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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dementia With Lewy Bodies

In brief

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

Key facts

Study ID

NCT02669433

Run by

Axovant Sciences Ltd.

People needed

484

Starts

2016-01-01

Expected to finish

2017-12-01

Last updated by the study team

2019-04-26

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• US108 — Phoenix, Arizona, United States
• US139 — Sun City, Arizona, United States
• US125 — Tucson, Arizona, United States
• US119 — Irvine, California, United States
• US134 — Oxnard, California, United States
• US133 — Rancho Mirage, California, United States
• US140 — Sacramento, California, United States
• US141 — Englewood, Colorado, United States
• US123 — Washington D.C., District of Columbia, United States
• US104 — Boca Raton, Florida, United States
• US116 — Boca Raton, Florida, United States
• US111 — Jacksonville, Florida, United States
• US122 — Orlando, Florida, United States
• US137 — Palm Beach Gardens, Florida, United States
• US126 — Tampa, Florida, United States
• US136 — Atlanta, Georgia, United States
• US112 — Chicago, Illinois, United States
• US118 — Indianapolis, Indiana, United States
• US105 — Lexington, Kentucky, United States
• US135 — Newton, Massachusetts, United States
• US130 — Quincy, Massachusetts, United States
• US102 — Rochester, Minnesota, United States
• US109 — New York, New York, United States
• US100 — Chapel Hill, North Carolina, United States
• US138 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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