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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: Active Phase 2 study of Dementia and Agitation, sponsored by University of Southern California.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Cohen-Mansfield Agitation Inventory (CMAI) assesses the average frequency of manifestations of agitated behaviors in elderly persons over a 1-week period. The CMAI is a questionnaire consisting of 29 agitated behaviors, each rated on a 7-point frequency scale. In addition to the frequency of each behavior, informants/caregivers will be asked to use a 5-point scale to rate the disruptiveness of each behavior. For this study, the CMAI will target behaviors observed by knowledgeable informants/
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 |
What the registry record for NCT05644262 still lists
NCT05644262 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 7,722-participant average among 199 other Dementia trials with a reported enrollment target (98% lower).
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 lists 10 locations in 8 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05644262's enrollment target sits among peer trials
120 108th of 199 higher than 88 of 199 other Dementia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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