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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
S-equol
Placebo
Sponsored by
Russell Swerdlow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical and Translational Science Unit
  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

S-equol

Placebo

Arm Description

Participants will receive S-equol 50mg twice daily for one month

Participants will receive matched placebo pill to take twice daily for one month

Outcomes

Primary Outcome Measures

Difference in cytochrome oxidase/citrate synthase (COX/CS) activity
Measured as the mean intra-individual COX/CS activity

Secondary Outcome Measures

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)
Montreal Cognitive Assessment (MoCA) Determine if S-equol influences participant scores.
Scale range: 0-30 (higher score indicates better result)
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)
Logical Memory Test (LMT) - immediate and delayed recall Determine if S-equol influences participant scores.
Scale range: 0-25 (higher score indicates better result)
Stroop Test Determine if S-equol influences participant scores.
Scale range: 0-unlimited (higher score indicates better result)
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.

Full Information

First Posted
March 29, 2017
Last Updated
August 11, 2021
Sponsor
Russell Swerdlow
Collaborators
Ausio Pharmaceuticals, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03101085
Brief Title
S-Equol in Alzheimer's Disease 2 Trial
Acronym
SEAD2
Official Title
S-Equol in Alzheimer's Disease 2 (SEAD2) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Russell Swerdlow
Collaborators
Ausio Pharmaceuticals, LLC

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S-equol
Arm Type
Experimental
Arm Description
Participants will receive S-equol 50mg twice daily for one month
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matched placebo pill to take twice daily for one month
Intervention Type
Drug
Intervention Name(s)
S-equol
Other Intervention Name(s)
AUS-131
Intervention Description
S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules matched in size and color to S-equol capsules
Primary Outcome Measure Information:
Title
Difference in cytochrome oxidase/citrate synthase (COX/CS) activity
Description
Measured as the mean intra-individual COX/CS activity
Time Frame
One Month
Secondary Outcome Measure Information:
Title
Safety laboratories evaluation and participant/study partner reporting of symptoms or adverse events
Description
Measured as adverse events reported over the course of the study (safety labs, physical and neurological exams, vital signs, signs and symptoms)
Time Frame
Month 4
Title
Montreal Cognitive Assessment (MoCA) Determine if S-equol influences participant scores.
Description
Scale range: 0-30 (higher score indicates better result)
Time Frame
Months 2, 3, 4
Title
Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11) Determine if S-equol influences participant scores.
Description
Scale range: 0-70 (lower score indicates better result)
Time Frame
Months 2, 3, 4
Title
Logical Memory Test (LMT) - immediate and delayed recall Determine if S-equol influences participant scores.
Description
Scale range: 0-25 (higher score indicates better result)
Time Frame
Months 2, 3, 4
Title
Stroop Test Determine if S-equol influences participant scores.
Description
Scale range: 0-unlimited (higher score indicates better result)
Time Frame
Months 2, 3, 4
Title
Pattern of COX activity changes while on the active treatment versus placebo arms of this crossover study.
Description
Pts will categorically be defined as responders or non-responders depending on the slope of COS/CS activity change.
Time Frame
Months 1, 3, 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Swerdlow, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Translational Science Unit
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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S-Equol in Alzheimer's Disease 2 Trial

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