Clinical trial NCT02640729: Study Evaluating Nelotanserin for Treatment of Visual Hallucinations in Subjects With Lewy Body Dementia
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lewy Body Dementia
Visual Hallucinations
Keywords: Lewy body dementia
Dementia with Lewy bodies
Parkinson's disease dementia
Lewy bodies
Visual hallucinations
Lead sponsor: Sio Gene Therapies
Sponsor class: INDUSTRY
First posted: 2015-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 28 days
measure: Extrapyramidal signs are assessed with the motor subsection of the Unified Parkinson's Disease Rating Scale (UPDRS, Parts II and III).
timeFrame: 28 days
Secondary outcomes:
measure: 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
timeFrame: 28 days
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: US123
state: California
city: Boca Raton
country: United States
facility: US114
state: Florida
city: Orlando
country: United States
facility: US113
state: Florida
city: Lenexa
country: United States
facility: US132
state: Kansas
city: Rochester
country: United States
facility: US103
state: Minnesota
city: Lincoln
country: United States
facility: US129
state: Nebraska
city: Chapel Hill
country: United States
facility: US101
state: North Carolina
city: Cleveland
country: United States
facility: US104
state: Ohio
city: Columbus
country: United States
facility: US105
state: Ohio
city: San Antonio
country: United States
facility: US131
state: Texas
Study officials:
affiliation: Axovant Sciences, Inc., Clinical Research
name: Ilise Lombardo, MD
role: STUDY_DIRECTOR
References: