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

Alzheimer Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06217146
• Other study ID #: AGM-01
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: October 12, 2025

Study information

• Verified date: January 2024
• Source: M. H MediCane Ltd.
• Contact: Neta Rimmerman, PhD
• Phone: +972549929445
• Email: neta.rimmerman[@]medicane.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 12, 2025
• Est. primary completion date: October 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Alzheimer Disease
• Dementia
• Disruptive Behavior
• Problem Behavior
• Psychomotor Agitation

Intervention

Drug:
• Medical Cannabis
MediCane's balanced T3:C3 medical cannabis oil
• Placebo Oil
Placebo Oil

Locations

Country	Name	City	State
Israel	Laniado Hospital	Netanya
Israel	Sheba Medical Center	Ramat-Gan
Israel	Tel-Aviv Sourasky Medical Center Ichilov	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
M. H MediCane Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 Safety (Adverse Events)	Number of participants with treatment-related adverse events as assessed by severity. protocol.	Up to 22 weeks
Primary	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