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

Sponsor
Russell Swerdlow, MD (Other)
Overall Status
Completed
CT.gov ID
NCT02142777
Collaborator
Ausio Pharmaceuticals, LLC (Industry)
15
Enrollment
1
Location
1
Arm
21
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: S -Equol
  • Drug: Placebo
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
S-Equol in Alzheimer's Disease (SEAD) Trial
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 90 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kansas Medical Center Kansas City Kansas United States 66160

    Sponsors and Collaborators

    • Russell Swerdlow, MD
    • Ausio Pharmaceuticals, LLC

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Russell Swerdlow, MD, Gene and Marge Sweeney Professor of Neurology, University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT02142777
    Other Study ID Numbers:
    • STUDY00001228
    First Posted:
    May 20, 2014
    Last Update Posted:
    Aug 16, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Russell Swerdlow, MD, Gene and Marge Sweeney Professor of Neurology, University of Kansas Medical Center
    S-equol
    COX activity
    Additional relevant MeSH terms:
    Alzheimer Disease
    Equol

    Study Results

    No Results Posted as of Aug 16, 2016