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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT01928420
Eligibility Criteria:
Inclusion Criteria:
* NINCDS/ADRDA criteria for probable AD
* MMSE between 12-27
* Treatment with a cholinesterase inhibitor or an NMDA (N-methyl-D-asparate) antagonist with stable dose for at least 12 weeks
* Home monitoring available for supervision of medications
* Caregiver available to accompany patient to all visits and willing to participate in study as informant
* Fluent in English or Spanish
* Medical stability for this study as confirmed by review of records, internist's physical exam, neurological exam, and laboratory tests
* Stable doses of non-excluded medication
* No evidence of hepatic insufficiency
* Able to swallow oral medications
* Ability to participate in the informed consent process
Exclusion Criteria:
* History of Diabetes Mellitus (OGTT criteria) requiring treatment with an excluded antidiabetic medication (see below) or history of hypoglycemia
* Active hepatic or renal disease
* Cardiac disease including history of congestive heart failure or current treatment for CHF; history of recent myocardial infarction
* Use of another investigational drug within the past two months
* History of clinically significant stroke
* History of seizure or head trauma with disturbance of consciousness within the past two years
* Major mental illness including psychotic disorders, bipolar disorder, or major depressive episode within the past two years Medication Exclusion
* Current use of oral hypoglycemic agents including sulfonylureas and meglintinides
* Current or past treatment with insulin for longer than two weeks
* Current use of drugs with significant anticholinergic or antihistaminic properties
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
95 Years
Study:
NCT01928420
Study Brief:
Protocol Section:
NCT01928420