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 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT00013650
Eligibility Criteria:
* INCLUSION CRITERIA:
Subjects must have a diagnosis of probable Alzheimer's disease according to DSM-IV and NINDS criteria.
Subjects must have mild-moderate severity of dementia according to the Clinical Dementia Rating Scale at the time of study.
They must also have the ability to assign a DPA or have already assigned a DPA and give informed consent for this medication trial and be willing to undergo repeat lumbar punctures for the assessment of cerebrospinal fluid.
EXCLUSION CRITERIA:
Severe dementia (CDR score greater than 2).
Diagnosis of probable vascular dementia.
Inability to give assent for participation or designate a durable power of attorney.
Medication history of cytotoxic drug therapy for more than 2 weeks during the 10 weeks prior to study entry, for more than 10 weeks at any time, or for anytime during the 30 day period prior to study entry.
Recent use of continuous (more than 3 doses per week) nonsteroidal medication (at least one month before entry). Low dose aspirin will not be considered as continuous nonsteroidal anti-inflammatory medication.
Known hypersensitivity to CY, aspirin or any nonsteroidal medication.
Current use of allopurinol, rifampin, methotrexate or warfarin.
Inflammatory conditions (such as SLE, autoimmune disease, etc.) which could respond to medications given in the medication protocol.
Medical conditions including: active or chronic infection requiring antimicrobial therapy, serious viral infection (hepatitis, herpes zoster), a single functioning kidney, renal insufficiency (less than one third of normal GFR), significant hepatic dysfunction, pre-existent malignancy, insulin-treated diabetes mellitus, severe benign prostatic hypertrophy, immunosuppression, myelosuppression, lymphopenia, severe pulmonary dysfunction, history of gastrointestinal ulceration active within the last 5 years, history of gastrointestinal bleeding or perforation, or severe cardiac dysfunction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
95 Years
Study:
NCT00013650
Study Brief:
Protocol Section:
NCT00013650