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Cognitive Decline / White Matter Lesions / Arterial Stiffness · Phase 2 Trial
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 2 randomized, placebo-controlled trial of equol supplementation in healthy volunteers, designed to assess effects on arterial stiffness, white matter lesions, and cognitive decline over 24 months. No results have been posted in this registry record; the trial is actively enrolling or recently completed enrollment but outcome data are not yet available.
Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Prevention purpose. Arterial Stiffness, White Matter Lesions, Cognitive Decline; age from 65 Years; to 85 Years; accepts healthy volunteers. Intervention: Equol Arm. Compared with: Placebo Arm — Placebo Comparator. n = 369. 3 sites: United States.
This is a planned Phase 2 randomized, placebo-controlled trial of equol supplementation in healthy volunteers, designed to assess effects on arterial stiffness, white matter lesions, and cognitive decline over 24 months. No results have been posted in this registry record; the trial is actively enrolling or recently completed enrollment but outcome data are not yet available.
This is a registry record with no results posted; no efficacy or safety outcomes are reported
The source did not state who this applies to in practice.
This is a Phase 2 interventional trial registration with no results posted; the study is active but not yet recruiting and outcomes have not been reported.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05741060). This is a study registration, not published results. Lead sponsor: Akira Sekikawa. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 369 participants (ACTUAL). Conditions: Arterial Stiffness, White Matter Lesions, Cognitive Decline. Interventions: DRUG: S-equol; DRUG: Placebo. Primary outcome measures: Change in arterial stiffness , Change from baseline in arterial stiffness at 12 months; Change in arterial stiffness , Change from baseline in arterial stiffness at 24 months. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.