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CompletedPhase 2Results posted

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

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)

Asset

Nelotanserin

Listed sites

23

Recruiting sites

-

Enrollment

34

actual

Study population

Lewy body dementia

Key I/E criteria

•Parkinson's disease dementia•MMSE ≥18

Primary endpoint

•The Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02708186
Org study IDRVT-102-2002

Timeline

Milestones

Study start2016-03actual (month precision)
Study first posted2016-03-15estimated
Primary completion2018-05actual (month precision)
Study completion2018-05actual (month precision)
Last update posted2020-05-20actual
Results first posted2020-05-20actual

Assets

Drug assets

Nelotanserin

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator.

Time frame:28 days

change from baseline, improvement

Primary/registry result

Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator.

Time frame:28 days

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Number of RBD per 10 minStandard error
Nelotanserinn=16 Participants-1.471.006
Placebon=18 Participants-0.261.027

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.