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S-Equol in Alzheimer's Disease 2 Trial (SEAD2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03101085
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : March 30, 2020
Ausio Pharmaceuticals, LLC
Information provided by (Responsible Party):
Russell Swerdlow, MD, University of Kansas Medical Center

Brief Summary:
By doing this study researchers hope to learn if S-equol, a compound that acts like estrogen in the body, causes an increase in mitochondrial activity. Researchers also hope to determine the safety and tolerability of a therapeutic dose of S-equol and whether or not it influences cognition.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: S-equol Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: S-Equol in Alzheimer's Disease 2 (SEAD2) Trial
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : November 30, 2020

Arm Intervention/treatment
Experimental: S-equol
Participants will receive S-equol 50mg twice daily for one month
Drug: S-equol
S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules
Other Name: AUS-131

Placebo Comparator: Placebo
Participants will receive matched placebo pill to take twice daily for one month
Other: Placebo
Placebo capsules matched in size and color to S-equol capsules

Primary Outcome Measures :
  1. Difference in cytochrome oxidase/citrate synthase (COX/CS) activity [ Time Frame: One Month ]
    Measured as the mean intra-individual COX/CS activity

Secondary Outcome Measures :
  1. Safety laboratories evaluation and participant/study partner reporting of symptoms or adverse events [ Time Frame: Month 4 ]
    Measured as adverse events reported over the course of the study (safety labs, physical and neurological exams, vital signs, signs and symptoms)

  2. Montreal Cognitive Assessment (MoCA) Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-30 (higher score indicates better result)

  3. Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11) Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-70 (lower score indicates better result)

  4. Logical Memory Test (LMT) - immediate and delayed recall Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-25 (higher score indicates better result)

  5. Stroop Test Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-unlimited (higher score indicates better result)

  6. Pattern of COX activity changes while on the active treatment versus placebo arms of this crossover study. [ Time Frame: Months 1, 3, 4 ]
    Pts will categorically be defined as responders or non-responders depending on the slope of COS/CS activity change.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have a diagnosis of Alzheimer's Disease (AD)
  • Have a study partner who has a close relationship with the participant and will attend study visits with the participant
  • Do not possess an Alkylphenol ethoxylates 4 (APOE4) variant of the APOE gene
  • Speak English as their primary language
  • Have not had any medication changes within the past 30 days

Exclusion Criteria:

  • Reside in a nursing home or dementia special care unit
  • Have a potentially confounding, serious medical risk such as insulin-requiring diabetes, any history of cancer that required a chemotherapy or radiation therapy intervention within the past 5 years, or a recent cardiac event
  • Have any clinically significant abnormal safety laboratory values at the SEAD2 screening visit
  • Have any clinically significant abnormal findings on vital signs measurements, or on physical or neurological examination at the SEAD2 screening visit
  • Use any type of systemic estrogen or testosterone replacement therapy
  • Has participated in another clinical trial or received any investigational drug or investigational therapy within 30 days before the screening visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03101085

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Contact: Annette Becker (913) 945-7674
Contact: Rebecca Bothwell (913) 945-5033

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United States, Kansas
Clinical and Translational Science Unit Recruiting
Fairway, Kansas, United States, 66205
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Russell Swerdlow, MD
Ausio Pharmaceuticals, LLC
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Principal Investigator: Russell Swerdlow, MD University of Kansas Medical Center
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Responsible Party: Russell Swerdlow, MD, Professor, University of Kansas Medical Center Identifier: NCT03101085    
Other Study ID Numbers: SEAD2
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs