S-Equol in Alzheimer's Disease 2 Trial

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.

Eligibility 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

Principal Investigator

Russell Swerdlow, MD

Study Contact

Annette Becker, abecker@kumc.edu, (913) 945-7674

Estimated Completion Date

Monday, September 30, 2019

ClinicalTrials.gov #

NCT03101085
06/06/2017