Interferon Alpha for Alzheimer's Disease

Phase 2

Waitlist Available

Research Sponsored by National Center for Research Resources (NCRR)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females, age 50 or greater with possible or probable dementia of the Alzheimer Type defined by NINDS-ARDA criteria with dementia of at least one year duration

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing whether a new anti-inflammatory agent, hrIFN-a, can modulate inflammation and inhibit the progression of Alzheimer's disease. Eligible patients will receive Aricept for 5 weeks, then either placebo or interferon alpha at 3,000 or 30,000 units every day for 12 months.

Who is the study for?

This trial is for men and women over 50 with mild to moderate Alzheimer's Disease, having had symptoms for at least a year. Participants must have certain cognitive function levels (Folstein MMSE Score 10-24) and be able to perform tests. They can't join if they have other medical conditions that could affect dementia, recent serious heart issues or surgeries, other neurological disorders, major psychiatric disorders, or known allergies to Donezepil HCL.Check my eligibility

What is being tested?

The study is testing whether ingested human recombinant interferon alpha (hrIFN-a) can prevent worsening of cognitive functions in Alzheimer's patients. It will also look at its effects on inflammation markers. Patients will first receive Aricept for five weeks then either a placebo or hrIFN-a at two different doses daily for one year.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system modulation such as flu-like symptoms, changes in blood counts leading to increased infection risk or anemia, fatigue, and possible allergic reactions in those sensitive to the medication components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 50 or older and have been diagnosed with Alzheimer's for at least a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center for Research Resources (NCRR)Lead Sponsor

537 Previous Clinical Trials

317,016 Total Patients Enrolled

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,873 Total Patients Enrolled

Media Library

Aricept (Cholinesterase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00031018 — Phase 2

Alzheimer's Disease Research Study Groups:

Alzheimer's Disease Clinical Trial 2023: Aricept Highlights & Side Effects. Trial Name: NCT00031018 — Phase 2

Aricept (Cholinesterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00031018 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some possible side effects of this medication?

"While there is some safety data from Phase 2 trials, this treatment did not demonstrate efficacy in prior clinical trials and received a score of 2."

Answered by AI