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REAL

CompletedPhase 2Results posted

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

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

Asset

Interferon beta-1a

Listed sites

1

Recruiting sites

-

Enrollment

42

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 20-26

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID24386
NCT IDNCT01075763

Timeline

Milestones

Study start2004-11 (month precision)
Primary completion2008-05actual (month precision)
Study completion2008-05actual (month precision)
Study first posted2010-02-25estimated
Results first posted2012-04-04estimated
Last update posted2014-02-13estimated

Assets

Drug assets

Interferon beta-1a

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
8
Behavior / neuropsychiatric
8
Function / daily living
2

Global cognition

8 endpoints
Primary/protocol endpoint

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

Time frame:Baseline and Week 52

ADAS-Cog

descriptive

Primary/registry result

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

Time frame:Baseline and Week 52

ADAS-Cog

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
Rebif 22 McgBaselinen=19 Participants18.637.86
Week 52n=19 Participants20.669.55
PlaceboBaselinen=15 Participants19.816.15
Week 52n=15 Participants20.3310.05
p0.64t-test, 2 sided

For baseline: the difference between the two groups was analyzed using t-test.

p0.92t-test, 2 sided

For Week 52: the difference between the two groups was analyzed using t-test.

Secondary/protocol endpoint

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

Time frame:Week 12 and 28

ADAS-Cog

descriptive

Secondary/protocol endpoint

Mini Mental Status Examination (MMSE) Score

Time frame:Baseline, Week 12, 28 and 52

Mini-Mental State Examination (MMSE)

concentration, descriptive

Secondary/protocol endpoint

Global Deterioration Scale Score

Time frame:Baseline, Week 28 and 52

ratio, descriptive

Secondary/registry result

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

Time frame:Week 12 and 28

ADAS-Cog

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
Rebif 22 McgWeek 12n=19 Participants16.746.94
Week 28n=19 Participants18.498.72
PlaceboWeek 12n=15 Participants17.976.28
Week 28n=15 Participants17.557.02
p0.63t-test, 2 sided

For Week 12: the difference between the two groups was analyzed using t-test.

p0.74t-test, 2 sided

For Week 28: the difference between the two groups was analyzed using t-test.

Secondary/registry result

Mini Mental Status Examination (MMSE) Score

Time frame:Baseline, Week 12, 28 and 52

Mini-Mental State Examination (MMSE)

concentration, descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
Rebif 22 McgBaselinen=19 Participants23.462.14
Week 12n=19 Participants24.503.22
Week 28n=19 Participants24.253.37
Week 52n=19 Participants22.435.33
PlaceboBaselinen=15 Participants22.931.79
Week 12n=15 Participants24.663.14
Week 28n=15 Participants23.664.92
Week 52n=15 Participants21.985.32
p0.45t-test, 2 sided

For baseline: the difference between the two groups was analyzed using t-test.

p0.88t-test, 2 sided

For Week 12: the difference between the two groups was analyzed using t-test.

p0.68t-test, 2 sided

For Week 28: the difference between the two groups was analyzed using t-test.

p0.81t-test, 2 sided

For Week 52: the difference between the two groups was analyzed using t-test.

Secondary/registry result

Global Deterioration Scale Score

Time frame:Baseline, Week 28 and 52

ratio, descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
Rebif 22 McgBaselinen=19 Participants3.000.47
Week 28n=19 Participants3.050.78
Week 52n=19 Participants3.260.81
PlaceboBaselinen=15 Participants2.870.74
Week 28n=15 Participants3.000.93
Week 52n=15 Participants3.201.08
p0.53t-test, 2 sided

For baseline: the difference between the two groups was analyzed using t-test.

p0.85t-test, 2 sided

For Week 28: the difference between the two groups was analyzed using t-test.

p0.85t-test, 2 sided

For Week 52: the difference between the two groups was analyzed using t-test.

Function / daily living

2 endpoints
Secondary/protocol endpoint

Instrumental Activities of Daily Living (IADL) Score

Time frame:Baseline, Week 28 and 52

ratio, descriptive

Secondary/registry result

Instrumental Activities of Daily Living (IADL) Score

Time frame:Baseline, Week 28 and 52

ratio, descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
Rebif 22 McgBaselinen=19 Participants6.111.45
Week 28n=19 Participants5.841.17
Week 52n=19 Participants4.891.85
PlaceboBaselinen=15 Participants6.201.57
Week 28n=15 Participants5.601.68
Week 52n=15 Participants5.671.63
p0.86t-test, 2 sided

For baseline: the difference between the two groups was analyzed using t-test.

p0.62t-test, 2 sided

For Week 28: the difference between the two groups was analyzed using t-test.

p0.21t-test, 2 sided

For Week 52: the difference between the two groups was analyzed using t-test.

