Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT00097058
Eligibility Criteria:
Inclusion Criteria:
* Women between the ages of 45 and 65
* Currently on hormone replacement
* One year or more post complete cessation of menses
* Willing to sign the Human Subject Protection Consent form prior to enrollment in the study
* Willing to be randomized to continue or discontinue estrogen therapy
* Adequately visually and auditorially acute to allow neuropsychological testing
* Beyond 8 years of educational achievement to allow adequate neuropsychological testing
* Willing to undergo brain imaging
* At risk for cognitive decline, as defined by one or more of the following: Personal or family history of mood disorder, Hypothyroidism, Diabetes, Family history of Alzheimer's, APOE-4 allele
Exclusion Criteria:
* Diagnosis of possible or probable Alzheimer's disease or dementia
* Cerebrovascular disease or uncontrolled hypertension (systolic BP \>170 or diastolic BP \>100)
* History of myocardial infarction within previous year or unstable heart disease
* History of significant liver disease, pulmonary disease, or current cancer
* Contraindication for MRI (metal in body, claustrophobia, etc.)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT00097058
Study Brief:
Protocol Section:
NCT00097058