MedTrace Logo

Clinical Trial on Agitation in Alzheimer's Dementia

NCT05543681 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-05-20

No results posted yet for this 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

Interventions

DRUG

IGC-AD1-Active

A non-sterile solution for oral administration.

DRUG

IGC-AD1-Placebo

A non-sterile solution for oral administration similar in color and texture to the Active.

Sponsors & Collaborators

  • IGC Pharma, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Colombia
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543681 on ClinicalTrials.gov