S-Equol in Alzheimer's Disease 2 Trial

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

By doing this study researchers hope to learn if S-equol, a compound that acts like estrogen in the body, causes an increase in mitochondrial activity. Researchers also hope to determine the safety and tolerability of a therapeutic dose of S-equol and whether or not it influences cognition.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Russell Swerdlow; Russell Swerdlow, MD
• Collaborator: Ausio Pharmaceuticals, LLC
• Treatments: Equol

Criteria

Inclusion Criteria:

• Have a diagnosis of Alzheimer's Disease (AD)

• Have a study partner who has a close relationship with the participant and will attend study visits with the participant

• Do not possess an Alkylphenol ethoxylates 4 (APOE4) variant of the APOE gene

• Speak English as their primary language

• Have not had any medication changes within the past 30 days

Exclusion Criteria:

• Reside in a nursing home or dementia special care unit

• Have a potentially confounding, serious medical risk such as insulin-requiring diabetes, any history of cancer that required a chemotherapy or radiation therapy intervention within the past 5 years, or a recent cardiac event

• Have any clinically significant abnormal safety laboratory values at the SEAD2 screening visit

• Have any clinically significant abnormal findings on vital signs measurements, or on physical or neurological examination at the SEAD2 screening visit

• Use any type of systemic estrogen or testosterone replacement therapy

• Has participated in another clinical trial or received any investigational drug or investigational therapy within 30 days before the screening visit