A Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia.

NCT ID: NCT06217146

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-12
• Study Completion Date: 2024-03-10

Brief Summary

This double-blind, placebo-controlled study is designed to assess the effectiveness of, MediCane's medical cannabis oil extracted from MediCane's proprietary strain into GMP-grade olive oil, as an add-on therapy to standard of care (SoC), in reducing agitation and disruptive behaviors in subjects with dementia including probable AD.

Conditions

Agitation,Psychomotor; Disruptive Behavior; Dementia; Alzheimer Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MediCane's medical cannabis oil

Group Type: EXPERIMENTAL

Medical Cannabis

Intervention Type: DRUG

MediCane's medical cannabis oil

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Oil

Intervention Type: DRUG

Placebo Oil

Interventions

Medical Cannabis

MediCane's medical cannabis oil

Intervention Type: DRUG

Placebo Oil

Placebo Oil

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects are Male or Female age ≥50 years.
• Subjects have a diagnosis of major neurocognitive disorder (previously dementia) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Criteria for at least 6 months prior to screening or a diagnosis of probable AD using the NINCDS-ADRDA clinical criteria.
• Subjects on antipsychotic medications may be included in the study.
• Subject exhibits agitation/aggression with a Neuropsychiatric Inventory (NPI-12)-agitation/aggression subdomain score of four or higher (≥4) at screening.
• Subject has a legal guardian who is able and willing to provide ICF and able to provide - information in writing. The caregiver should be spending enough time with the subject on a regular basis in order to provide valid information as requested.
• Subjects are on stable SoC for treatment of agitation and disruptive behaviors for at least 2 weeks prior to the screening visit.
• Subjects on Acetyl Choline Esterase inhibitors, antifungals, macrolide antibiotics and anti-hypertensive therapy including ACE inhibitors should be on stable doses for at least 2 weeks prior to screening visit or if changed, at least 2 weeks prior to visit 1.
• Subject's Mini Mental State Exam score (MMSE) is 24 or less at screening.

Exclusion Criteria

• Subject without a legal guardian.
• Subject with any current unstable medical condition.
• Subject has any unstable condition involving fluid retention, pulmonary infiltrates, congestive heart failure, respiratory symptoms or disease, or cardiac symptoms or disease.
• Subject has one of the following hepatic /renal disorders:

1. Confirmed and unexplained impaired hepatic function as indicated by screening AST or ALT>3 the upper limit of normal (ULN) or total bilirubin > 2 ULN.

2. Chronic kidney disease of Stage > 4, according to National Kidney Foundation Kidney Disease Outcome Quality Initiative guidelines for chronic kidney disease.

• Subject has epilepsy.
• Subject has a history of hypersensitivity to any cannabinoid.
• Subject has the presence or history of a primary psychotic psychiatric disorder or subject has clinically significant delusions or hallucinations secondary to the neurodegenerative disease (NPI-12 delusions or hallucinations sub-score of 4 or higher (≥4).
• Subject suffering from delirium as defined in Appendix B - Criteria for Delirium.
• Current inpatient hospitalization.
• Subject has other health-related factors that could explain behavioral disturbances (electrolyte disturbances, infectious diseases, etc.).
• Subject has a satisfactory response to antipsychotic treatments.
• Subjects treated with one of the following medications: opiates, primidone, phenobarbitol, carbamazepine, rifampicin, rifabutin, troglitazone, hypericum perforatum, or valproic acid within 30 days from Visit 1.
• Subjects currently on medication known to interact with Cannabis-based medications are excluded; Subjects taking Cannabis-based therapies are excluded if within the past 2 weeks from Visit 1.
• Subjects with a history of addiction or drug abuse.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M. H MediCane Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neta Rimmerman, PhD

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

Laniado Hospital

Netanya, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Tel-Aviv Sourasky Medical Center Ichilov

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

AGM-01

Identifier Type: -

Identifier Source: org_study_id