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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT01404169
Eligibility Criteria:
Inclusion Criteria
* Written informed consent (IC) will be obtained from the subject (if possible) or from the subject's legal guardian or legal representative prior to beginning screening activities.
* Subject age range: male and female subjects 50 to 90 years of age, inclusive
* Diagnosis: diagnostic evidence of probable Alzheimer's Disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* MMSE 1 to 12 inclusive, at both Screening and Baseline
* SIB less than or equal to 90 and greater than or equal to 10 at both Screening and Baseline
* Comorbid medical conditions must be clinically stable prior to Baseline, unless otherwise specified.
Exclusion Criteria
* Subjects with a known history of disorders that affect cognition or the ability to assess cognition, but are distinguishable from AD
* Evidence of focal disease to account for dementia on any cranial image MRI or CT.
* Subjects with dementia complicated by other organic disease or AD with delirium according to DSM-IV criteria
* Subjects who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed
* Illiteracy prior to AD
* Subjects who are unwilling or unable to fulfill the requirements of the study
* Treatment with another cholinesterase inhibitor and/or memantine in the 3 months prior to Screening
* Subjects with a poor response (tolerability) to prior exposure to donepezil
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT01404169
Study Brief:
Protocol Section:
NCT01404169