Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Disinhibition Syndrome
In brief
Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.
Key facts
- Study ID
- NCT02534038
- Run by
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- People needed
- 1
- Starts
- 2015-12-01
- Expected to finish
- 2017-10-03
- Last updated by the study team
- 2026-05-13
Who can join
Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented diagnosis of a Neurodegenerative Disorder including frontotemporal dementia, Alzheimer's disease (AD), progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), dementia with Lewy bodies (DBL), vascular cognitive disorders, or Huntington's disease, at least 3 months prior to Baseline
- The participant has behavior from 2 of the 3 categories of disinhibited behavior from the definition of the behavioral variant of frontotemporal dementia
- The behavioral changes are not due to a pre-existing major psychiatric disorder (e.g., schizophrenia, bipolar disease, etc.) and are not due to the direct effect of systemic illness, drug action, or substance use
- Disinhibition scale score of ≥4 on the 3 core disinhibition items of the Frontal Behavioral Inventory (FBI) at Screening and Baseline
You may not qualify if…
- Participants with symptoms of disinhibition that is not secondary to Neurodegenerative Disorders
- Participants with myasthenia gravis
- Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy [except skin basal-cell carcinoma or untreated prostate cancer], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
Where it is running
- Cleveland Clinic Lou Ruvo Center for Brain Health — Las Vegas, Nevada, United States
Full record on ClinicalTrials.gov
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