Prevention of Cognitive Decline in Alzheimer's Disease by Ingested Interferon Alpha

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: Pfizer
• Treatments: Donepezil; Interferon alpha-2; Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.