwitzerland
Study dates
29 Sep 2023to 29 Nov 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • FAHPA

    Geneva, Canton of Geneva, 1206

Other trials in Switzerland

About this study

Official title: 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

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.

Read more

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.

Read the 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 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.

Being tested
Cannabis Sativa Oil, Placebo
Keywords
Dementia, Medical cannabis, Cannabinoids, Behavioral symptoms
Medical subject headings
Dementia, Behavioral Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabis Sativa OilDrug

    Cannabis Sativa oil standardized: 11 mg THC/g and 22 mg CBD/g.

  • PlaceboDrug

    Hemp virgin seed oil

Study groups in NCT05432206
Study groupRoleWhat they receive
Cannabis Sativa Oil first, then PlaceboExperimentalThis arm will start with the active comparator for the first period and change to the placebo in the second period
Receives: Drug: Cannabis Sativa Oil; Drug: Placebo
Placebo first, then Cannabis Sativa OilExperimentalThis arm will start with the placebo for the first period and change to the active comparator in the second period
Receives: Drug: Cannabis Sativa Oil; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohen-Mansfield Agitation Inventory Scale (CMAI)

    Change from baseline in the Cohen-Mansfield Agitation Inventory score. Scores range from 29 to 203 - higher scores mean a worse outcome ( A total score >45 is usually regarded as clinically significant agitation).

    Measured: 4 and 8 weeks - after 1 week washout

Secondary outcomes (11)

  1. Neuropsychiatric Inventory (NPI)

    Change from baseline in the Neuropsychiatric Inventory score. Scores range from 0 to 144 - higher scores mean a worse outcome.

    Measured: 4 and 8 weeks - after 1 week wash-out

  2. Unified Parkinson disease rigidity scale (UPDRS)

    Change from baseline in the Unified Parkinson disease rating scale (UPDRS - item 22) rigidity score. Scores range from 0 to 4 - higher scores mean a worse outcome.

    Measured: 4 and 8 weeks - after 1 week wash-out

  3. Pain (Doloplus)

    Change from baseline in the Doloplus score. Scores range from 0 to 30 - higher scores mean a worse outcome.

    Measured: 4 and 8 weeks - after 1 week wash-out

  4. Daily activity

    Change from baseline in the score evaluating the most incapacitating daily activity. Scores range 0 to 10 - higher scores mean a greater difficulty for patients.

    Measured: 4 and 8 weeks - after 1 week wash-out

  5. Behavioral Trouble

    Change from baseline in the score evaluating the most incapacitating behavioral trouble. Scores range 0 to 10 - higher scores mean a greater trouble.

    Measured: 4 and 8 weeks - after 1 week wash-out

  6. Team

    Score evaluating the team's impression of change. Scores range 1 to 7. Higher scores mean greater deterioration.

    Measured: 4 and 8 weeks - after 1 week wash-out

  7. Family

    Score evaluating the family's impression of change. Scores range 1 to 7. Higher scores mean greater deterioration.

    Measured: 4 and 8 weeks - after 1 week wash-out

  8. Evolution of dosages for each patient

    Dosage adjustments of medical cannabis and psychotropic drugs.

    Measured: 4 and 8 weeks

  9. Change in enzymatic activity

    Change in cytochromes P450 (1A2, 2B6, 2C9, 2C19,2D6 and 3A4/5 ) enzymatic activities using Geneva cocktail approach.

    Measured: 8 weeks

  10. Therapeutic Drug Monitoring

    Therapeutic drug monitoring of plasma concentrations of Tetrahydrocannabinol, 11-Hydroxy-tetrahydrocannabinol, 11-nor-9-carboxy-tetrahydrocannabinol, Cannabidiol.

    Measured: 8 weeks

  11. Endocannabinoids

    Evaluation of plasma levels of endocannabinoids - anandamide and 2-arachidonylglycerol.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2022
  2. Study start29 Sep 2023
  3. Primary completion29 Nov 2024
  4. Study completion29 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05432206
Sponsor's protocol ID
MedCanDem
Acronym
MedCanDem
Status last verified
Dec 2024
First submitted
8 Jun 2022
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37293434

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cannabis Sativa Oil in people with Dementia with Behavioral Disturbance, run by Fondation pour l'accueil et l'hébérement des personnes âgées at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohen-Mansfield Agitation Inventory Scale (CMAI) (time frame: 4 and 8 weeks - after 1 week washout). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05432206, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

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