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NCT05644262 · ClinicalTrials.gov registry record · Phase 2
Life's End Benefits of cannaBidiol and tetrahYdrocannabinol
A Phase 2 study of Dementia and Agitation, sponsored by University of Southern California.
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 10
- Study locations
NCT05644262 is a Phase 2 study of Dementia and Agitation that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 120 participants, below the 7,722-participant average among 199 other Dementia trials with a reported enrollment target (98% lower). The trial reports 10 study locations across 8 states.
The verdict
NCT05644262, a Phase 2 study of Dementia and Agitation, is active but no longer recruiting, sponsored by University of Southern California.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 10
- Study locations
Study Summary
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 120 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.
Interventions
- DRUG Placebo
- DRUG T2:C100
Study Locations (10)
District of Columbia
- Georgetown University - Washington D.C.
- Howard University - Washington D.C.
Florida
- Melgar-Caro Medcenter and Community Research (MCMCR) - Miami
- University of South Florida - Tampa
Kentucky
- University of Kentucky - Lexington
Louisiana
- Pennington Biomedical Research Center - Baton Rouge
Maryland
- University of Maryland - Baltimore
Ohio
- Case Western Reserve University - Beachwood
South Carolina
- Ralph H. Johnson VA Medical Center - Charleston
Tennessee
- Vanderbilt University Medical Center Center for Cognitive Medicine - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-12-18 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05644262
The ClinicalTrials.gov registry entry for NCT05644262 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,722-participant average among 199 other Dementia trials with a reported enrollment target (98% lower). The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Dementia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05644262 reports 10 study locations spanning 8 distinct geographic areas - top geographies include District of Columbia, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT05644262 about?
NCT05644262 is a clinical study titled "Life's End Benefits of cannaBidiol and tetrahYdrocannabinol". 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 ag...
What is the current status of trial NCT05644262?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2023-12-18. Estimated completion is 2026-03.
What conditions does trial NCT05644262 study?
This clinical trial studies the following conditions: Dementia, Agitation.
What interventions are being tested in trial NCT05644262?
The interventions under investigation include: Placebo (DRUG), T2:C100 (DRUG).
Who is sponsoring clinical trial NCT05644262?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05644262 being conducted?
This trial has 10 study locations across District of Columbia, Florida, Kentucky, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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