Behavior / neuropsychiatric

8 endpoints
Secondary/protocol endpoint

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

Time frame:Baseline, Week 12, 28 and 52

concentration, descriptive

Secondary/protocol endpoint

Physical Self-Maintenance Scale (PSMS) Score

Time frame:Baseline, Week 28 and 52

categorical status, descriptive

Secondary/protocol endpoint

Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score

Time frame:Week 28 and 52

descriptive

Secondary/protocol endpoint

Geriatric Depression Scale (GDS) Score

Time frame:Baseline, Week 28 and 52

descriptive

Secondary/registry result

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

Time frame:Baseline, Week 12, 28 and 52

concentration, descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
Rebif 22 McgBaselinen=19 Participants4.374.13
Week 12n=19 Participants3.533.24
Week 28n=19 Participants4.634.36
Week 52n=19 Participants5.475.17
PlaceboBaselinen=15 Participants6.075.01
Week 12n=15 Participants4.734.27
Week 28n=15 Participants5.203.43
Week 52n=15 Participants7.206.97
p0.29t-test, 2 sided

For baseline: the difference between the two groups was analyzed using t-test.

p0.36t-test, 2 sided

For Week 12: the difference between the two groups was analyzed using t-test.

p0.68t-test, 2 sided

For Week 28: the difference between the two groups was analyzed using t-test.

p0.41t-test, 2 sided

For Week 52: the difference between the two groups was analyzed using t-test.

Secondary/registry result

Physical Self-Maintenance Scale (PSMS) Score

Time frame:Baseline, Week 28 and 52

categorical status, descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
Rebif 22 McgBaselinen=19 Participants6.421.02
Week 28n=19 Participants6.741.37
Week 52n=19 Participants7.793.34
PlaceboBaselinen=15 Participants6.400.91
Week 28n=15 Participants7.002.65
Week 52n=15 Participants6.871.68
p0.95t-test, 2 sided

For baseline: the difference between the two groups was analyzed using t-test.

p0.73t-test, 2 sided

For Week 28: the difference between the two groups was analyzed using t-test.

p0.30t-test, 2 sided

For Week 52: the difference between the two groups was analyzed using t-test.

Secondary/registry result

Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score

Time frame:Week 28 and 52

descriptive

Posted result

GroupValue (number), participantsReported bounds
Rebif 22 McgWeek 28: CIBIC-PLUS Score 1n=19 Participants1-
Week 28: CIBIC-PLUS Score 2n=19 Participants0-
Week 28: CIBIC-PLUS Score 3n=19 Participants7-
Week 28: CIBIC-PLUS Score 4n=19 Participants8-
Week 28: CIBIC-PLUS Score 5n=19 Participants3-
Week 28: CIBIC-PLUS Score 6n=19 Participants0-
Week 28: CIBIC-PLUS Score 7n=19 Participants0-
Week 52: CIBIC-PLUS Score 1n=19 Participants0-
Week 52: CIBIC-PLUS Score 2n=19 Participants0-
Week 52: CIBIC-PLUS Score 3n=19 Participants6-
Week 52: CIBIC-PLUS Score 4n=19 Participants7-
Week 52: CIBIC-PLUS Score 5n=19 Participants1-
Week 52: CIBIC-PLUS Score 6n=19 Participants4-
Week 52: CIBIC-PLUS Score 7n=19 Participants1-
PlaceboWeek 28: CIBIC-PLUS Score 1n=15 Participants0-
Week 28: CIBIC-PLUS Score 2n=15 Participants2-
Week 28: CIBIC-PLUS Score 3n=15 Participants6-
Week 28: CIBIC-PLUS Score 4n=15 Participants5-
Week 28: CIBIC-PLUS Score 5n=15 Participants0-
Week 28: CIBIC-PLUS Score 6n=15 Participants2-
Week 28: CIBIC-PLUS Score 7n=15 Participants0-
Week 52: CIBIC-PLUS Score 1n=15 Participants0-
Week 52: CIBIC-PLUS Score 2n=15 Participants2-
Week 52: CIBIC-PLUS Score 3n=15 Participants2-
Week 52: CIBIC-PLUS Score 4n=15 Participants4-
Week 52: CIBIC-PLUS Score 5n=15 Participants4-
Week 52: CIBIC-PLUS Score 6n=15 Participants3-
Week 52: CIBIC-PLUS Score 7n=15 Participants0-
Secondary/registry result

Geriatric Depression Scale (GDS) Score

Time frame:Baseline, Week 28 and 52

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
Rebif 22 McgBaselinen=19 Participants10.116.13
Week 28n=19 Participants9.685.74
Week 52n=19 Participants10.795.93
PlaceboBaselinen=15 Participants10.676.53
Week 28n=15 Participants9.074.32
Week 52n=15 Participants7.505.56
p0.80t-test, 2 sided

For baseline: the difference between the two groups was analyzed using t-test.

p0.74t-test, 2 sided

For Week 28: the difference between the two groups was analyzed using t-test.

p0.12t-test, 2 sided

For Week 52: the difference between the two groups was analyzed using t-test.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.