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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono S.P.A., Italy
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• Subjects aged between 50 and 75 years

• Subjects diagnosed with AD, according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)

• Subjects with MMSE score of 20 to 26 (inclusive)

• Subjects supervised by a caregiver

• Subjects who have been given informed written consent and approval of the Local Ethical Committee

Exclusion Criteria:

• Subjects with constant use in the 3 months prior study enrolment of other drugs that can modify the course of the disease (e.g. statins, nonsteroidal anti-inflammatory drugs [NSAIDs] and steroids) or symptomatic cognitive treatments (e.g. cholinesterase inhibitors)

• Subjects with modified Hachinski Ischemic Score ≥ 4

• Subjects who are unable to undergo neuropsychological evaluation (including analphabetism)

• Subjects with significant liver (aspartate aminotransferase, alanine aminotransferase , alkaline phosphatase > 2.0 times the upper limit of normal [ULN] of the local laboratory, or total bilirubin > 1.5 times the ULN of the local laboratory), thyroid (according to clinical judgment) or hematological dysfunctions (e.g. leucocytes ≤ 2.0
• 109/Liter [L]; platelets ≤ 100 * 109/L; hemoglobin ≤ 12 gram/deciliter [g/dL] for women and ≤ 13 g/dL for men, serum albumin ≤ 3 g/dL)

• Subjects with history (past or recurrent) of depression unresponsive to medication or past medical history of suicidal ideation

• Subjects with severe cardiac disease (angina, congestive heart failure class 3-4 New York Heart Association [NYHA] Functional Classification , or severe arrhythmia)

• Subjects with epilepsy

• Subjects with concomitant use of hypnotic, anxiolytic, antidepressant, antipsychotic, anticholinergic

• Subjects with known allergic reactions against IFNs or other components of the applied drug