S-Equol in Alzheimer's Disease 2 Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 50 - 90 |
| Updated: | 3/15/2019 |
| Start Date: | May 5, 2017 |
| End Date: | October 30, 2019 |
| Contact: | Annette Becker |
| Email: | abecker@kumc.edu |
| Phone: | (913) 945-7674 |
S-Equol in Alzheimer's Disease 2 (SEAD2) 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.
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.
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
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