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NCT05741060 · ClinicalTrials.gov registry record · Phase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
A Phase 2 study of Cognitive Decline and Arterial Stiffness, sponsored by Akira Sekikawa.
- Active
- Registry status
- Phase 2
- Development phase
- 369
- Enrollment target
- 3
- Study locations
NCT05741060: Active Phase 2 study of Cognitive Decline and Arterial Stiffness, sponsored by Akira Sekikawa.
NCT05741060 is a Phase 2 study of Cognitive Decline and Arterial Stiffness that is active but no longer recruiting, run by Akira Sekikawa. The registered enrollment target is 369 participants, below the 1,143-participant average among 61 other Cognitive Decline trials with a reported enrollment target (68% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05741060, a Phase 2 study of Cognitive Decline and Arterial Stiffness, is active but no longer recruiting, sponsored by Akira Sekikawa.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 369 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Arterial stiffness describes the rigidity of the arterial wall and is a significant predictor of cognitive decline. Arterial stiffness will be measured by pulse wave velocity (m/s) with a SphygmoCor device (Sydney, Australia). The range of pulse wave velocity is from 5 to 20 m/s.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG S-equol
Study Locations (3)
Georgia
- Emory University - Atlanta
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 369 participants |
| Start Date | 2023-06-29 |
| Est. Completion | 2027-01-30 |
| Phase | Phase 2 |
What the registry record for NCT05741060 still lists
NCT05741060 is an interventional study that assigns participants to a tested intervention. The registered 369 participants enrollment target is mid-sized for trials with a published cap, below the 1,143-participant average among 61 other Cognitive Decline trials with a reported enrollment target (68% lower).
The record links to 3 conditions, with Cognitive Decline appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05741060 reports a single indexed study location in Georgia, North Carolina, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05741060 about?
NCT05741060 is a clinical study titled "Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers". 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 me...
What is the current status of trial NCT05741060?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 369 participants. The study started on 2023-06-29. Estimated completion is 2027-01-30.
What conditions does trial NCT05741060 study?
This clinical trial studies the following conditions: Cognitive Decline, Arterial Stiffness, White Matter Lesions.
What interventions are being tested in trial NCT05741060?
The interventions under investigation include: Placebo (DRUG), S-equol (DRUG).
Who is sponsoring clinical trial NCT05741060?
This trial is sponsored by Akira Sekikawa, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05741060 being conducted?
This trial has 3 study locations across Georgia, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05741060's enrollment target sits among peer trials
369 14th of 61 higher than 48 of 61 other Cognitive Decline trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cognitive Decline trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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