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Overview: CALMA is a multicenter Phase 2 clinical trial designed to evaluate the safety and efficacy of IGC-AD1, a medication for treating agitation associated with Alzheimer’s dementia. IGC-AD1, is a cannabis -based (Delta-9 Tetrahydrocannabinol [THC]) formulation to treat agitation in patients with mild to severe dementia due to Alzheimer’s disease. The medication is given twice daily for 6 weeks.
| 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.
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| 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 AgitationAssess the efficacy of IGC-AD1 on agitation at Week 2.
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Funded by: CIHR
