Alzheimer's Disease
Conditions
Keywords
Oxaloacetate, OAA, AD, Alzheimer's Disease
Brief summary
By doing this study, researchers hope to learn how much oxaloacetate (OAA) ends up in the blood after OAA capsules are swallowed, and to assess whether persons with Alzheimer's disease who take OAA for one month have any side-effects.
Interventions
DIETARY_SUPPLEMENTOxaloacetate (OAA)
Sponsors
Russell Swerdlow, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet criteria for Mild or Moderate AD * Have a study partner * Speak English as primary language.
Exclusion criteria
* Absence of a 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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between oral OAA intake and plasma levels | Change from dose to 30, 45, 60, 75, 90, 105, 120, 135, 150, and 240 minutes after dosing | Baseline blood sample will be obtained before 100 mg OAA is administered. Blood samples to be drawn every 15 minutes starting 30 minutes after OAA administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety of OAA in study participants | Change from Baseline to Month 1 | We will evaluate weights, blood counts, electrolytes, liver function tests, insulin levels, and plasma amino acid levels in subjects exposed to OAA for 1 month. These multiple measures will be used to generate a composite safety outcome measure. |
Countries
United States
Outcome results
None listed