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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study seeks to evaluate safety and efficacy of Nelotanserin for the treatment of visual hallucinations in subjects with Lewy body dementia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02871427

Lewy Body Dementia Dementia With Lewy Bodies Parkinson's Disease Dementia +2 more

TERMINATED PHASE2

A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)

NCT03305809

Lewy Body Dementia

COMPLETED PHASE2

24 Months Safety and Efficacy Study of AADvac1 in Patients With Mild Alzheimer's Disease

NCT02579252

Alzheimer's Disease

COMPLETED PHASE2

Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease

NCT03352557

Alzheimer's Disease

TERMINATED PHASE2

Safety and Efficacy of Galantamine in Patients With Dementia With Lewy Bodies

NCT00230997

Lewy Body Disease

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a double-blind, randomized, placebo-controlled, cross-over study in subjects with Lewy body dementia who experience frequent visual hallucinations.

Subjects who meet the randomization criteria enter the double-blind treatment period.

Each subject will be randomized 1:1 to one of the 2 treatment sequences: Nelotanserin in the first treatment period followed by placebo in the second treatment period, or placebo in the first treatment period followed by Nelotanserin in the second treatment period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lewy Body Dementia Visual Hallucinations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nelotanserin

Nelotanserin 40mg then nelotanserin 80 mg

Group Type EXPERIMENTAL

Nelotanserin

Intervention Type DRUG

once daily, oral, 20-mg tablets

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

once daily, oral, matching tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nelotanserin

once daily, oral, 20-mg tablets

Intervention Type DRUG

Placebo

once daily, oral, matching tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No