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

August 12, 2016 updated by: Russell Swerdlow, MD
The purpose of this study is to determine if S-equol could benefit persons with Alzheimer's Disease (AD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational
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.
Drug: S -Equol
We will determine if the intervention (S-equol) alters platelet mitochondria COX activity.
Other Names:
  • AUS-131
Drug: Placebo
The placebo has no active ingredients but is made to look like the study drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
platelet mitochondria cytochrome oxidase (COX) activity
Time Frame: 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.
Change from Baseline to 6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of S-equol
Time Frame: 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.
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Russell Swerdlow, MD

Collaborators

Ausio Pharmaceuticals, LLC

Investigators

  • Principal Investigator: Russell H Swerdlow, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 12, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001228

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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