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Cannabinoid
CBD + THC for Agitation in Dementia (LiBBY Trial)
Phase 2
Recruiting
Led By Jacobo Mintzer, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage 6d on the Functional Assessment Staging Test (FAST)
Ability to take or be administered liquid medication
Must not have
Suspected or known allergic reactions, adverse reactions, or hypersensitivity to cannabinoids and/or components (e.g., (<specify oil to be used in final formulation, e.g.: coconut oil; sesame oil>) of the study drug (T2:C100 or placebo)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 7, day 14, week 4, week 8 and week 12
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.
Who is the study for?
This trial is for hospice care-eligible patients aged 40 or older with dementia and significant agitation. They must not use other cannabinoids during the study, be able to take liquid medication, have a caregiver to help with the study requirements, and meet specific clinical criteria.
What is being tested?
The trial tests an oral mix of THC/CBD against a placebo over 12 weeks to see if it reduces agitation in dementia patients. Participants are randomly assigned to either the drug or placebo group in equal numbers.
What are the potential side effects?
Potential side effects may include typical reactions associated with THC/CBD such as drowsiness, dry mouth, changes in appetite or mood, dizziness, and possibly allergic reactions to ingredients in the formulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is at stage 6d of the FAST scale.
Select...
I can take medicine in liquid form.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not allergic to cannabinoids or oils like coconut or sesame oil.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 7, day 14, week 4, week 8 and week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 7, day 14, week 4, week 8 and week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 2 weeks
Secondary study objectives
Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 12 weeks
Clinical Global Impression of Change - agitation (CGICa)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: T2:C100Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,182 Total Patients Enrolled
292 Trials studying Dementia
23,634,329 Patients Enrolled for Dementia
University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,495 Total Patients Enrolled
13 Trials studying Dementia
252,411 Patients Enrolled for Dementia
Medical University of South CarolinaOTHER
974 Previous Clinical Trials
7,399,249 Total Patients Enrolled
4 Trials studying Dementia
245 Patients Enrolled for Dementia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: T2:C100
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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