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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axovant Sciences Ltd.

Criteria

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.