S-Equol in Alzheimer's Disease 2 Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-05

Study Completion Date

2021-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type OTHER

S-equol and Placebo

Intervention Type DRUG

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.

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.

Group Type OTHER

Placebo and S-equol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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S-equol is also called AUS-131 S-equol is also called AUS-131

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No