NCT02640729

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

December 19, 2015

Last Update Submit

January 16, 2018

Conditions

Lewy Body DementiaVisual Hallucinations

Keywords

Lewy body dementiaDementia with Lewy bodiesParkinson's disease dementiaLewy bodiesVisual hallucinations

Outcome Measures

Primary Outcomes (2)

  • 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).

    28 days

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

    28 days

Secondary Outcomes (1)

  • 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

    28 days

Study Arms (2)

Nelotanserin

EXPERIMENTAL

Nelotanserin 40mg then nelotanserin 80 mg

Drug: Nelotanserin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

NelotanserinDRUG

once daily, oral, 20-mg tablets

Nelotanserin
PlaceboDRUG

once daily, oral, matching tablets

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

US123

Fountain Valley, California, 92708, United States

Location

US114

Boca Raton, Florida, 33486, United States

Location

US113

Orlando, Florida, 32806, United States

Location

US132

Lenexa, Kansas, 66214, United States

Location

US103

Rochester, Minnesota, 55905, United States

Location

US129

Lincoln, Nebraska, 68526, United States

Location

US101

Chapel Hill, North Carolina, 27514, United States

Location

US104

Cleveland, Ohio, 44195, United States

Location

US105

Columbus, Ohio, 43210, United States

Location

US131

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Lewy Body DiseaseHallucinations

Interventions

nelotanserin

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ilise Lombardo, MD

    Axovant Sciences, Inc., Clinical Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2015

First Posted

December 29, 2015

Study Start

December 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

US(10)