Prevention of Cognitive Decline in Alzheimer's Disease by Ingested Interferon Alpha
1 other identifier
interventional
N/A
1 country
1
Brief Summary
In this phase I-II parallel design, randomized, double-blind clinical trial we will determine if 3,000 or 30,000 units ingested hrIFN-a prevents deterioration of cognitive functioning in patients with dementia of Alzheimer's type (AD) and whether ingested hrIFN-a treatment decreases acute phase reactants and pro-inflammatory cytokine IL-6 in mild to moderate AD. We predict that the novel anti-inflammatory agent ingested human recombinant interferon alpha (hrIFN-a) will modulate inflammation and inhibit the natural history of AD progression. If you are eligible, you will receive Aricept for 5 weeks (donezepil) and thereafter in addition to Aricept either placebo (inactive substance) or interferon alpha at 3,000 or 30,000 units every day for 12 months.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2002
CompletedFirst Posted
Study publicly available on registry
February 22, 2002
CompletedFebruary 5, 2008
February 1, 2008
February 20, 2002
February 4, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Males and females, age 50 or greater. Possible or probable dementia of the Alzheimer Type defined by NINDS-ARDA criteria with dementia of at least one year duration.
- Folstein MMSE Score 10-24 inclusive. Vision, hearing, speech, motor function and comprehension must be adequate for compliance with all testing procedures.
You may not qualify if:
- Absence of a reliable caregiver. Clinical or radiological evidence for other neurological disorders such as Parkinson's disease, normal pressure hydrocephalus, multi-infarct dementia, idiopathic seizure disorder, CNS infectious disease.
- History of major psychiatric disorders; schizophrenia and unipolar or bipolar depression.
- Presence of any significant medical disorder which might cause or contribute to dementia such as B12 or folic acid deficiency, untreated hypothyroidism, history of significant alcohol abuse (within the past 10 years).
- Patients with recent (\< 2 years) hematologic/oncologic disorders (other than basal or squamous cell carcinoma of the skin.
- Patients with recent (\< 3 months) myocardial infarction, poorly controlled CHF, surgery for peripheral vascular disease, or coronary artery bypass surgery.
- Evidence of clinically significant or unstable active GI, hepatic or pulmonary disease.
- History of documented stroke or more than one confirmed TIA. Any condition which would make the patient or caregiver, in the opinion of the principal investigator unsuitable for the study.
- Patients with known hypersensitivity to Donezepil HCL or other piperidine containing drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Center for Research Resources (NCRR)lead
- Pfizercollaborator
Study Sites (1)
University of Texas - Houston, Gerontology Center of the UTMSI
Houston, Texas, 77030, United States
Related Publications (1)
Brod SA. Unregulated inflammation shortens human functional longevity. Inflamm Res. 2000 Nov;49(11):561-70. doi: 10.1007/s000110050632.
PMID: 11131295BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 20, 2002
First Posted
February 22, 2002
Last Updated
February 5, 2008
Record last verified: 2008-02