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:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT00693004
Eligibility Criteria:
Inclusion Criteria:
* Men or Women with a clinical diagnosis of Probable AD
* MMSE score 16 to 24 inclusive
* Age \>50 and \<90 years
* Brain CT or MRI scan Consistent with a primary diagnosis of AD within 12 months
* Neurological examination without focal deficits (excluding changes attributable to peripheral nervous system disease, trauma or congenital birth deficits)
* No history or evidence of any other CNS disorder that could be interpreted as a cause of dementia
* No diagnosis of vascular dementia
* No history of significant psychiatric illness such as schizophrenia or bipolar affective disorder. Subjects with major depressive disorder on a stable dose of an antidepressant for \>6 months may be eligible
* No evidence of the following: current vitamin B12 deficiency, positive syphilis serology, positive HIV test, or abnormalities in thyroid function
* No cognitive rehabilitation within 6 months of the study
* Subject has a regular caregiver willing to attend all study visits
* Signed informed consent by the subject (and legal guardian, if applicable)
Exclusion Criteria:
* No history of drug or alcohol abuse
* No clinically significant laboratory abnormalities or medical history
* No investigational drug within 30 days of Randomization
* Intolerance or allergy to cholinesterase inhibitors
* Cannot have been on cholinesterase inhibitors for AD for \> 2 years
* If have been on cholinesterase inhibitors for \< 2 years, must have been discontinued \>= 2 months prior to randomization
* Cannot have received memantine within 2 months
* No clinically significant ECG abnormalities prior to randomization
* No history of uncontrolled seizure disorder within 12 months
* Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine
* No history of malignancy within 3 years of randomization
* Women cannot be pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT00693004
Study Brief:
Protocol Section:
NCT00693004