๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-18

Clinical Trial on Agitation in Alzheimer's Dementia (NCT05543681)

A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Trial of the Safety and Efficacy of IGC-AD1 on Agitation in Participants With Dementia Due to Alzheimer's Disease

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: IGC Pharma, LLC

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: ClinCloud, LLC โ€” Maitland, Florida

Age range: 60 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (31 Sites)

Showing the first 25 of 31 sites.

  • ClinCloud, LLC โ€” Maitland, Florida
  • ClinCloud, LLC โ€” Melbourne, Florida
  • Central Miami Medical Institute โ€” Miami, Florida
  • Visionary Investigators Network โ€” Miami, Florida
  • Miami Jewish Health โ€” Miami, Florida
  • Neurostudies Inc. โ€” Port Charlotte, Florida
  • BayCare Health System Inc. โ€” St. Petersburg, Florida
  • University of South Florida Department of Psychiatry and Behavioral Neurosciences โ€” Tampa, Florida
  • Tandem Clinical Research GI, LLC โ€” Metairie, Louisiana
  • MedStar Franklin Square Medical Center Neurology โ€” Baltimore, Maryland
  • Medstar Southern Maryland Hospital Center โ€” Clinton, Maryland
  • Medstar Montgomery Medical Center โ€” Olney, Maryland
  • Tekton Research LLC โ€” St Louis, Missouri
  • Dent Neurologic Institute โ€” Amherst, New York
  • Integrative Clinical Trials, LLC โ€” Brooklyn, New York
  • Icahn School of Medicine at Mount Sinai โ€” New York, New York
  • Ichor Research โ€” Syracuse, New York
  • Lynn Health Science Institute (LHSI) โ€” Oklahoma City, Oklahoma
  • Butler Hospital, Brown University โ€” Providence, Rhode Island
  • Senior Adults Specialty Research โ€” Austin, Texas
  • Baylor Scott and White Research Institute โ€” Dallas, Texas
  • Kerwin Medical Center โ€” Dallas, Texas
  • Dominion Medical Associates, Inc. โ€” Richmond, Virginia
  • Island Health Authorities โ€” Victoria, British Columbia
  • Hamilton Health Sciences , Mcmaster University โ€” Hamilton, Ontario

๐Ÿ“ž Contact the Study Coordinator

Phone: (301) 339-4270

Email: calma@igcpharma.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—