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

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.