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CompletedPhase 2

Study Evaluating Nelotanserin for Treatment of Visual Hallucinations in Subjects With Lewy Body Dementia

A Phase 2, Double-blind, Randomized, Placebo-controlled Cross-over Study of Nelotanserin Versus Placebo in Lewy Body Dementia (LBD) Subjects Experiencing Visual Hallucinations (VH)

Asset

Nelotanserin

Listed sites

10

Recruiting sites

-

Enrollment

30

actual

Study population

Lewy body dementia

Key I/E criteria

•Parkinson's disease dementia•MMSE ≥18

Primary endpoints

•Safety•Extrapyramidal signs

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 IDNCT02640729
Org study IDRVT-102-2001

Timeline

Milestones

Study start2015-12actual (month precision)
Study first posted2015-12-29estimated
Primary completion2017-11actual (month precision)
Study completion2017-11actual (month precision)
Last update posted2018-01-18actual

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 LBD based on DSM-5 diagnostic criteria or diagnosis of Parkinson's disease dementia (PDD) based on DSM-5 diagnostic criteria;
•Presence of frequent visual hallucinations
•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' psychotic 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 (3)

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

Caregiver / quality of life
1
Safety / tolerability / PK
1
Other (unclassified)
1

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Change in the frequency and severity of visual hallucinations from baseline to the end of each treatment period (28 days) with Nelotanserin or placebo, as recorded and documented by the patient's caregiver

Time frame:28 days

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Safety will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and routine clinical laboratory assessments from baseline to the end of each treatment period (28 days).

Time frame:28 days

event count, event

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Extrapyramidal signs are assessed with the motor subsection of the Unified Parkinson's Disease Rating Scale (UPDRS, Parts II and III).

Time frame:28 days

descriptive

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.