Dementia with Lewy Bodies (DLB) Research Study…Complete

Dementia with Lewy Bodies (DLB) affects over 1 million people in the United States. It is caused by the buildup of abnormal protein clusters, known as “Lewy Bodies,” within the brain and is characterized by fluctuations in cognitive ability, particularly alertness and attention. Many dementia with Lewy Bodies patients also have visual hallucinations and REM sleep behavior disorder. Currently, there are no approved treatments for patients with dementia with Lewy Bodies in the United States or Europe

HEADWAY-DLB is a double-blind Phase 2b clinical research study investigating the safety and effectiveness of a medication, RVT-101, for dementia with Lewy Bodies patients. Approximately 240 people are expected to participate in the study and will be assigned to 1 of the 3 following groups and will therefore have a 67% chance of receiving the investigational medication, RVT-101:

  • Investigational Drug Group 1: RVT-101 (70mg dose)
  • Investigational Drug Group 2: RVT-101 (35mg dose)
  • Comparison Group 3: Placebo

Participant Criteria

In order to be eligible for the study, participants must meet the following criteria:

  • Male / female with clinical diagnosis of dementia with Lewy Bodies for a minimum of 2 months
  • Age 50-85
  • Has a caregiver that can attend appointments

More About RVT-101

RVT-101 is an investigational medication that is not yet approved by a regulatory authority such as the FDA. It is a tablet that is taken once per day and works by raising levels of acetylcholine, which is a chemical in the brain that helps cognitive abilities. RVT-101 has already been tested in 13 completed clinical studies and has been given to over 1,000 patients.

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