Phase 2
Completed N=42
A Pilot Trial of Interferon Beta-1a in Alzheimer's Disease
Source: ClinicalTrials.gov NCT01075763 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcomePrimary: Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score — 18.63; 19.81; 20.66; 20.33 units on a scale — p=0.64
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score |
16.74; 17.97; 18.49; 17.55 | 0.63 |
| SECONDARY Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score |
16.74; 17.97; 18.49; 17.55 | 0.63 |
| SECONDARY Mini Mental Status Examination (MMSE) Score |
23.46; 22.93; 24.50; 24.66; 24.25; 23.66 | 0.45 |
| SECONDARY Alzheimer's Disease Assessment Scale, Non-cognitive Subscale (ADAS-NonCog) Score |
4.37; 6.07; 3.53; 4.73; 4.63; 5.20 | 0.29 |
| SECONDARY Instrumental Activities of Daily Living (IADL) Score |
6.11; 6.20; 5.84; 5.60; 4.89; 5.67 | 0.86 |
| SECONDARY Physical Self-Maintenance Scale (PSMS) Score |
6.42; 6.40; 6.74; 7.00; 7.79; 6.87 | 0.95 |
| SECONDARY Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score |
1; 0; 0; 2; 7; 6 | — |
| SECONDARY Geriatric Depression Scale (GDS) Score |
10.11; 10.67; 9.68; 9.07; 10.79; 7.50 | 0.80 |
| SECONDARY Global Deterioration Scale Score |
3.00; 2.87; 3.05; 3.00; 3.26; 3.20 | 0.53 |
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
Data sourced from ClinicalTrials.gov (NCT01075763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.