Life's End Benefits of cannaBidiol and tetrahYdrocannabinol

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 18, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
AgitationDementia
Interventions
DRUG

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))."

DRUG

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))."

Trial Locations (11)

20007

RECRUITING

Georgetown University, Washington D.C.

20059

RECRUITING

Howard University, Washington D.C.

21201

RECRUITING

University of Maryland, Baltimore

29401

RECRUITING

Ralph H. Johnson VA Medical Center, Charleston

33145

RECRUITING

Melgar-Caro Medcenter and Community Research (MCMCR), Miami

33612

RECRUITING

University of South Florida, Tampa

37212

RECRUITING

Vanderbilt University Medical Center Center for Cognitive Medicine, Nashville

40504

RECRUITING

University of Kentucky, Lexington

44122

RECRUITING

Case Western Reserve University, Beachwood

70808

RECRUITING

Pennington Biomedical Research Center, Baton Rouge

92251

RECRUITING

Sun Valley Research Center, Imperial

All Listed Sponsors
collaborator

Medical University of South Carolina

OTHER

collaborator

Alzheimer's Clinical Trials Consortium

OTHER

collaborator

Alzheimer's Therapeutic Research Institute

OTHER

collaborator

National Institute on Aging (NIA)

NIH

lead

University of Southern California

OTHER

NCT05644262 - Life's End Benefits of cannaBidiol and tetrahYdrocannabinol | Biotech Hunter | Biotech Hunter