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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 50 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
S-equol 		Participants will receive S-equol 50mg twice daily for one month
  • Drug: S-equol
    S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules
    Other names:
    • AUS-131
Placebo Comparator
Placebo 		Participants will receive matched placebo pill to take twice daily for one month
  • Other: Placebo
    Placebo capsules matched in size and color to S-equol capsules

More Details

Status
Completed
Sponsor
Russell Swerdlow

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.