Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Axovant Sciences Ltd.
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).
Age
50–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
