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