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CBD + THC for Agitation in Dementia (LiBBY Trial)
LiBBY Trial Summary
This trial tests if an oral combination of THC/CBD will reduce agitation in hospice-eligible dementia patients. 150 participants will be randomized to either active drug or placebo over 12 weeks, with an optional 24 week follow-up.
LiBBY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLiBBY Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LiBBY Trial Design
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Who is running the clinical trial?
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- I am not allergic to cannabinoids or oils like coconut or sesame oil.My condition is at stage 6d of the FAST scale.You are showing signs of strong restlessness or nervousness during the screening test.I agree not to use any form of cannabinoids except the trial medication for the first 12 weeks.You are currently receiving care from hospice at home or in a hospital.You have been diagnosed with a major neurocognitive disorder according to the DSM-V criteria.I am 40 years old or older.I can take medicine in liquid form.You have used marijuana or products containing cannabinoids in the three weeks before the start of the study, as reported by yourself.You have a score of 12 or more on the Advanced Dementia Prognostic Tool (ADEPT) as measured by the Mitchell Index.
- Group 1: T2:C100
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the Federal Drug Administration given its stamp of approval to T2:C100?
"Although yet to be fully validated, there is evidence backing the safety of T2:C100 which led our team at Power to assign it a score of 2."
How many venues are involved in the management of this trial?
"This research is taking place in University of Pittsburgh, Ralph H. Johnson VA Medical Center and the University of Kentucky among 8 other areas. These locations are located in Pennsylvania, South carolina, and Kentucky respectively."
Are researchers currently gathering participants for this experiment?
"Clinicaltrials.gov confirms that this trial is not currently recruiting, with the initial posting on January 1st 2023 and last update from November 30th 2022. Nevertheless, there are over 400 different studies welcoming participants at this moment in time."
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