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

NCT01075763 | Completed Phase 2 Results

• 1 other identifier: 24386
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Alzheimer's Disease

Keywords

Alzheimer's; Dementia; Interferon beta-1a; Rebif

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score

  ADAS: global rating scale created to evaluate both cognitive and functional aspects linked with disease progression. ADAS-Cog: subscale of ADAS which consists in a series of short tests aimed to evaluate possible cognitive impairment due to disease progression. It includes 11 items, testing word-finding difficulty, following commands, naming: objects and fingers, orientation, word recognition, recall of test instructions, constructions, ideational praxis, spoken language ability, comprehension of spoken language and word recall. Scores range from 0 (no impairment) to 70 (serious deficit).

  Baseline and Week 52

Secondary Outcomes (8)

• Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score

  Week 12 and 28

• Mini Mental Status Examination (MMSE) Score

  Baseline, Week 12, 28 and 52

• Alzheimer's Disease Assessment Scale, Non-cognitive Subscale (ADAS-NonCog) Score

  Baseline, Week 12, 28 and 52

• Instrumental Activities of Daily Living (IADL) Score

  Baseline, Week 28 and 52

• Physical Self-Maintenance Scale (PSMS) Score

  Baseline, Week 28 and 52

Study Arms (2)

Treatment arm - Rebif®

EXPERIMENTAL

Subjets in this arm received interferon beta-1a (Rebif® 22 mcg tiw)

Drug: Interferon beta-1a

Placebo arm

PLACEBO COMPARATOR

Subjects in this arm received placebo

Drug: Placebo

Interventions

Interferon beta-1a DRUG

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

Also known as: Rebif®

Treatment arm - Rebif®

Placebo DRUG

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

Placebo arm

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono S.P.A., Italy: collaborator

Study Sites (1)

U.VA. Neurologia - Azienda Ospedaliera Garibaldi Nesina

Catania, CT, 95122, Italy

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Andrea Paolillo, MD, PhD

  Merck Serono S.P.A., Italy

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: November 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: February 13, 2014
• Results First Posted: April 4, 2012

Record last verified: 2014-01

Locations

IT (1)