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RVT-101 for Dementia with Lewy Bodies (HEADWAY-DLB)

Completed

Researchers will test the efficacy and safety of the experimental drug RVT-101 in people with dementia with Lewy bodies, including its effect on visual hallucinations.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 85 Years Both No
January 2016
October 2017
240

  • Probable dementia with Lewy bodies
  • Mini-Mental State Examination score of 14-26 inclusive
  • Ability to comply with procedures for cognitive and other testing
  • Reliable caregiver who can report on participant's status throughout study

  • Atypical clinical features or clinical course that suggest diagnosis other than dementia with Lewy bodies
  • Any clinically relevant disease that makes the patient unsuitable for the study

Participants will be randomly assigned to one of three groups. The first group will take the test drug RVT-101 at a dose of 35 mg once daily, and the second group at 70 mg once daily. The third group will take a placebo. All are administered as tablets taken for 24 weeks.

RVT-101 is a small molecule that affects specific neurotransmitters in the brain. The drug works by acting on the 5HT6 receptor in the brain, enhancing the release of acetylcholine, a neurotransmitter believed to be critical for learning and memory.

Subjects completing this study will be eligible to enroll in an extension study of RVT-101.

For more information about this trial, contact Axovant Clinical Trials at 1-646-677-5778.

Name City State Zip Status Primary Contact
US138
Phoenix Arizona 85006

US108
Phoenix Arizona 85013

US139
Sun City Arizona 85351

US125
Tucson Arizona 85704

US119
Irvine California 92868

US134
Oxnard California 93030

US133
Rancho Mirage California 92270

US140
Sacramento California 95816

US141
Englewood Colorado 80113

US123
Washington District of Columbia 20007

US104
Boca Raton Florida 33431

US116
Boca Raton Florida 33486

US111
Jacksonville Florida 32224

US122
Orlando Florida 32806

US137
Palm Beach Gardens Florida 33410

US126
Tampa Florida 33609

US136
Atlanta Georgia 30331

US112
Chicago Illinois 60612

US118
Indianapolis Indiana 46202

US105
Lexington Kentucky 40536

US135
Newton Massachusetts 02459

US130
Quincy Massachusetts 02196

US102
Rochester Minnesota 55905

US109
New York New York 10032

US100
Chapel Hill North Carolina 27514

US110
Cleveland Ohio 44195

US106
Columbus Ohio 43210

US131
Portland Oregon 97210

US120
Willow Grove Pennsylvania 19090

US124
Dallas Texas 75390

US101
Charlottesville Virginia 22908

CA200
Toronto Ontario M4N 3M5

CA201
Sherbrooke Quebec J1J 3H5

Axovant Sciences Ltd.

Name Role Affiliation
Ilise Lombardo, MD Study Director Axovant Sciences Inc.

Name Phone Email
Axovant Clinical Trials 646-495-8197

NCT02669433

A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)