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

A Two-part Study, Part I an Open-label; and Part II a Randomized Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MediCane's Balanced T3:C3 Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia Including Probable Alzheimer's Disease (AD)

This double-blind, placebo-controlled study is designed to assess the effectiveness of, MediCane's balanced T3:C3 oil, a medical cannabis oil extracted from MediCane's balanced 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.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Alzheimer Disease; Agitation,Psychomotor; Disruptive Behavior
• Intervention / Treatment: Drug: Medical Cannabis; Drug: Placebo Oil

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neta Rimmerman, PhD; Phone Number: +972549929445; Email: neta.rimmerman@medicane.net

Study Locations

• Israel
  • Netanya, Israel
    • Recruiting
    • Laniado Hospital
    • Contact: Hermush, MD
    • Principal Investigator: Hermush, MD
  • Ramat-Gan, Israel
    • Recruiting
    • Sheba Medical Center
    • Contact: Ravona-Springer
    • Principal Investigator: Ravona-Springer, MD
  • Tel Aviv, Israel
    • Recruiting
    • Tel-Aviv Sourasky Medical Center Ichilov
    • Contact: Bregman, MD
    • Principal Investigator: Bregman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Oil; Placebo Oil
Experimental: MediCane's balanced T3:C3 medical cannabis oil	Drug: Medical Cannabis; MediCane's balanced T3:C3 medical cannabis oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: M. H MediCane Ltd.
• Investigators: Study Director: Neta Rimmerman, PhD, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Estimated): October 12, 2025
• Study Completion (Estimated): October 12, 2025

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Dyskinesias; Psychomotor Disorders; Tauopathies; Problem Behavior; Psychomotor Agitation; Dementia; Alzheimer Disease
• Other Study ID Numbers: AGM-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No