S-Equol in Alzheimer's Disease 2 Trial
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Alzheimer Disease
In brief
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.
Key facts
- Study ID
- NCT03101085
- Run by
- Russell Swerdlow
- People needed
- 40
- Starts
- 2017-05-05
- Expected to finish
- 2021-03-01
- Last updated by the study team
- 2024-07-25
Who can join
Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinical and Translational Science Unit — Fairway, Kansas, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
Full record on ClinicalTrials.gov
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