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

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: S-equol; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Fairway, Kansas, United States, 66205
      • Clinical and Translational Science Unit
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in cytochrome oxidase/citrate synthase (COX/CS) activity	Measured as the mean intra-individual COX/CS activity	One Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety laboratories evaluation and participant/study partner reporting of symptoms or adverse events	Measured as adverse events reported over the course of the study (safety labs, physical and neurological exams, vital signs, signs and symptoms)	Month 4
Montreal Cognitive Assessment (MoCA) Determine if S-equol influences participant scores.	Scale range: 0-30 (higher score indicates better result)	Months 2, 3, 4
Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11) Determine if S-equol influences participant scores.	Scale range: 0-70 (lower score indicates better result)	Months 2, 3, 4
Logical Memory Test (LMT) - immediate and delayed recall Determine if S-equol influences participant scores.	Scale range: 0-25 (higher score indicates better result)	Months 2, 3, 4
Stroop Test Determine if S-equol influences participant scores.	Scale range: 0-unlimited (higher score indicates better result)	Months 2, 3, 4
Pattern of COX activity changes while on the active treatment versus placebo arms of this crossover study.	Pts will categorically be defined as responders or non-responders depending on the slope of COS/CS activity change.	Months 1, 3, 4

Collaborators and Investigators

• Sponsor: Russell Swerdlow
• Collaborators: Ausio Pharmaceuticals, LLC
• Investigators: Principal Investigator: Russell Swerdlow, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens, Non-Steroidal; Estrogens; Phytoestrogens; Equol
• Other Study ID Numbers: SEAD2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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