TerminatedNot Applicable

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

Stopped: Part I: Open-label was completed.

Israel24 participantsStarted 2022-10-12

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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Exclusion criteria

✕. 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.

What they're measuring

Part 1 Safety (Adverse Events)

Timeframe: Up to 22 weeks

Part 2 Efficacy (CMAI)

Timeframe: 12 weeks

Trial details

NCT IDNCT06217146

SponsorM. H MediCane Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-10

View on ClinicalTrials.gov More Agitation,Psychomotor trials