TerminatedPhase NA

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 Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia Including Probable Alzheimer's Disease (AD)

Lead sponsor

M. H MediCane Ltd.

Asset

Medical Cannabis

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 24

Primary endpoints

•Part 1 Safety (Adverse Events)•Part 2 Efficacy (CMAI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAGM-01

NCT IDNCT06217146

Timeline

Milestones

Study start2022-10-12actual

Study first posted2024-01-22actual

Primary completion2024-03-10actual

Study completion2024-03-10actual

Last update posted2024-06-27actual

Assets

Drug assets

Medical Cannabis

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Safety / tolerability / PK

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Part 2 Efficacy (CMAI)

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Part 1 Efficacy (NPI-12)

Time frame:up to 18 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Part 1 Safety (Adverse Events)

Time frame:Up to 22 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.