RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-10-11
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05543681

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.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Evelyn Gutiérrez
CONTACT
3013394270
calma@igcpharma.com
Margarita Venegas
CONTACT
mvenegas@igcpharma.com

Principal Investigator

Dr. Saadia Shahnawaz, MD
STUDY_DIRECTOR
IGC Pharma, LLC

Study Locations (Sites)

ClinCloud, LLC
Maitland, Florida, 32751
United States
ClinCloud, LLC
Melbourne, Florida, 32940
United States
Global Medical Institutes Florida, LLC
Miami, Florida, 33125
United States
Neurostudies Inc.
Port Charlotte, Florida, 33952
United States
BayCare Health System Inc.
Saint Petersburg, Florida, 33705
United States
MedStar Franklin Square Medical Center Neurology
Baltimore, Maryland, 21237
United States
Medstar Georgetown University Hospital Neurology
Clinton, Maryland, 20735
United States
Medstar Montgomery Medical Center
Olney, Maryland, 20832
United States
Site 800
Newton, Massachusetts, 02459
United States
Dent Neurosciences Research Center
Amherst, New York, 02459
United States
Lynn Health Science Institute (LHSI)
Oklahoma City, Oklahoma, 73112
United States
Senior Adults Specialty Research
Austin, Texas, 78757
United States

Collaborators and Investigators

Sponsor: IGC Pharma, LLC

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-11
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-10-11
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Cannabis
  • Tetrahydrocannabinol
  • THC
  • Melatonin
  • Alzheimer's
  • Marijuana
  • Hemp
  • Agitation
  • Dementia
  • Depression
  • Anxiety
  • Memory
  • NPI
  • CMAI
  • Dronabinol

Additional Relevant MeSH Terms

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