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

NCT ID: NCT02142777

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-04-30

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

S -Equol

Intervention Type: DRUG

We will determine if the intervention (S-equol) alters platelet mitochondria COX activity.

Placebo

Intervention Type: DRUG

The placebo has no active ingredients but is made to look like the study drug.

Interventions

S -Equol

We will determine if the intervention (S-equol) alters platelet mitochondria COX activity.

Intervention Type: DRUG

Placebo

The placebo has no active ingredients but is made to look like the study drug.

Intervention Type: DRUG

Other Intervention Names

AUS-131

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ausio Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: collaborator

Russell Swerdlow, MD

OTHER

Sponsor Role: lead

Responsible Party

Russell Swerdlow, MD

Gene and Marge Sweeney Professor of Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Russell H Swerdlow, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

STUDY00001228

Identifier Type: -

Identifier Source: org_study_id