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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT01073228
Eligibility Criteria:
Inclusion Criteria:
* Subjects with Probable Alzheimer's disease
* Mini-Mental State Examination (MMSE) score of 14 to 24 inclusive at screening and a CDR-SB score ≥2 at the screening assessment
* Modified Hachinski Ischemic Score (mHIS) ≤4 at screening
* Female subjects are ≥1 year post-menopausal or are surgically sterile
* Caregiver available; if not living in the same household, caregiver sees subject at least four times each week
* Subject living at home, senior residential setting, or an institutional setting without the need for continuous nursing care
* General health status acceptable for participation in a 24 week clinical trial be administered
Exclusion Criteria:
General
* Participation in another therapeutic clinical trial within 30 days before Baseline
* Prior participation in an amyloid vaccination clinical study
* Inability to swallow capsules
* Likely inability to complete 24 week study
* Inability to be ≥75% compliant with single-blind placebo run-in medication
* Inability to adequately perform cognitive tests
* History of significant cardiovascular disease
* Major depression
* Psychosis
* History of stroke within 18 months of screening
* Head trauma
* Inability to perform any screening or baseline evaluations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT01073228
Study Brief:
Protocol Section:
NCT01073228