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NCT05543681 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial on Agitation in Alzheimer's Dementia
A Phase 2 study of Alzheimer Disease and Aggression, sponsored by IGC Pharma.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 164
- Enrollment target
- 20
- Study locations
NCT05543681: Recruiting Phase 2 study of Alzheimer Disease and Aggression, sponsored by IGC Pharma.
NCT05543681 is a Phase 2 study of Alzheimer Disease and Aggression that is actively recruiting participants, run by IGC Pharma. The registered enrollment target is 164 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05543681, a Phase 2 study of Alzheimer Disease and Aggression, is actively recruiting participants, sponsored by IGC Pharma.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 164 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Change in mean Cohen Mansfield Agitation Inventory (CMAI) score
Conditions Studied
Interventions
- DRUG IGC-AD1-Active
- DRUG IGC-AD1-Placebo
Study Locations (20)
Florida
- ClinCloud, LLC - Maitland
- ClinCloud, LLC - Melbourne
- Global Medical Institutes Florida, LLC - Miami
- Visionary Investigators Network - Miami
- Miami Jewish Health - Miami
- Neurostudies Inc. - Port Charlotte
- BayCare Health System Inc. - St. Petersburg
- University of South Florida Department of Psychiatry and Behavioral Neurosciences - Tampa
Maryland
- MedStar Franklin Square Medical Center Neurology - Baltimore
- Medstar Georgetown University Hospital Neurology - Clinton
- Medstar Montgomery Medical Center - Olney
New York
- Dent Neurosciences Research Center - Amherst
- Integrative Clinical Trials, LLC - Brooklyn
- Ichor Research - Syracuse
Louisiana
- Tandem Intermediate, LLC - Metairie
Missouri
- Tekton Research LLC - St Louis
Oklahoma
- Lynn Health Science Institute (LHSI) - Oklahoma City
Rhode Island
- Butler Hospital, Brown University - Providence
Texas
- Senior Adults Specialty Research - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2022-10-11 |
| Est. Completion | 2026-03-30 |
| Phase | Phase 2 |
What NCT05543681 shows while recruiting
NCT05543681 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which IGC-AD1-Active is the first listed.
NCT05543681 names 20 study sites across 9 states, led by Florida, Maryland, New York.
Frequently Asked Questions
What is clinical trial NCT05543681 about?
NCT05543681 is a clinical study titled "Clinical Trial on Agitation in 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.
What is the current status of trial NCT05543681?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2022-10-11. Estimated completion is 2026-03-30.
What conditions does trial NCT05543681 study?
This clinical trial studies the following conditions: Alzheimer Disease, Aggression, Agitation,Psychomotor, Care Giving Burden, NPS.
What interventions are being tested in trial NCT05543681?
The interventions under investigation include: IGC-AD1-Active (DRUG), IGC-AD1-Placebo (DRUG).
Who is sponsoring clinical trial NCT05543681?
This trial is sponsored by IGC Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05543681 being conducted?
This trial has 20 study locations across Florida, Louisiana, Maryland, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05543681's enrollment target sits among peer trials
164 122nd of 306 higher than 184 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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