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Trial record 2 of 2 for:    S-equol | Alzheimer Disease

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

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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

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
Alzheimer's Disease 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: S-Equol in Alzheimer's Disease (SEAD) Trial
Study Start Date : July 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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 Name: AUS-131

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142777


Locations
United States, Kansas
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

Responsible Party: Russell Swerdlow, MD, Gene and Marge Sweeney Professor of Neurology, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02142777     History of Changes
Other Study ID Numbers: STUDY00001228
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016

Keywords provided by Russell Swerdlow, MD, University of Kansas Medical Center:
S-equol
COX activity

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Equol
Dementia
Tauopathies
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs