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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT00567060
Eligibility Criteria:
Inclusion Criteria:
* male/female between 50 and 89 years (inclusive)
* declining cognitive function of at least 3 months duration interfering with complex activities of daily living
* normal basic activities of daily independent living
* Clinical Dementia Rating scale score equal to 0.5
* score at least one point above the lowest possible score on 7 out of 8 tests in the cognitive battery at both Selection Visit and Baseline Visit
Exclusion Criteria:
* general anesthetics within 3 months of selection visit
* history of severe allergic drug reaction(s)
* history of drug or alcohol dependence (DSM IV defined) within the last 12 months
* any drug prescribed to activate cerebral metabolism, taken within 1 week of screening or/and concomitantly
* concomitant intake of anticoagulent medications
* concomitant intake or intake within 1 week before screening of drug that might affect cognitive function or central nervous system
* history of dementia, psychiatric or neurological disorders, mental retardation, learning disabilities and stroke
* current depression
* impaired renal function, thyroid function or neurological degeneration
* any gastrointestinal dysfunction that might interfere with the absorption or elimination of the study drug
* insulin-dependant diabetes mellitus
* bleeding disorders or disturbance in hemostatic function.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
89 Years
Study:
NCT00567060
Study Brief:
Protocol Section:
NCT00567060