Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

Clinical Trial on Agitation in Alzheimer's Dementia

NCT05543681 · View on ClinicalTrials.gov ↗

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.

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

Interested in This Trial?

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IGC Pharma, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05543681 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, Maryland, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05543681?

The interventions under investigation include: IGC-AD1-Active (DRUG), IGC-AD1-Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05543681?

This trial is sponsored by IGC Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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