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 Sex
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
Other
S-equol First, Then Placebo 		In this arm, participants receive S-equol 50mg twice daily for one month, followed by placebo twice daily for one month. There was no washout period.
  • Drug: S-equol and Placebo
    S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules. The placebo is a matched pill that cannot be distinguished from the active S-equol.
    Other names:
    • S-equol is also called AUS-131
Other
Placebo First, Then S-equol 		In this arm, participants receive placebo twice daily for one month, followed by S-equol 50mg twice daily for one month. There was no washout period.
  • Drug: Placebo and S-equol
    S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules. The placebo is a matched pill that cannot be distinguished from the active S-equol.
    Other names:
    • S-equol is also called AUS-131

More Details

Status
Completed
Sponsor
Russell Swerdlow

Study Contact

Detailed Description

Enrolled participants with a diagnosis of Alzheimer's Disease (AD) will be randomized to receive either S-equol or placebo first, and then cross over to receive the opposite intervention. The study, therefore, consists of two treatment periods with randomly assigned treatment order. Specifically, subjects are randomized to either: (1) S-equol for one month, then placebo for one month; or (2) placebo for one month, then S-equol for one month.