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Isoflavones
Equol for Cognitive Impairment (ACE Trial)
Phase 2
Recruiting
Led By Akira Sekikawa, MD, PhD, PhD
Research Sponsored by Akira Sekikawa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline in cognitive score measured by the pacc-5 at 24 months
Awards & highlights
ACE Trial Summary
This trial will test if taking the dietary supplement Equol can slow progression of age-related stiffening of arteries & memory decline. Recruiting participants at 3 universities.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of Equol may include reactions similar to those experienced with soy products due to its plant-based origin. Specific side effects have not been listed but could relate to the estrogen-like activity of the compound.
ACE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline in cognitive score measured by the pacc-5 at 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline in cognitive score measured by the pacc-5 at 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in arterial stiffness
Secondary outcome measures
Change in cognitive score measured by the Preclinical Alzheimer's Cognitive Composite-5 (PACC-5) score
Change in cognitive score measured by the Preclinical Alzheimer's Cognitive Composite-5 (PACC-5) score.
Change in white matter lesion (WML) volume percent
Other outcome measures
Change in NIH Toolbox (NIH-TB) cognition battery score
Change in select plasma biomarkers
Change in ultrasound measurements of carotid artery
+1 moreSide effects data
From 2016 Phase 2 trial • 116 Patients • NCT009623903%
Hypersensitivity
3%
Pain in extremity
3%
Dyspnoea
3%
Blood pressure increased
3%
Low density lipoprotein increased
3%
Joint swelling
3%
Dizziness
3%
Depressed mood
3%
Libido decreased
3%
Vision Blurred
3%
Gastro-oesophageal reflux disease
3%
Pyrexia
3%
Paraesthesia of genital male
3%
Prostatomegaly
3%
Prostatic specific antigen increased
3%
Haematuria
3%
Erectile dysfunction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo BID
S-equol 150 mg BID
S-equol 50 mg BID
S-equol 10 mg BID
ACE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Equol ArmExperimental Treatment1 Intervention
S-equol - 10 mg per day tablet for 24 months.
Group II: Placebo ArmPlacebo Group1 Intervention
10 mg per day for 24 months of tablets that will be of the same size/shape/color as the experimental tablet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
S-equol
2017
Completed Phase 2
~590
Find a Location
Who is running the clinical trial?
Akira SekikawaLead Sponsor
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,485 Total Patients Enrolled
32 Trials studying Cognitive Decline
22,689 Patients Enrolled for Cognitive Decline
Akira Sekikawa, MD, PhD, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
1,027 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to be assigned randomly to either the treatment or placebo group.I cannot lay on my back for 30-60 minutes.I have an aneurysm in my abdomen or chest.I have a personal or family history of breast cancer.My doctor thinks this study might be risky or not good for me.I weigh 300 lbs or more.I have depression that has not been treated.I am currently being treated for blood clots in my lungs or legs.I have had a heart attack or a procedure on my heart in the last 6 months.I have atrial fibrillation.I have heart failure.I am between 65 and 85 years old and of European or African American descent.I am currently receiving hemodialysis.I am currently on estrogen replacement therapy.I have had surgery to clear a blocked artery in my neck or have peripheral artery disease.I have not had a stroke, neurological disorders, bipolar disease, recent cancer treatment, head trauma, or conditions that prevent MRI use.I have an inflammatory bowel disease.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Arm
- Group 2: Equol Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there certain demographics which are more advantageous for this medical trial?
"This medical trial is inviting 400 participants age 65 - 85 with arterial stiffness to participate."
Answered by AI
How secure is Equol Arm in regards to patient safety?
"Assessing Equol Arm's safety on a 1 to 3 scale, our team at Power gave it a 2 rating. This is due to preliminary evidence of its security, however no efficacy data has been collected."
Answered by AI
Are participants still welcome to join this research initiative?
"As per the clinicaltrials.gov records, this particular medical research is not accepting individuals at present. It was first posted on February 28th 2023 and its last update occurred on February 13th of the same year. Nevertheless, there are 572 other studies that are currently open to enrollment from prospective volunteers."
Answered by AI
Are individuals aged 40 or above eligible for enrolment in this experiment?
"To be included in this clinical trial, the patient must be between 65 and 85 years old. There are 22 studies for people under 18 and 537 trials that accommodate seniors."
Answered by AI
Who else is applying?
What site did they apply to?
Emory University
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
Just diagnosed with chronic microangiopathic ischemic disease moderate to severe for age and want to know more. How can I keep it from progressing.
PatientReceived 2+ prior treatments
I've KNOWN FOR a few years that I have WMD, but none of my doctors have suggested anything to help it. I was in physical Therapy for over a year but Kaiser Permanente stopped that. Since then I cannot walk without a cane or a walker. I hope to start PT again soon. I don't seem to have much cognitive impairment beyond most people my age (74), but I'm afraid of the future. If I am the kind of patient you are looking for, I would be happy to join,.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long do visits take? Will I be informed of all results of testing? Can these results be sent to my Primary Care?
PatientReceived 2+ prior treatments
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