Status:
TERMINATED
A Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia.
Lead Sponsor:
M. H MediCane Ltd.
Conditions:
Agitation,Psychomotor
Disruptive Behavior
Eligibility:
All Genders
50+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
- Subjects with a history of addiction or drug abuse.
Key Trial Info
Start Date :
October 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06217146
Start Date
October 12 2022
End Date
March 10 2024
Last Update
June 27 2024
Active Locations (3)
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1
Laniado Hospital
Netanya, Israel
2
Sheba Medical Center
Ramat Gan, Israel
3
Tel-Aviv Sourasky Medical Center Ichilov
Tel Aviv, Israel