This part shows the effect of a recent NIH-requirement that trials provide results and support needs of patients. This is an NIH-funded. trial.The main purpose of the ACE Trial (short for Arterial Stiffness, Cognition and Equol) is to determine if taking Equol, a plant-based supplement, could slow the progression of stiffening of the arteries, small blood vessel disease in the brain and memory decline.
The ACE Trial will recruit a total of 400 African American and Caucasian participants between the ages of 65 and 85 from three locations in the US (200 at the University of Pittsburgh, Pittsburgh, PA; 100 from Emory University in Atlanta, GA; and 100 at Wake Forest University in Winston-Salem, NC)...This study involves an initial phone call and screening visit to find out if you are eligible. We will ask you to complete 7 clinic visits over a two year period so that we can evaluate any changes.
As part of the study, we will complete several non-invasive tests like measuring your blood pressure and heart rate, height and weight, and doing tests of walking and thinking. We will collect a sample of your blood, urine and stool. If eligible after screening, participants will have more visits over 2 years and several phone calls.
Participants will be asked to have a magnetic resonance imaging (MRI) scan. MRI scans are not invasive and do not use radiation. We will also do an assessment of arterial stiffness and an ultrasound scan of your carotid arteries, both of which are non-invasive exams. We will ask ACE participants to be randomly assigned by a computer (by chance, like the flip of a coin) to a group that takes 10 mg Equol daily or to a group that takes a daily placebo.
I have no stake in this trial, and know much less than many about the benefit of soy for Apoe4 carriers. But what impresses me about this trial is that it's looking at the prevention of vascular disease and white matter lesions, a key issue for ApoE 4 carriers, using a soy-based derivative designed to be more bio-available to White and Black populations, who in prior studies often lacked the genetic ability to get the benefit of soy.You will receive results of some assessments, will be compensated for your time and, if needed, transportation can be provided at no cost.
Primary and secondary outcomes are listed in the Clinical Trials.gov site, linked below, and are excerpted here:
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers (ACE)Primary:
- Change in arterial stiffness at 12 and 24 months
- Change in white matter lesion (WML) volume percent at 24 months
- Change in cognitive score measured by the Preclinical Alzheimer's Cognitive Composite-5 (PACC-5) score at 12 and 24 months. The PACC-5 is a composite neuropsychological measure optimized to detect subtle changes over time in cognitively unimpaired older adults.
- Change in NIH Toolbox (NIH-TB) cognition battery, comprised of computerized tests of fluid [i.e. flexible] and crystallized [i.e. well-learned]cognitive abilities, via proctored iPad administration. score at 12 & 24 months
- Change in ultrasound measurements of carotid artery at 24 months.
- Plasma biomarkers of inflammation and endothelial function (C-reactive protein, intracellular adhesion molecule, vascular cell adhesion molecule, glial fibrillary acidic protein, neurofilament light) as well as amyloid-β40, amyloid-β42 and phosphorylated tau 181 will be measured at 24 months.