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

NCT06217146 | Terminated DMC

• 1 other identifier: AGM-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Part 1 Safety (Adverse Events)

  Number of participants with treatment-related adverse events as assessed by severity. protocol.

  Up to 22 weeks

• Part 2 Efficacy (CMAI)

  Change in agitation and aggression from baseline to Week 12 as measured using the Cohen-Mansfield Agitation Inventory-Community (CMAI-C), a 37-item scale that measures the types and frequencies of agitated behaviors, each rated on a 7-point scale of frequency, where higher scores indicate greater agitation severity.

  12 weeks

Secondary Outcomes (1)

• Part 1 Efficacy (NPI-12)

  up to 18 weeks

Study Arms (2)

MediCane's medical cannabis oil

EXPERIMENTAL

Drug: Medical Cannabis

Placebo

PLACEBO COMPARATOR

Drug: Placebo Oil

Interventions

Medical Cannabis DRUG

MediCane's medical cannabis oil

MediCane's medical cannabis oil

Placebo Oil DRUG

Placebo Oil

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• M. H MediCane Ltd.: lead

Study Sites (3)

Laniado Hospital

Netanya, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Tel-Aviv Sourasky Medical Center Ichilov

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Psychomotor Agitation; Problem Behavior; Dementia; Alzheimer Disease

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Child Behavior; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Neta Rimmerman, PhD

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: January 22, 2024
• Study Start: October 12, 2022
• Primary Completion: March 10, 2024
• Study Completion: March 10, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)