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 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT00523666
Eligibility Criteria:
Inclusion Criteria:
* male of female patients aged ≥ 55years, fulfilling criteria of the National Institute of Neurological and Communicative Disease and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) for the diagnosis of clinically probable AD
* MMSE score \> 16
* no evidence for other psychiatric axis I disorders according to DSM- IV criteria
* no evidence for cerebrovascular disease (radiological confirmed), cardiac or cerebral infarct (three months before the study), thyroid disease and other neurodegenerative or neuroinflammatory disorders. No evidence for acute or unstable medical condition.
* no risk factors of hypertension, cardiac disease (e.g. angina pectoris, congestive heart failure, right bundle branch block, or arrhythmias), diabetes mellitus (stable within 3 months)
* no history of drug/alcohol abuse
* no history of panic attacks or claustrophobia (due to requirements of the MRI examinination)
* no surgical implants or non-fixed metallic particles
* patient has not taken a previously approved cholinesterase inhibitor or memantine, which has been discontinued at least 6 weeks prior to the Screening
* patient is able to provide written Informed Consent to participate study. If, at investigator's discretion, a patient is considered not to be capable to give legal consent, then written consent must also be obtained from the patient's legally acceptable representative.
Exclusion Criteria:
* no evidence of memory or other cognitive impairments, verified by clinical history and cognitive testing
* previous or current history of degenerative or ischemic disorders of the peripheral or central nervous system
* previous or current history of systemic disorders
* no ability to participate and no willing to give informed consent and comply with the study restrictions
* MMSE score \< 16 range
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
95 Years
Study:
NCT00523666
Study Brief:
Protocol Section:
NCT00523666