MedTrace Logo

A Pilot Trial of Interferon Beta-1a in Alzheimer's Disease

NCT01075763 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-02-13

Study results available
· View outcomes & findings →

Summary

This was a 52-week, multicentric, phase II, pilot study conducted in 40 subjects with early-onset Alzheimer's disease (AD) to evaluate safety, tolerability and clinical efficacy of subcutaneous (sc) interferon (IFN) beta-1a \[Rebif® 22 microgram (mcg), three times per week (tiw)\] in the treatment of AD by comparing the neuropsychological performance changes into placebo and treatment arms from screening/baseline to 52 week.

Conditions

Interventions

DRUG

Interferon beta-1a

Interferon (IFN) beta-1a \[Rebif® 22 microgram (mcg), three times per week (tiw)\] administered subcutaneously (sc)

DRUG

Placebo

The inactive substance (placebo) looks the same as Interferon beta-1a (Rebif®), and is given the same way

Sponsors & Collaborators

  • Merck Serono S.P.A., Italy

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Andrea Paolillo, MD, PhD · Merck Serono S.P.A., Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01075763 on ClinicalTrials.gov