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 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT01478633
Eligibility Criteria:
Inclusion Criteria:
* Have diagnosis of probable Alzheimer's disease (AD) in accordance with the diagnostic criteria of NINCDS-ADRDA study group
* Have an MMSE score of 10 to 22 inclusive at screening
* Have taken donepezil stably at 5 mg/day for more than 6 months before screening
* Have progression (worsening) of impaired cognitive function 6 months or longer before screening
* Be considered medically stable by the investigator on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
* Be medically stable on the basis of clinical laboratory tests performed at screening
Exclusion Criteria:
* Has any concurrent neurodegenerative diseases manifesting dementia other than Dementia of Alzheimer's type
* Has suspected impaired cognitive function due to a variety of causes
* Has significant health disorders or diseases according to the investigators' detailed criteria
* Has had major surgery within 52 weeks of screening, or will not have fully recovered from surgery, or planned surgery during the time the subject is expected to participate in the study
* Is a woman who is pregnant, or breast-feeding, or planning to become pregnant or is a man who plans to father a child while enrolled in this study
* Has a history of severe drug allergy or severe drug hypersensitivity
* Has a history of drug or alcohol abuse
* Used another investigational drug within 90 days of screening
* Used anti-dementia drugs marketed or being developed other than donepezil or medications containing the same active ingredients within 6 months of screening
* Is considered as ineligible by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01478633
Study Brief:
Protocol Section:
NCT01478633