S-Equol in Alzheimer's Disease 2 Trial

Alzheimer Disease Clinical Trial

— SEAD2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101085
• Other study ID #: SEAD2
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 5, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: August 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• S-equol
S-equol is an estrogen receptor ß (ERß) agonist. Provided in capsules

Other:
• Placebo
Placebo capsules matched in size and color to S-equol capsules

Locations

Country	Name	City	State
United States	Clinical and Translational Science Unit	Fairway	Kansas
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Russell Swerdlow	Ausio Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in cytochrome oxidase/citrate synthase (COX/CS) activity	Measured as the mean intra-individual COX/CS activity	One Month
Secondary	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
Secondary	Montreal Cognitive Assessment (MoCA) Determine if S-equol influences participant scores.	Scale range: 0-30 (higher score indicates better result)	Months 2, 3, 4
Secondary	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
Secondary	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
Secondary	Stroop Test Determine if S-equol influences participant scores.	Scale range: 0-unlimited (higher score indicates better result)	Months 2, 3, 4
Secondary	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