Expired Study
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Las Vegas, Nevada 89106


Purpose:

Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.


Study summary:

Eligible participants for this study must have a diagnosis of Neurodegenerative Disorder and must exhibit disinhibition syndrome of sufficient severity to warrant treatment. This is a multicenter, randomized, double-blind, placebo-controlled, cross-over study consisting of two 6-week treatment periods. Approximately 12 participants will be enrolled at approximately 2 centers in the United States. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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)


NCT ID:

NCT02534038


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Las Vegas, Nevada 89106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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