Alzheimer's Disease
Conditions
Keywords
S-equol, COX activity
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.
Interventions
DRUGS -Equol
We will determine if the intervention (S-equol) alters platelet mitochondria COX activity.
DRUGPlacebo
The placebo has no active ingredients but is made to look like the study drug.
Sponsors
Ausio Pharmaceuticals, LLC
Russell Swerdlow, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| platelet mitochondria cytochrome oxidase (COX) activity | 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
| Measure | Time frame | Description |
|---|---|---|
| safety of S-equol | 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. |
Countries
United States
Outcome results
None listed