S-Equol in Alzheimer's Disease (SEAD) Trial

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: S -Equol; Drug: Placebo

• Registration Number: NCT02142777
• Lead Sponsor: Russell Swerdlow, MD

Brief Summary

The purpose of this study is to determine if S-equol could benefit persons with Alzheimer's Disease (AD).

Detailed Description

Alzheimer's disease (AD) is a progressive brain disorder which causes memory and thinking problems. The exact cause of AD is unknown. Researchers believe mitochondria (the part of your cells that produces energy) might be linked to symptoms of AD. Some studies have shown that patients with Alzheimer's disease have reduced mitochondrial activity or have fewer mitochondria present in neurons. In this study, it is believed that by targeting mitochondria, we might learn more about its influence on AD symptoms.

Mitochondria have a receptor site for estrogen (a hormone) called estrogen receptor β (ERβ). When estrogen attaches to this site, it promotes mitochondrial function. Studies have also suggested ERβ stimulation can cause cells to create new mitochondria. More mitochondria, or increased activity of existing mitochondria, in the cell might have an impact on patients with Alzheimer's disease. One way to measure this increase in function is to look for the presence of an enzyme called COX in your blood. If a drug increases mitochondrial function, there will be an increase in COX concentration in the bloodstream.

By doing this study we hope to learn if S-equol, a compound that acts like estrogen in the body, causes such an increase in mitochondrial activity. We also hope to determine the tolerability of a therapeutic dose of S-equol. It is our goal to advance the understanding of AD, particularly in women.

Study Timeline

• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-20
• Study Start: 2014-07
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-12
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Very mild (CDR 0.5) or mild (CDR 1) AD at time of last KU ADC assessment
• Have a study partner
• Speak English as primary language

Exclusion Criteria

• No viable study partner
• Report a potentially confounding, serious medical risk such as type 1 diabetes, cancer, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)
• Use any type of estrogen replacement therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational	S -Equol	All study subjects will take a 10mg pill by mouth twice daily over a 6 week period. Subjects will receive either placebo or S -Equol. They will not know which they are receiving.
Investigational	Placebo	All study subjects will take a 10mg pill by mouth twice daily over a 6 week period. Subjects will receive either placebo or S -Equol. They will not know which they are receiving.

Primary Outcome Measures

Name	Time	Method
platelet mitochondria cytochrome oxidase (COX) activity	Change from Baseline to 6 Weeks	Activity will be identified by the percentage of subjects who show an increase in COX activity while on the active treatment as compared to the COX activity while on placebo.

Secondary Outcome Measures

Name	Time	Method
safety of S-equol	6 Weeks	Determine if 10mg twice daily is a safe and well tolerated dose for persons with AD. Safety will be ascertained through the use of a questionnaire that queries a list of standard drug side effects.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States