Actively Recruiting
Phase 2 Study of Oral IGC-AD1 THC and Melatonin for Treating Agitation in People 60 and Older With Alzheimers Dementia
Led by IGC Pharma, LLC · Updated on 2026-05-20
164
Participants Needed
31
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the effects of IGC-AD1, an oral medication containing THC and melatonin, on agitation in patients aged 60 and older with mild to severe Alzheimers dementia. The study is a multi-center, double-blind, randomized, placebo-controlled clinical trial aiming to assess how IGC-AD1 impacts agitation symptoms compared to a placebo. Participants must have clinically significant agitation lasting at least two weeks and meet specific criteria to ensure the agitation is related to Alzheimers dementia. Participants will receive either the active oral solution of IGC-AD1 or a placebo, both administered twice daily for 42 days followed by a two-day dose taper. The study includes safety monitoring with frequent phone calls to review medication use, adverse events, and study partner logbook entries. Blood samples will be taken during the trial to analyze drug levels, brain-related biomarkers, and genetic factors. During the study, participants and their caregivers will complete various assessments, including the Cohen-Mansfield Agitation Inventory CMAI to measure changes in agitation over six weeks and at two weeks. Safety and medication adherence will be closely monitored. The total participation time includes the treatment period and follow-up safety calls. Researchers will also evaluate secondary and exploratory outcomes related to agitation and collect pharmacokinetic data.
CONDITIONS
Brief Title
Clinical Trial on Agitation in Alzheimer's Dementia
Research Team
E
Evelyn Gutiérrez
M
Margarita Venegas
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