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

Overview

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

Full Title of Study: “S-Equol in Alzheimer’s Disease (SEAD) Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 2016

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.

Interventions

  • Drug: S -Equol
    • We will determine if the intervention (S-equol) alters platelet mitochondria COX activity.
  • Drug: Placebo
    • The placebo has no active ingredients but is made to look like the study drug.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 60 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Russell Swerdlow, MD
  • Collaborator
    • Ausio Pharmaceuticals, LLC
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Russell Swerdlow, MD, Gene and Marge Sweeney Professor of Neurology – University of Kansas Medical Center
  • Overall Official(s)
    • Russell H Swerdlow, MD, Principal Investigator, University of Kansas Medical Center

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