Clinical Trial on Agitation in Alzheimer's Dementia
This study is testing an oral medication called IGC-AD1 to see if it can help reduce agitation in people with Alzheimer's dementia. IGC-AD1 contains THC (delta-9-tetrahydrocannabinol) and melatonin. You might be able to join if you are 60 or older, have mild to severe Alzheimer's dementia, and have experienced agitation for at least two weeks. The study will measure changes in agitation levels over six weeks to see how well IGC-AD1 works. The goal is to find out if this medication can make a difference for those experiencing agitation.
- Study design
- This is a multi-center, double-blind (neither you nor your doctor will know if you're getting the active drug or a placebo), randomized (you're assigned to a group by chance), placebo-controlled study with 164 planned participants.
- What's involved
- You would take an oral solution twice a day for 42 days, followed by a two-day tapering period. There will be daily safety calls initially, then every three days, to review logbook entries and any changes in medications or side effects.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measure of the study's success is taken at the end of treatment, which is after 42 days of medication and a two-day taper.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Clinical Trial on Agitation in Alzheimer's Dementia
At a glance
Conditions
Where it's being run
31 sites across 15 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- AgitationBaseline to week six
Change in mean Cohen Mansfield Agitation Inventory (CMAI) score