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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Axovant Sciences Ltd.
Sponsor:
Information provided by (Responsible Party):
Axovant Sciences Ltd.
ClinicalTrials.gov Identifier:
NCT02640729
First received: December 19, 2015
Last updated: January 6, 2017
Last verified: January 2017
  Purpose
This study seeks to evaluate safety and efficacy of Nelotanserin for the treatment of visual hallucinations in subjects with Lewy body dementia.

Condition Intervention Phase
Lewy Body Dementia
Visual Hallucinations
Drug: Nelotanserin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Axovant Sciences Ltd.:

Primary Outcome Measures:
  • 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 ]
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: December 2015
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nelotanserin
Nelotanserin 40mg then nelotanserin 80 mg
Drug: Nelotanserin
once daily, oral, 20-mg tablets
Placebo Comparator: Placebo
Placebo
Drug: Placebo
once daily, oral, matching tablets

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects aged 50-85, inclusive, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02640729

Contacts
Contact: Axovant Clinical Trials; https://www.lbda.org/nelotanserin-VH 919-425-0709
Contact: Lydia Hatfield

Locations
United States, California
US123 Recruiting
Fountain Valley, California, United States, 92708
United States, Florida
US114 Recruiting
Boca Raton, Florida, United States, 33486
US113 Recruiting
Orlando, Florida, United States, 32806
United States, Kansas
US132 Recruiting
Lenexa, Kansas, United States, 66214
United States, Minnesota
US103 Recruiting
Rochester, Minnesota, United States, 55905
United States, Nebraska
US129 Recruiting
Lincoln, Nebraska, United States, 68526
United States, North Carolina
US101 Recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
US104 Recruiting
Cleveland, Ohio, United States, 44195
US105 Recruiting
Columbus, Ohio, United States, 43210
United States, Texas
US131 Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
Study Director: Warren Wen Axovant Sciences, Inc., Clinical Research
  More Information

Additional Information:
Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02640729     History of Changes
Other Study ID Numbers: RVT-102-2001 
Study First Received: December 19, 2015
Last Updated: January 6, 2017

Keywords provided by Axovant Sciences Ltd.:
Lewy body dementia
Dementia with Lewy bodies
Parkinson's disease dementia
Lewy bodies
Visual hallucinations

Additional relevant MeSH terms:
Dementia
Hallucinations
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on February 24, 2017