Overview: CALMA is a multicenter Phase 2 clinical trial designed to evaluate the safety and efficacy of IGC-AD1 for treating agitation associated with Alzheimer’s dementia. The purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from Alzheimer’s.

 

ClinicalTrials.gov Identifier: NCT 05543681
https://clinicaltrials.gov/study/NCT05543681
Study Type: Interventional (Clinical Trial)
Participants(n): 164
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (ParticipantCare ProviderInvestigator)
Primary Purpose: Treatment
Intervention Description: The investigational medication is an oral solution containing two active ingredients: delta-9 tetrahydrocannabinol (THC) and melatonin. The treatment is administered for 42 days, followed by a two-day taper period at the end of the study.

Drug: IGC-AD1-Active

A non-sterile solution for oral administration.

 

Primary Outcome Agitation

Change in mean Cohen Mansfield Agitation Inventory (CMAI) score. Assess the efficacy of IGC-AD1 on agitation at Week 6.

Secondary Outcome

Acute Agitation

Assess the efficacy of IGC-AD1 on agitation at Week 2.

 

Funded by: CIHR