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A Phase 2, Double-blind, Randomized, Placebo-controlled Study of Nelotanserin Versus Placebo in Subjects With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) Who Have REM Sleep Behavior Disorder (RBD)
Rochester, Minn.
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).
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A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Subjects with Alzheimer's Disease
Rochester, Minn.
The purpose of this study is to examine the safety and effectiveness of suvorexant (MK-4305) to improve sleep in individuals who have Alzheimer's disease.
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An Open Label Expanded Access Program Intended to Provide Treatment With HBS-101 (Pitolisant) to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to provide access to treatment with pitolisant while a U.S. New Drug Application (NDA) is being prepared and submitted for review for marketing approval. This program will be open to adult patients in the U.S. with Excessive Daytime Sleepiness (EDS) associated with narcolepsy, with or without cataplexy. Pitolisant will be made available through treating physicians participating in the program.
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Cognitive Determinants of Driving Safety in Mild Cognitive Impairment and Early Alzheimer's Disease: A Pilot Study
Rochester, Minn.
Automobile driving is a crucial aspect of everyday life, but driving safety problems including car crashes or speeding violations are a serious public health problem. Alzheimer’s Disease (AD) affects the ability to safely drive and raises crash risk. Mild cognitive impairment (MCI) raises the risk of dementia, and people with MCI have been shown to have problems with memory, decision making, and the ability to concentrate that could lead to unsafe driving, even before obvious dementia begins. Whether MCI patients who continue to drive are safe drivers or not is unknown.
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Development of an EEG Diagnostic for Alzheimer’s Disease: A Feasibility Study (DEEGDAD)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
This study aims to obtain EEG data on individuals at all stages of AD from preclinical through severe dementia.
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Electrophysiologic and Biosensor Signal Analysis of Patients and Controls (PSA)
Rochester, Minn.
The purpose of this study is to measure electrophysiologic biosensor signals recorded from patients. We will measure electrophysiologic and biosensor signals in patients with neurological, psychiatric, sleep and medical disorders, and compare them to measurements in age- and sex-matched controls without these disorders, and analyze medical records to determine possible demographic or clinical predictors for observed differences in signal characteristics between patients and controls. The goal is to define biosensor signal characteristics and alterations in human subjects and their associations with clinical characteristics and to explore changes in biosensor characteristics over time in selected individuals.
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Prevalence of Probable and Diagnosed REM Sleep Behavior Disorder Using the Rochester Epidemiology Project
Rochester, Minn.
The purpose of this study is to determine the frequency of sleep behavior disorder by age group and sex in Olmsted County MN.
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