drugset / Trial / NCT00031018

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

NCT00031018

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Interferon Protein / enzyme biologic 3000 iu Oral
Subject Interferon Protein / enzyme biologic 30000 iu Oral
Background Donepezil Small molecule

Indications