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
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: S -Equol Drug: Placebo||Phase 1|
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|
|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|
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
The placebo has no active ingredients but is made to look like the study drug.
- 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.
- 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.
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
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Russell H Swerdlow, MD||University of Kansas Medical Center|