A Phase 2 interventional study of Dronabinol in Dementia Moderate, Dementia Severe and Agitation,Psychomotor, sponsored by Ralph H. Johnson VA Medical Center. Withdrawn at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Ralph H. Johnson VA Medical Center · Phase 2, Interventional, and Treatment
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:
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:
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.
231 studies on the registry are indexed under Psychomotor Agitation; 28 are open to participants now.
Browse Psychomotor Agitation studies →Ralph H. Johnson VA Medical Center is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will take Dronabinol 2.5 mg capsules twice daily for 1 week, followed by dronabinol 5 mg twice daily for 6 weeks, followed by dronabinol 2.5 mg twice daily for 1 week. They will then undergo a 3-week washout period, followed by placebo capsules twice daily for 8 weeks.
Drug: Dronabinol
Participants will take matching placebo capsules twice daily for 8 weeks, followed by a three week washout period. They will then begin taking dronabinol 2.5 mg capsules twice daily for 1 week, followed by dronabinol 5 mg twice daily for 6 weeks, followed by dronabinol 2.5 mg twice daily for 1 week.
Drug: Dronabinol
All participants will take both dronabinol and placebo at different points in the study in this crossover design trial.
Also known as: Marinol
Change in agitation, Cohen Mansfield Agitation Inventory (CMAI)
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
Safety and tolerability, Treatment Emergent Adverse Events
We will compare the frequency of reported adverse events using Common Terminology Criteria for Adverse Events version 4.0
Time frame: Baseline (0 weeks) to 18 weeks
Change in agitation, Neuropsychiatric Inventory (NPI)
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
Change in caregiver distress, Neuropsychiatric Inventory - Caregiver distress score
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
Clinically perceptible effect of dronabinol on agitation, modified Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (mADAS-CGIC)
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
Change in cognition, standardized Mini Mental Status Examination (sMMSE)
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
Change in cognition, Alzheimer's Disease Assessment Scale - Cognitive Section (ADAS-Cog)
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
Change in cognition, Severe Impairment Battery
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
Change in nutritional status, prealbumin
Assessed by changes in prealbumin (mg/dl)
Time frame: Baseline (0 weeks) to 18 weeks
Change in nutritional status, weight
Assessed by changes in weight (kg)
Time frame: Baseline (0 weeks) to 18 weeks
Change in pain, Pain Assessment in Advanced AD (PAIN-AD) scale
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
Change in blood pressure
Blood pressure (mm Hg) will be monitored every 2 weeks
Time frame: Baseline (0 weeks) to 18 weeks
Change in heart rate
Heart rate will be monitored in beats per minute (bpm) every 2 weeks to monitor safety.
Time frame: Baseline (0 weeks) to 18 weeks
Change in QTc interval on Electrocardiogram (EKG)
EKGs will be monitored at each study visit to assess changes in QTc interval and monitor safety
Time frame: Baseline (0 weeks) to 18 weeks
Plan to share: No
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This study is withdrawn, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dronabinol
Ralph H. Johnson VA Medical Center