120
Participants
Start Date
December 18, 2023
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
T2:C100
"The active study intervention, T2:C100, is an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) in a digestible oil. T2:C100 is a full spectrum oral solution with five non-reactive ingredients: delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), a pharmaceutical grade medium chain triglyceride (MCT) oil, and two flavoring agents (lemon and peppermint).~During the double-blind treatment period, participants will receive 1mL study drug (T2:C100) twice daily for Baseline - Day 7 (approximately 1 week), and then will increase to 2mL study drug twice for the remainder of the double-blind treatment period (Day 7 - Week 12 (approximately 11 weeks)).~Participants who enter the Open Label Extension will receive 1mL study drug (T2:C100) twice daily for Week 12 - Week 13 (approximately 1 week), and will then increase to 2mL study drug twice daily for the remainder of the Open Label Extension (Week 13 - Week 26 (approximately 23 weeks))."
Placebo
"Matching placebo in a digestible oil. The placebo contains only three non-reactive ingredients: medium chain triglyceride (MCT) oil and two flavoring agents (lemon and peppermint).~During the double-blind treatment period, participants will receive 1mL placebo twice daily for Baseline - Day 7 (approximately 1 week), and then will increase to 2mL placebo twice for the remainder of the double-blind treatment period (Day 7 - Week 12 (approximately 11 weeks))."
RECRUITING
Georgetown University, Washington D.C.
RECRUITING
Howard University, Washington D.C.
RECRUITING
University of Maryland, Baltimore
RECRUITING
Ralph H. Johnson VA Medical Center, Charleston
RECRUITING
Melgar-Caro Medcenter and Community Research (MCMCR), Miami
RECRUITING
University of South Florida, Tampa
RECRUITING
Vanderbilt University Medical Center Center for Cognitive Medicine, Nashville
RECRUITING
University of Kentucky, Lexington
RECRUITING
Case Western Reserve University, Beachwood
RECRUITING
Pennington Biomedical Research Center, Baton Rouge
RECRUITING
Sun Valley Research Center, Imperial
Collaborators (1)
Medical University of South Carolina
OTHER
Alzheimer's Clinical Trials Consortium
OTHER
Alzheimer's Therapeutic Research Institute
OTHER
National Institute on Aging (NIA)
NIH
University of Southern California
OTHER