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

Axovant Sciences Ltd.484 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

484

Conditions

Dementia With Lewy Bodies

Interventions

RVT-101 35 mgDRUG

once daily, oral, 35-mg tablets

RVT-101 70 mgDRUG

once daily, oral, 35-mg tablets

PlaceboDRUG

once daily, oral, matching tablets

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (65)

Outcomes

Primary Outcomes

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

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.

Time frame: Change from Baseline at 24 weeks

Secondary Outcomes

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

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.

Time frame: Change from Baseline at 24 weeks

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

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.

Time frame: Change from Baseline at 24 weeks

Data from ClinicalTrials.gov

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Sun City, Arizona, United States

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Tucson, Arizona, United States

US119

Irvine, California, United States

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Oxnard, California, United States

US133

Rancho Mirage, California, United States

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Sacramento, California, United States

US141

Englewood, Colorado, United States

US123

Washington D.C., District of Columbia, United States

...and 55 more locations