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Active, not recruiting Phase 2 Interventional

Clinical Trial on Agitation in Alzheimer's Dementia

ClinicalTrials.gov ID: NCT05543681

Public ClinicalTrials.gov record NCT05543681. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 6:19 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05543681
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
IGC Pharma, LLC
Industry
Enrollment
164 participants

Conditions and interventions

Eligibility (public fields only)

Age range
60 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 11, 2022 (Actual)
Primary completion
Nov 2026 (Estimated)
Completion
Nov 2026 (Estimated)
Last update posted
Sep 30, 2026

2022 – 2026

United States locations

U.S. sites
21
U.S. states
9
U.S. cities
18
Facility City State ZIP Site status
ClinCloud, LLC Maitland Florida 32751 —
ClinCloud, LLC Melbourne Florida 32940 —
Central Miami Medical Institute Miami Florida 33125 —
Visionary Investigators Network Miami Florida 33133 —
Miami Jewish Health Miami Florida 33137 —
Neurostudies Inc. Port Charlotte Florida 33952 —
University of South Florida Department of Psychiatry and Behavioral Neurosciences Tampa Florida 33613 —
Tandem Clinical Research GI, LLC Metairie Louisiana 70006 —
MedStar Franklin Square Medical Center Neurology Baltimore Maryland 21237 —
Medstar Southern Maryland Hospital Center Clinton Maryland 20735 —
Medstar Montgomery Medical Center Olney Maryland 20832 —
Tekton Research LLC St Louis Missouri 63128 —
Dent Neurologic Institute Amherst New York 02459 —
Integrative Clinical Trials, LLC Brooklyn New York 11229 —
Ichor Research Syracuse New York 13210 —
Lynn Health Science Institute (LHSI) Oklahoma City Oklahoma 73112 —
Butler Hospital, Brown University Providence Rhode Island 02906 —
Senior Adults Specialty Research Austin Texas 78757 —
Baylor Scott and White Research Institute Dallas Texas 75231 —
Kerwin Medical Center Dallas Texas 75231 —
Dominion Medical Associates, Inc. Richmond Virginia 23219 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05543681, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 30, 2026 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05543681 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →