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Interferon beta-1a

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Merck KGaA|Last Updated: Feb 13, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

Interferon beta-1a · 1 trial · 1 indication

Phase 2 1
NCT01075763A Pilot Trial of Interferon Beta-1a in Alzheimer's DiseaseAlzheimer's Disease
COMPLETED42 Analytics
PHASE2COMPLETED
A Pilot Trial of Interferon Beta-1a in Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score
Baseline and Week 52

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).

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment arm - Rebif®EXPERIMENTALSubjets in this arm received interferon beta-1a (Rebif® 22 mcg tiw)
Placebo armPLACEBO_COMPARATORSubjects in this arm received placebo

Interventions

NameTypeDescription
Interferon beta-1aDRUGInterferon (IFN) beta-1a \[Rebif® 22 microgram (mcg), three times per week (tiw)\] administered subcutaneously (sc)
PlaceboDRUGThe inactive substance (placebo) looks the same as Interferon beta-1a (Rebif®), and is given the same way
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Eligibility Criteria

Age Range50 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 giv...

Countries:Italy
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Frequently asked questions about Interferon beta-1a

What is Interferon beta-1a used for in Alzheimer's Disease?

Interferon beta-1a is being investigated as a treatment for Alzheimer's Disease. It is currently in Phase 2 clinical development for this indication. The drug is being studied in a pilot trial to assess its effects in patients with Alzheimer's Disease.

Who makes Interferon beta-1a?

Interferon beta-1a is being developed by Merck KGaA, a company traded under the ticker MKGAF. The company is conducting clinical research to evaluate the drug's potential in treating Alzheimer's Disease.

What phase is Interferon beta-1a in for Alzheimer's Disease?

Interferon beta-1a is in Phase 2 clinical development for Alzheimer's Disease. It is an investigational drug and has not been approved for this use. One Phase 2 trial has been completed to evaluate its safety and efficacy.

What clinical trials is Interferon beta-1a in for Alzheimer's Disease?

Interferon beta-1a has been studied in a completed Phase 2 trial with the identifier NCT01075763. This trial, titled 'A Pilot Trial of Interferon Beta-1a in Alzheimer's Disease,' enrolled 42 participants in Italy and was placebo-controlled and double-blind.

Is Interferon beta-1a the same as other interferon beta products?

Interferon beta-1a is a specific form of interferon beta. It is being studied for Alzheimer's Disease, a different condition from the multiple sclerosis indications for which other interferon beta products are commonly known.