Dronabinol
All participants will take both dronabinol and placebo at different points in the study in this crossover design trial.
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The goal of this clinical trial is to study the effects of dronabinol in US Veterans with agitation related to moderate to severe dementia. The main goals of the study are: * To evaluate the efficacy of dronabinol for the treatment of agitation in moderate to severe dementia compared to placebo * To evaluate the safety of dronabinol in the treatment of agitation in moderate to severe dementia compared to placebo Fifty (50) subjects will be given either dronabinol or placebo for 8 weeks. All subjects will then undergo a "washout" phase for 3 weeks, followed by the crossover intervention (i.e. subjects who received placebo during the first phase will receive dronabinol during the second phase, and vice versa). Thus, all participants will be taking dronabinol at some point during the study. During the study, subjects will undergo evaluations for: * Agitation * Cognitive changes * Physical changes (i.e. labs, ekg, physical exam)
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2024-07-05
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
The investigators will conduct a phase IIa study to evaluate the efficacy and safety of dronabinol in the treatment of agitation related to dementia in the US Veteran population. Specific Aim 1 - To evaluate the efficacy of dronabinol (target dose 5 mg bid) for the treatment of agitation in dementia. Hypothesis: Dronabinol improves clinically significant agitation in moderate to severe dementia. Approach: The investigators will conduct a 6-week, double-blind, placebo-controlled, crossover, exploratory study of 50 Veterans suffering from moderate to severe dementia and clinically significant agitation with the Cohen Mansfield Agitation Inventory (CMAI) total score as the main outcome measure. Impact: The potential benefit of dronabinol in agitation will be evaluated. Specific Aim 2 - To evaluate the safety of dronabinol in the treatment of agitation in moderate to severe dementia. Hypothesis: Dronabinol is safe for the treatment of agitation in moderate to severe dementia. Approach: Outcomes of safety monitoring are to be measured by physical examination, vital signs with weight, adverse event reports, electrocardiogram, safety labs including complete metabolic panel (CMP), complete blood count (CBC), urinalysis (UA), and treatment compliance. Impact: The potential adverse effects of the 5 mg dose of dronabinol will be evaluated. Exploratory Aims - The investigators will also evaluate the effect of dronabinol on neuropsychiatric symptoms, caregiver distress, cognition, weight, nutritional status, pain, and inflammation.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
All participants will take both dronabinol and placebo at different points in the study in this crossover design trial.
MarinolEligibility
primary outcomes
Time frame: Baseline (0 weeks) to 18 weeks
A 29-item scale to assess 4 dimensions of agitation across a range of frequencies during the previous two weeks. Scores range from 29-203, where higher scores indicate greater agitation severity.
Time frame: Baseline (0 weeks) to 18 weeks
We will compare the frequency of reported adverse events using Common Terminology Criteria for Adverse Events version 4.0
secondary outcomes
Time frame: Baseline (0 weeks) to 18 weeks
This scale provides a comprehensive evaluation of neuropsychiatric symptoms in the previous month across 12 domains of behavior. Total scores range from 0-144, where higher scores reflect a greater level of neuropsychiatric symptom burden.
Time frame: Baseline (0 weeks) to 18 weeks
Caregiver distress is rated for each positive neuropsychiatric symptom domain on a scale of 0 (not distressing at all) to 5 (extremely distressing). Thus total scores range from 0-60 on for the 12 domains.
Time frame: Baseline (0 weeks) to 18 weeks
This modified version of the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change assesses ites specific to agitation in Alzheimer's disease to produce a global rating of change in agitation and a measure of clinical significance. Scores range from 1 to 7 where 1 = marked improvement, 4 = no change, and 7 = marked worsening)
Time frame: Baseline (0 weeks) to 18 weeks
The standardized version of the original MMSE is a 30 point scale to measure global cognition, where lower scores indicate greater cognitive impairment.
Time frame: Baseline (0 weeks) to 18 weeks
This scale includes 11 items, 8 of which are performance based and 3 are ratings of language impairment. Scores range from 0-70, where higher scores indicate greater impairment. This scale will be administered to subjects scoring greater than or equal to 12 on the sMMSE.
Time frame: Baseline (0 weeks) to 18 weeks
The severe impairment battery is a measure of cognition developed for the evaluation of patients whose dementia severity is such that they cannot complete conventional neuropsychological testing. It will be administered to anyone with an sMMSE score less than 12. Scores range from 0 to 133, where lower scores indicate greater impairment.
Time frame: Baseline (0 weeks) to 18 weeks
Assessed by changes in prealbumin (mg/dl)
Time frame: Baseline (0 weeks) to 18 weeks
Assessed by changes in weight (kg)
Time frame: Baseline (0 weeks) to 18 weeks
The PAIN-AD scale is a 5-item rater observed scale to measure pain in patients with dementia. Scores range from 0-10, where higher scores suggest a higher level of pain.
Time frame: Baseline (0 weeks) to 18 weeks
Blood pressure (mm Hg) will be monitored every 2 weeks
Time frame: Baseline (0 weeks) to 18 weeks
Heart rate will be monitored in beats per minute (bpm) every 2 weeks to monitor safety.
Time frame: Baseline (0 weeks) to 18 weeks
EKGs will be monitored at each study visit to assess changes in QTc interval and monitor safety
Publications
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