Skip to main content
Delfa

← Trials/Trial dossier/NCT02871427

TerminatedPhase 2

Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder

An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder

Asset

Nelotanserin

Listed sites

19

Recruiting sites

-

Enrollment

80

estimated

Study population

Lewy body dementia

Key I/E criterion

•Age ≥50

Primary endpoints

•Long-term safety and tolerability•Long-term effectiveness

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 IDNCT02871427
Org study IDRVT-102-2003

Timeline

Milestones

Study first posted2016-08-18estimated
Study start2016-10-20actual
Primary completion2019-01-17actual
Study completion2019-01-17actual
Last update posted2019-03-27actual

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

•Subjects with LBD who completed a previous nelotanserin VH or RBD study

Exclusion criteria

•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.

Coverage by outcome category

Behavior / neuropsychiatric
1
Safety / tolerability / PK
1

Behavior / neuropsychiatric

1 endpoint
Primary/protocol endpoint

Long-term effectiveness will be evaluated based on change in the frequency and severity of visual hallucinations (as recorded by patient's caregiver) and/or REM sleep behaviors (based on a clinical evaluator) over time during treatment.

Time frame:24 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Long-term safety and tolerability will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and clinical laboratory assessments over time during treatment.

Time frame:24 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.