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



Status:Completed
Conditions:Alzheimer Disease, Parkinsons Disease, Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:50 - Any
Updated:10/25/2018
Start Date:March 2016
End Date:May 2018

Use our guide to learn which trials are right for you!

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)

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).

This is a double-blind, randomized, placebo-controlled, parallel-arm study in subjects with
DLB or PDD who have RBD.

Subjects who meet the randomization criteria will be randomized 1:1 to receive Nelotanserin
or placebo for 28 days during the double-blind period.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
23
sites
Memphis, Tennessee 38613
1132
mi
from 02139
Memphis, TN
Click here to add this to my saved trials
Atlanta, Georgia 30331
934
mi
from 02139
Atlanta, GA
Click here to add this to my saved trials
Birmingham, Alabama 35294
1049
mi
from 02139
Birmingham, AL
Click here to add this to my saved trials
101 Manning Drive
Chapel Hill, North Carolina 27514
616
mi
from 02139
Chapel Hill, NC
Click here to add this to my saved trials
Cincinnati, Ohio 45229
732
mi
from 02139
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44195
543
mi
from 02139
Cleveland, OH
Click here to add this to my saved trials
Columbus, Ohio 43210
640
mi
from 02139
Columbus, OH
Click here to add this to my saved trials
122 Englewood Parkway
Englewood, Colorado 80113
1764
mi
from 02139
Englewood, CO
Click here to add this to my saved trials
Fargo, North Dakota 58103
1296
mi
from 02139
Fargo, ND
Click here to add this to my saved trials
Indianapolis, Indiana 46202
803
mi
from 02139
Indianapolis, IN
Click here to add this to my saved trials
Lenexa, Kansas 66214
1255
mi
from 02139
Lenexa, KS
Click here to add this to my saved trials
129 Nebraska 2
Lincoln, Nebraska 68526
1323
mi
from 02139
Lincoln, NE
Click here to add this to my saved trials
Lincoln, Rhode Island 02865
?
mi
from 02139
Lincoln, RI
Click here to add this to my saved trials
Little Rock, Arkansas 72205
1255
mi
from 02139
Little Rock, AR
Click here to add this to my saved trials
Maitland, Florida 32751
1108
mi
from 02139
Maitland, FL
Click here to add this to my saved trials
1420 McCarthy Boulevard
New Bern, North Carolina 28562
596
mi
from 02139
New Bern, NC
Click here to add this to my saved trials
154 Old US Highway 301
Ocala, Florida 34471
1097
mi
from 02139
Ocala, FL
Click here to add this to my saved trials
Orlando, Florida 32806
1115
mi
from 02139
Orlando, FL
Click here to add this to my saved trials
Ormond Beach, Florida 32174
1060
mi
from 02139
Ormond Beach, FL
Click here to add this to my saved trials
Phoenix, Arizona 85013
2292
mi
from 02139
Phoenix, AZ
Click here to add this to my saved trials
131 Old Highway 90 West
San Antonio, Texas 78229
1765
mi
from 02139
San Antonio, TX
Click here to add this to my saved trials
Sun City, Arizona 85351
2298
mi
from 02139
Sun City, AZ
Click here to add this to my saved trials
Tampa, Florida 33613
1182
mi
from 02139
Tampa, FL
Click here to add this to my saved trials