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

Axovant Sciences

Status and phase: Completed; Phase 2

Conditions: Dementia With Lewy Bodies

Treatments: Drug: Placebo; Drug: RVT-101 35 mg; Drug: RVT-101 70 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02669433

RVT-101-2001

Details and patient eligibility

About

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

Full description

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).

Enrollment: 484 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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484 participants in 3 patient groups, including a placebo group

RVT-101 35 mg

Experimental group

Description:

RVT-101 35 mg once daily

Treatment:

Drug: RVT-101 35 mg

RVT-101 70 mg

Experimental group

Description:

RVT-101 70 mg once daily

Treatment:

Drug: RVT-101 70 mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo