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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 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.

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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.

Conditions Studied

Alzheimer Disease Aggression Agitation,Psychomotor Care Giving Burden NPS

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

FieldValue
Enrollment Target 164 participants
Start Date 2022-10-11
Est. Completion 2026-03-30
Phase Phase 2

Sponsor

IGC Pharma

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05543681

The ClinicalTrials.gov registry entry for NCT05543681 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (94% lower). The listed sponsor is IGC Pharma, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.