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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT04129060
Eligibility Criteria:
Inclusion Criteria:
* Women aged 50-70 years
* Postmenopausal
* Nonsmokers
* Not taking hormone therapy, selective serotonin uptake inhibitors (SSRIs(, phytoestrogens, selective estrogen receptor modulators (SERMS), or antiestrogen medications and will be at least one year without such treatment
* Physically healthy
* No cardiovascular disease other than mild hypertension. Subjects will also not have current untreated or unremitted Axis I or II psychiatric or cognitive disorders (see screening below).
* Intelligence quotient (IQ) in the normal range \>80
* Normal neuropsychological test performance
Exclusion Criteria:
* Mild Cognitive Impairment (MCI) or dementia - Montreal Cognitive Assessment \<26, Mattis Dementia Rating Scale \<130, and Global Deterioration Scale \>2
* History of cancer treatment with cytotoxic and/or ongoing (current) maintenance targeted chemotherapy
* Blood pressure \> 160/100 (untreated)
* Untreated thyroid disease
* Significant cardiovascular disease
* Asthma or chronic obstructive pulmonary disease (COPD)
* Active peptic ulcer
* Hyperthyroidism
* Epilepsy
* Current untreated or unremitted Axis I psychiatric disorders
* Use of medications that are on our prohibited medications list
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT04129060
Study Brief:
Protocol Section:
NCT04129060