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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT03121118
Eligibility Criteria:
Inclusion Criteria:
All MCI participants:
1. Participant at the Pittsburgh Alzheimer's Disease Research Center, or other cognitive impairment studies.
2. Carry a current diagnosis of MCI
3. Have a family member or kin-like friend who also signs informed consent to participate
4. Female participants must be 5 years post menopausal by self-report
All family member participants:
1\) At least 18 years of age 2) Can read and write English
\-
Exclusion Criteria:
All MCI patient participants:
1. familial AD genetic mutation carriers (this group already has biomarker-derived knowledge of their dementia risk)
2. evidence of active, untreated primary psychiatric disorders defined as a CES-D (Depression Rating Scale) score of \>=16 or a Spielberger State Anxiety score of \>40 (to minimize the possibility of adverse events and to reduce any confounding influence of baseline mood)
3. Active suicidal ideation indicated via the Beck Scale for Suicidal Ideation and verified by clinician interview.
Participants with MCI and their primary participating family member:
1\) Inability to provide direct consent to the study based on performance on the University of San Diego Brief Assessment of Capacity to Consent (meaning, proxy consent will not be accepted).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03121118
Study Brief:
Protocol Section:
NCT03121118