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Trial record 2 of 26 for:    S-equol

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02142777
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : August 16, 2016
Sponsor:
Collaborator:
Ausio Pharmaceuticals, LLC
Information provided by (Responsible Party):
Russell Swerdlow, MD, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE May 8, 2014
First Posted Date  ICMJE May 20, 2014
Last Update Posted Date August 16, 2016
Study Start Date  ICMJE July 2014
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S-Equol in Alzheimer's Disease (SEAD) Trial
Official Title  ICMJE S-Equol in Alzheimer's Disease (SEAD) Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: S -Equol
    We will determine if the intervention (S-equol) alters platelet mitochondria COX activity.
    Other Name: AUS-131
  • Drug: Placebo
    The placebo has no active ingredients but is made to look like the study drug.
Study Arms  ICMJE 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.
Interventions:
  • Drug: S -Equol
  • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2014)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02142777
Other Study ID Numbers  ICMJE STUDY00001228
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Russell Swerdlow, MD, University of Kansas Medical Center
Study Sponsor  ICMJE Russell Swerdlow, MD
Collaborators  ICMJE Ausio Pharmaceuticals, LLC
Investigators  ICMJE
Principal Investigator: Russell H Swerdlow, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP