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 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT00154635
Eligibility Criteria:
Inclusion Criteria:
1. Male or post menopausal female patients aged ≧50 years old;
2. The informed consent must be signed by the patient and co-signed by their proxy or principal caregivers before undergoing any study procedures;
3. Probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Alzheimer's dementia and related disorder (NINCDS-ADRDA)
4. Patients with Mini-Mental State Examination (MMSE) scores of 12\~24
5. Patients with Clinical Dementia Rating (CDR)in mild (CDR = 1) and moderate (CDR = 2) AD
6. Cranial computed tomography (CT) or brain magnetic resonance imaging (MRI) must be within the past 12 months;
7. Patients must be able to complete baseline assessments;
8. An eligible principal caregiver must be able to accompany the patient to all scheduled visits;
9. Patients currently taking ChEIs such as donepezil, rivastigmine, or galantamine are allowed if the dose has been unchanged for the last 3 months before the study entry.
Exclusion Criteria:
1. Patients with history of severe systemic disease such as coronary artery disease, myocardial infarct, progressive heart failure, chronic obstructive pulmonary disease within the past 1 year;
2. Patients with hepatic and renal insufficiency (ALT、AST 3 times above normal range; serum creatinine 2 times above normal range), diabetic patients with poor control of blood sugar (HbA1c\>8.5) at study entry;
3. Patients with central nervous system disease other than AD such as cerebral vascular disease, Parkinson's disease, epilepsy, traumatic brain injury, central nervous system infection, and alcoholic encephalopathy;
4. Patients with concurrent psychosis or mood disorder (Hamilton depression scale score \> 17);
5. Patients diagnosed cancer and treated within the past two years (except for non-invasive skin cancer);
6. Patients with general medical conditions, which may confound the results of the study, pose additional risk or preclude evaluation and assessments in this study as judged by the investigator;
7. Patients currently treated with any prohibited medications (listed in Concomitant Treatment section) are not able to fulfill the 2 week-washout period;
8. Participation in another study within the last 30 days;
9. Females who are within two years of their menopause unless proved not pregnant (determined by urine test);
10. Dementia caused by other etiology as indicated by clinically significant abnormal Vit B12, folic acid, or thyroid function tests.
11. Patients with neurosyphilis confirmed by CSF STS/TPHA;
12. The neuroimage CT or MRI could not be compatible with the diagnosis of probable AD as stated in the NINCDS criteria;
13. Patients with a Hachinski score (Appendix 5) above 3 are excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00154635
Study Brief:
Protocol Section:
NCT00154635