Equol for Cognitive Impairment

(ACE Trial)

Recruiting at 2 trial locations

Overseen By Monica Love, MLIS

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Akira Sekikawa

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The ACE Trial, funded by the National Institute on Ageing/National Institutes of Health (NIH), is a multicenter clinical trial. The ACE Trial will determine if taking the dietary supplement Equol could slow the progression of stiffening of the arteries, small blood vessel disease in the brain and memory decline. Equol is a soy-based supplement that has plant estrogen-like compounds in it. Equol is a metabolite of soy isoflavone. Our studies in Japan and other studies suggest that Equol may slow mechanisms related to memory decline. No previous studies in the United States have tested the effect of Equol on these mechanisms or memory decline. Supplementation of Equol in the ACE Trial is approved by the Food and Drug Administration (FDA). Researchers at the University of Pittsburgh, Pittsburgh, Pennsylvania, Wake Forest University, Winston-Salem, North Carolina, and Emory University, Atlanta, Georgia, are recruiting participants. The ACE Trial will ask participants to complete 7 clinic visits over a two-year period. The participants are asked to take Equol tablets daily for 24 months. Clinic procedures include Pulse Wave Velocity (to measure arterial stiffness), Magnetic Resonance Imaging (MRI) of the brain and tests of awareness and thinking.

Research Team

Akira Sekikawa, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

Healthy volunteers aged 65-85, either European or African American, who can consent and are willing to be randomly assigned to a treatment group. Excluded are those with certain medical conditions like heart failure, untreated depression, severe allergies to soy isoflavones, recent cancer treatment or stroke, extreme obesity (BMI ≥40), or any condition that makes MRI unsafe.

Inclusion Criteria

I am willing to be assigned randomly to either the treatment or placebo group.

I am between 65 and 85 years old and of European or African American descent.

Individuals who are able to provide informed consent

Exclusion Criteria

Individuals with Quick Dementia Rating System (QDRS) score ≥ 6.0

White blood cell count <3,000 or >15,000

Individuals whose score for the Telephone Interview for Cognitive Status is 22 and below

Treatment Details

Interventions

• Equol (Isoflavones)
• Placebo (Behavioural Intervention)

Trial Overview The ACE Trial is testing if Equol, a dietary supplement derived from soybeans with estrogen-like effects, can slow down arterial stiffening and cognitive decline in healthy older adults. Participants will take Equol daily for two years and undergo regular clinic visits including MRI scans and memory tests.

Participant Groups

Group I: Equol Arm Experimental Treatment 1 Intervention

S-equol - 10 mg per day tablet for 24 months.

Group II: Placebo Arm Placebo Group 1 Intervention

10 mg per day for 24 months of tablets that will be of the same size/shape/color as the experimental tablet.

Who Is Running the Clinical Trial?

Akira Sekikawa

Lead Sponsor

Trials

1

Recruited

370+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+