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

• ClinicalTrials.gov Identifier: NCT03101085
• Recruitment Status: Completed
• First Posted: April 4, 2017
• Last Update Posted: August 13, 2021
• Sponsor: Russell Swerdlow
• Collaborator: Ausio Pharmaceuticals, LLC
• Information provided by (Responsible Party): Russell Swerdlow, University of Kansas Medical Center

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Primary Completion Date: March 1, 2021
• Actual Study Completion Date: March 1, 2021

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Kansas

Clinical and Translational Science Unit

Fairway, Kansas, United States, 66205

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

Russell Swerdlow

Ausio Pharmaceuticals, LLC

Investigators

• Principal Investigator: Russell Swerdlow, MD; University of Kansas Medical Center

More Information

• Responsible Party: Russell Swerdlow, Professor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT03101085
• Other Study ID Numbers: SEAD2
• First Posted: April 4, 2017
• Last Update Posted: August 13, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Equol; Phytoestrogens; Estrogens, Non-Steroidal; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs