S-Equol in Alzheimer's Disease 2 Trial

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

  • Alzheimer Disease

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