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.

NCT05543681

Clinical Trial on Agitation in Alzheimer's Dementia

Recruiting
PHASE2Ages 60+InterventionalTreatment
IGC Pharma, LLC
~164 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:IGC-AD1-ActiveIGC-AD1-Placebo

At a glance

Recruiting sites
28 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Agitation
Measured over Baseline to week six
Alzheimer Disease
Agitation,Psychomotor
Care Giving Burden
NPS
Aggression
31 sites across 15 states
Florida8
New York4
Maryland3
Texas3
Ontario2
Puerto Rico2
Louisiana1
Missouri1

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  • AgitationBaseline to week six

    Change in mean Cohen Mansfield Agitation Inventory (CMAI) score