Clinical Trial on Agitation in Alzheimer's Dementia (CALMA)

Description

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

Alzheimer Disease, Agitation,Psychomotor, Depression, Anxiety, Memory Impairment, Care Giving Burden, NPS, Agitated; State, Acute Reaction to Stress, Aggression, Aggressive Outburst

Study Overview

Study Details

Study overview

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.

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

Clinical Trial on Agitation in Alzheimer's Dementia (CALMA)

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

Maitland

ClinCloud, LLC, Maitland, Florida, United States, 32751

Melbourne

ClinCloud, LLC, Melbourne, Florida, United States, 32940

Miami

Global Medical Institutes Florida, LLC, Miami, Florida, United States, 33125

Port Charlotte

Neurostudies Inc., Port Charlotte, Florida, United States, 33952

Saint Petersburg

BayCare Health System Inc., Saint Petersburg, Florida, United States, 33705

Baltimore

MedStar Franklin Square Medical Center Neurology, Baltimore, Maryland, United States, 21237

Clinton

Medstar Georgetown University Hospital Neurology, Clinton, Maryland, United States, 20735

Olney

Medstar Montgomery Medical Center, Olney, Maryland, United States, 20832

Newton

Site 800, Newton, Massachusetts, United States, 02459

Amherst

Dent Neurosciences Research Center, Amherst, New York, United States, 02459

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    60 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    IGC Pharma, LLC,

    Dr. Saadia Shahnawaz, MD, STUDY_DIRECTOR, IGC Pharma, LLC

    Study Record Dates

    2025-06-30