NCT02142777

Brief Summary

The purpose of this study is to determine if S-equol could benefit persons with Alzheimer's Disease (AD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

May 8, 2014

Last Update Submit

August 12, 2016

Conditions

Alzheimer's Disease

Keywords

S-equolCOX activity

Outcome Measures

Primary Outcomes (1)

  • platelet mitochondria cytochrome oxidase (COX) activity

    Activity will be identified by the percentage of subjects who show an increase in COX activity while on the active treatment as compared to the COX activity while on placebo.

    Change from Baseline to 6 Weeks

Secondary Outcomes (1)

  • safety of S-equol

    6 Weeks

Study Arms (1)

Investigational

EXPERIMENTAL

All study subjects will take a 10mg pill by mouth twice daily over a 6 week period. Subjects will receive either placebo or S -Equol. They will not know which they are receiving.

Drug: S -EquolDrug: Placebo

Interventions

S -EquolDRUG

We will determine if the intervention (S-equol) alters platelet mitochondria COX activity.

Also known as: AUS-131
Investigational
PlaceboDRUG

The placebo has no active ingredients but is made to look like the study drug.

Investigational

Eligibility Criteria

Age60 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Very mild (CDR 0.5) or mild (CDR 1) AD at time of last KU ADC assessment
  • Have a study partner
  • Speak English as primary language

You may not qualify if:

  • No viable study partner
  • Report a potentially confounding, serious medical risk such as type 1 diabetes, cancer, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)
  • Use any type of estrogen replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Equol

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoflavonesFlavonoidsChromonesBenzopyransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Russell H Swerdlow, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gene and Marge Sweeney Professor of Neurology

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 20, 2014

Study Start

July 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

US(1)