A Pilot Trial of Interferon Beta-1a in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Interferon beta-1a; Placebo
Intervention description: Interferon (IFN) beta-1a [Rebif® 22 microgram (mcg), three times per week (tiw)] administered subcutaneously (sc); The inactive substance (placebo) looks the same as Interferon beta-1a (Rebif®), and is given the same way
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Alzheimer's; Dementia; Interferon beta-1a; Rebif

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.
    

Eligibility 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