A Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia.
- Conditions
- Disruptive BehaviorAlzheimer DiseaseDementiaAgitation,Psychomotor
- Interventions
- Drug: Placebo Oil
- Registration Number
- NCT06217146
- Lead Sponsor
- M. H MediCane Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
- 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.
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Subject without a legal guardian.
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Subject with any current unstable medical condition.
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Subject has any unstable condition involving fluid retention, pulmonary infiltrates, congestive heart failure, respiratory symptoms or disease, or cardiac symptoms or disease.
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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.
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Subject has epilepsy.
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Subject has a history of hypersensitivity to any cannabinoid.
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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).
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Subject suffering from delirium as defined in Appendix B - Criteria for Delirium.
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Current inpatient hospitalization.
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Subject has other health-related factors that could explain behavioral disturbances (electrolyte disturbances, infectious diseases, etc.).
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Subject has a satisfactory response to antipsychotic treatments.
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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.
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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.
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Subjects with a history of addiction or drug abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oil - MediCane's medical cannabis oil Medical Cannabis -
- Primary Outcome Measures
Name Time Method Part 2 Efficacy (CMAI) 12 weeks 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.
Part 1 Safety (Adverse Events) Up to 22 weeks Number of participants with treatment-related adverse events as assessed by severity. protocol.
- Secondary Outcome Measures
Name Time Method Part 1 Efficacy (NPI-12) up to 18 weeks Change in neuropsychiatric symptoms measured by the total score and subscores of the NPI-12.
Trial Locations
- Locations (3)
Laniado Hospital
🇮🇱Netanya, Israel
Sheba Medical Center
🇮🇱Ramat-Gan, Israel
Tel-Aviv Sourasky Medical Center Ichilov
🇮🇱Tel Aviv, Israel