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NCT Number: NCT02669433

Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study

This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.

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Key information

Conditions

Dementia With Lewy Bodies Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CA200, Toronto, Ontario, Canada

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About this study

The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a 24-week double-blind treatment period in patients with dementia with Lewy bodies.

The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo).

Subjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subject with probable DLB
  • Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline
  • Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator
  • Patient has a reliable caregiver who is willing to report on the subject's status throughout the study
  • Patients currently receiving therapy for DLB are eligible for enrollment

Exclusion criteria

  • Atypical clinical features or clinical course that would lead the investigator to conclude primary symptoms are more likely explained by an alternate dementia diagnosis.
  • Any clinically relevant concomitant disease that, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study.

Treatment and study plan

RVT-101 35 mg

Drug

once daily, oral, 35-mg tablets

RVT-101 70 mg

Drug

once daily, oral, 35-mg tablets

Placebo

Drug

once daily, oral, matching tablets

Primary outcomes

  1. Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24

    Time frame: Change from Baseline at 24 weeks

    The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.

Secondary outcomes

  1. Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24

    Time frame: Change from Baseline at 24 weeks

    The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.

  2. Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24

    Time frame: Change from Baseline at 24 weeks

    To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.

Sponsors and collaborators

Lead sponsor

Axovant Sciences Ltd.

Industry

Registry information

Official study title

A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 1, 2016
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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