S-Equol in Alzheimer's Disease (SEAD) Trial (SEAD)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
S -Equol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring S-equol, COX activity
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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigational
Arm Description
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.
Outcomes
Primary Outcome Measures
platelet mitochondria cytochrome oxidase (COX) activity
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
safety of S-equol
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.
Full Information
NCT ID
NCT02142777
First Posted
May 8, 2014
Last Updated
August 12, 2016
Sponsor
Russell Swerdlow, MD
Collaborators
Ausio Pharmaceuticals, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02142777
Brief Title
S-Equol in Alzheimer's Disease (SEAD) Trial
Acronym
SEAD
Official Title
S-Equol in Alzheimer's Disease (SEAD) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Russell Swerdlow, MD
Collaborators
Ausio Pharmaceuticals, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
S-equol, COX activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
S -Equol
Other Intervention Name(s)
AUS-131
Intervention Description
We will determine if the intervention (S-equol) alters platelet mitochondria COX activity.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo has no active ingredients but is made to look like the study drug.
Primary Outcome Measure Information:
Title
platelet mitochondria cytochrome oxidase (COX) activity
Description
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.
Time Frame
Change from Baseline to 6 Weeks
Secondary Outcome Measure Information:
Title
safety of S-equol
Description
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.
Time Frame
6 Weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell H Swerdlow, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
S-Equol in Alzheimer's Disease (SEAD) Trial
We'll reach out to this number within 24 hrs