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Effects of an Anti-Inflammatory Drug in Alzheimer's Disease
Pilot Study of Immunomodulatory Versus Antiinflammatory Therapy in Alzheimer's Disease
Lead sponsor
Asset
Cyclophosphamide
Listed sites
1
Recruiting sites
-
Enrollment
60
Study population
Alzheimer’s disease
Key I/E criterion
•Alzheimer's disease
Primary endpoint
-
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (0)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
No endpoints recorded for this trial.
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID10680787via BACKGROUND
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.