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

NCT05432206 | Completed Phase 2 DMC

• 1 other identifier: MedCanDem
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Dementia with Behavioral Disturbance

Keywords

Dementia; Medical cannabis; Cannabinoids; Behavioral symptoms

Outcome Measures

Primary Outcomes (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).

  4 and 8 weeks - after 1 week washout

Secondary Outcomes (11)

• Neuropsychiatric Inventory (NPI)

  4 and 8 weeks - after 1 week wash-out

• Unified Parkinson disease rigidity scale (UPDRS)

  4 and 8 weeks - after 1 week wash-out

• Pain (Doloplus)

  4 and 8 weeks - after 1 week wash-out

• Daily activity

  4 and 8 weeks - after 1 week wash-out

• Behavioral Trouble

  4 and 8 weeks - after 1 week wash-out

Other Outcomes (5)

• Blood Count 1

  8 weeks

• Blood Count 2

  8 weeks

• Blood Count 3

  8 weeks

Study Arms (2)

Cannabis Sativa Oil first, then Placebo

EXPERIMENTAL

This arm will start with the active comparator for the first period and change to the placebo in the second period

Drug: Cannabis Sativa Oil; Drug: Placebo

Placebo first, then Cannabis Sativa Oil

EXPERIMENTAL

This arm will start with the placebo for the first period and change to the active comparator in the second period

Drug: Cannabis Sativa Oil; Drug: Placebo

Interventions

Cannabis Sativa Oil DRUG

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

Cannabis Sativa Oil first, then Placebo; Placebo first, then Cannabis Sativa Oil

Placebo DRUG

Hemp virgin seed oil

Cannabis Sativa Oil first, then Placebo; Placebo first, then Cannabis Sativa Oil

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation pour l'accueil et l'hébérement des personnes âgées: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

FAHPA

Geneva, Canton of Geneva, 1206, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 37293434 DERIVED

Related Links

• Study Protocol

MeSH Terms

Conditions

Dementia; Behavioral Symptoms

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Sophie Pautex, Prof.

  HUG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 27, 2022
• Study Start: September 29, 2023
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)