This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 150 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 12 week optional open-label extension will be offered to participants who complete the double-blind period.
Agitation, Dementia
This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 150 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 12 week optional open-label extension will be offered to participants who complete the double-blind period.
Life's End Benefits of cannaBidiol and tetrahYdrocannabinol
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Sun Valley Research Center, Imperial, California, United States, 92251
The Neuron Clinic, San Marcos, California, United States, 92069
Georgetown University, Washington, District of Columbia, United States, 20007
Howard University, Washington, District of Columbia, United States, 20059
Galiz Research, Hialeah, Florida, United States, 33016
Melgar-Caro Medcenter and Community Research (MCMCR), Miami, Florida, United States, 33145
University of South Florida, Tampa, Florida, United States, 33612
University of Kentucky, Lexington, Kentucky, United States, 40504
Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States, 70808
University of Maryland, Baltimore, Maryland, United States, 21201
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.
40 Years to
ALL
No
University of Southern California,
Paul Aisen, MD, STUDY_DIRECTOR, Alzheimer's Therapeutic Research Institute
Jacobo Mintzer, MD, PRINCIPAL_INVESTIGATOR, Ralph H. Johnson Veterans Affairs Medical Center (VAMC)
Brigid Reynolds, NP, PRINCIPAL_INVESTIGATOR, Georgetown University
2025-12