RecruitingPhase 2NCT05543681

Clinical Trial on Agitation in Alzheimer's Dementia

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

Sponsor

IGC Pharma, LLC

Enrollment

164 participants

Start Date

Oct 11, 2022

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease Aggression Agitation,Psychomotor Care Giving Burden NPS

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.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is testing a treatment for agitation in people with Alzheimer's dementia — one of the most distressing symptoms of the disease, which causes significant stress for both patients and caregivers. Researchers are testing an investigational drug to see if it can safely and effectively reduce agitation without causing excessive sedation. **You may be eligible if:** - You have been diagnosed with Alzheimer's dementia - You experience significant agitation (as assessed by your doctor) - You have a caregiver who is willing and able to participate in all study activities, including home monitoring and video check-ins - Your caregiver has a smartphone or computer and can learn basic monitoring tasks (blood pressure, weight) **You may NOT be eligible if:** - You do not have a caregiver who can participate - You have certain serious medical conditions that make the study treatment unsafe - You are on certain medications that would interact with the study drug - Your caregiver is unable or unwilling to use electronic devices for remote monitoring Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIGC-AD1-Active

A non-sterile solution for oral administration.

DRUGIGC-AD1-Placebo

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

Locations(30)

ClinCloud, LLC

Maitland, Florida, United States

ClinCloud, LLC

Melbourne, Florida, United States

Central Miami Medical Institute

Miami, Florida, United States

Visionary Investigators Network

Miami, Florida, United States

Miami Jewish Health

Miami, Florida, United States

Neurostudies Inc.

Port Charlotte, Florida, United States

BayCare Health System Inc.

St. Petersburg, Florida, United States

University of South Florida Department of Psychiatry and Behavioral Neurosciences

Tampa, Florida, United States

Tandem Clinical Research GI, LLC

Metaire, Louisiana, United States

MedStar Franklin Square Medical Center Neurology

Baltimore, Maryland, United States

Medstar Southern Maryland Hospital Center

Clinton, Maryland, United States

Medstar Montgomery Medical Center

Olney, Maryland, United States

Tekton Research LLC

St Louis, Missouri, United States

Dent Neurologic Institute

Amherst, New York, United States

Integrative Clinical Trials, LLC

Brooklyn, New York, United States

Ichor Research

Syracuse, New York, United States

Lynn Health Science Institute (LHSI)

Oklahoma City, Oklahoma, United States

Butler Hospital, Brown University

Providence, Rhode Island, United States

Senior Adults Specialty Research

Austin, Texas, United States

Baylor Scott and White Research Institute

Dallas, Texas, United States

Kerwin Medical Center

Dallas, Texas, United States

Dominion Medical Associates, Inc.

Richmond, Virginia, United States

Island Health Authorities

Victoria, British Columbia, Canada

Hamilton Health Sciences , Mcmaster University

Hamilton, Ontario, Canada

Baycrest Academy for Research and Education , University of Toronto

Toronto, Ontario, Canada

Douglas Hospital Research Center, McGill university

Montreal, Quebec, Canada

Grupo de Neurociencias de Antioquia, Universidad de Antioquia

Medellín, Antioquia, Colombia

Instituto Sanacoop

Bayamón, Bayamón, Puerto Rico

SCB Research Center Corp

Bayamón, Puerto Rico, Puerto Rico

The Alliance, Medical Sciences Campus University of Puerto Rico

Rio Piedras, Puerto Rico, Puerto Rico

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05543681

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