NCT00051402

Brief Summary

The purpose of this study is to investigate whether soy-derived phytoestrogens taken as dietary supplements improve memory function in postmenopausal women who have experienced early memory decline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_2

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

Study Start

First participant enrolled

December 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2003

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2003

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

October 26, 2007

Status Verified

October 1, 2007

First QC Date

January 9, 2003

Last Update Submit

October 24, 2007

Conditions

Memory LossPostmenopause

Keywords

PostmenopausalMemory LossCognitionPhytoestrogens

Interventions

IsoflavonesDRUG

Eligibility Criteria

Age62 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women
  • Mild memory or cognitive decline that does not meet the criteria for probable dementia
  • Exlcusion Criteria
  • Hormone replacement therapy within 2 months prior to study entry
  • Psychiatric medications within 30 days prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267-0559, United States

Location

MeSH Terms

Conditions

Memory Disorders

Interventions

Isoflavones

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Robert Krikorian, PhD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 9, 2003

First Posted

January 15, 2003

Study Start

December 1, 2002

Study Completion

August 1, 2007

Last Updated

October 26, 2007

Record last verified: 2007-10

Locations

US(1)