Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Dementia With Lewy Bodies, REM Sleep Behavior Disorder, Parkinson's Disease Dementia

In brief

This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD).

Key facts

Study ID

NCT02708186

Run by

Axovant Sciences Ltd.

People needed

34

Starts

2016-03-01

Expected to finish

2018-05-01

Last updated by the study team

2020-05-20

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subjects at least 50 years of age, with a diagnosis of DLB or PDD and RBD based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) diagnostic criteria
• Presence of frequent REM sleep behavior episodes
• Mini Mental State Examination score ≥ 18

You may not qualify if…

• Subjects have a current diagnosis of significant psychotic disorders including, but not limited to, schizophrenia or bipolar disorder
• Subjects' RBD symptoms are secondary to or better accounted for by another medical condition, psychiatric disorder, or substance abuse
• Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder

Where it is running

• US120 — Birmingham, Alabama, United States
• US164 — Phoenix, Arizona, United States
• US145 — Sun City, Arizona, United States
• US143 — Little Rock, Arkansas, United States
• US122 — Englewood, Colorado, United States
• US180 — Maitland, Florida, United States
• US154 — Ocala, Florida, United States
• US113 — Orlando, Florida, United States
• US152 — Ormond Beach, Florida, United States
• US153 — Tampa, Florida, United States
• US163 — Atlanta, Georgia, United States
• US107 — Indianapolis, Indiana, United States
• US132 — Lenexa, Kansas, United States
• US129 — Lincoln, Nebraska, United States
• US101 — Chapel Hill, North Carolina, United States
• US159 — New Bern, North Carolina, United States
• US147 — Fargo, North Dakota, United States
• US111 — Cincinnati, Ohio, United States
• US104 — Cleveland, Ohio, United States
• US105 — Columbus, Ohio, United States
• US173 — Lincoln, Rhode Island, United States
• US128 — Memphis, Tennessee, United States
• US131 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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