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CompletedPhase 1

Effects of an Anti-Inflammatory Drug in Alzheimer's Disease

Pilot Study of Immunomodulatory Versus Antiinflammatory Therapy in Alzheimer's Disease

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

Secondary01-M-0128
Org study ID010128
NCT IDNCT00013650

Timeline

Milestones

Study start2001-03-22
Study first posted2001-03-28estimated
Study completion2008-04-21
Last update posted2017-07-02actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age95 Years
SexAll
Healthy volunteersNot accepted

Inclusion 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.

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.