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

This study has been completed.
Sponsor:
Collaborator:
Merck Serono S.P.A., Italy
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01075763
First received: February 24, 2010
Last updated: March 7, 2012
Last verified: March 2012
History of Changes
Results First Received: March 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Interferon beta-1a
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Rebif 22 Mcg Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
Placebo Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).

Participant Flow:   Overall Study
    Rebif 22 Mcg     Placebo  
STARTED     23     19  
COMPLETED     19     15  
NOT COMPLETED     4     4  
Lost to Follow-up                 2                 1  
Lack of Efficacy                 0                 1  
Withdrawal by Subject                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Rebif 22 Mcg Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
Placebo Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
Total Total of all reporting groups

Baseline Measures
    Rebif 22 Mcg     Placebo     Total  
Number of Participants  
[units: participants]
 		  23     19     42  
Age  
[units: years]
Mean ± Standard Deviation 		  63.00  ± 9.08     64.58  ± 6.41     63.71  ± 7.87  
Gender  
[units: participants]
 		     
Female     15     11     26  
Male     8     8     16  



  Outcome Measures
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1.  Primary:   Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score   [ Time Frame: Baseline and Week 52 ]
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2.  Secondary:   Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score   [ Time Frame: Week 12 and 28 ]
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3.  Secondary:   Mini Mental Status Examination (MMSE) Score   [ Time Frame: Baseline, Week 12, 28 and 52 ]
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4.  Secondary:   Alzheimer's Disease Assessment Scale, Non-cognitive Subscale (ADAS-NonCog) Score   [ Time Frame: Baseline, Week 12, 28 and 52 ]
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5.  Secondary:   Instrumental Activities of Daily Living (IADL) Score   [ Time Frame: Baseline, Week 28 and 52 ]
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6.  Secondary:   Physical Self-Maintenance Scale (PSMS) Score   [ Time Frame: Baseline, Week 28 and 52 ]
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7.  Secondary:   Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score   [ Time Frame: Week 28 and 52 ]
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8.  Secondary:   Geriatric Depression Scale (GDS) Score   [ Time Frame: Baseline, Week 28 and 52 ]
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9.  Secondary:   Global Deterioration Scale Score   [ Time Frame: Baseline, Week 28 and 52 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merck.de


No publications provided


Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01075763     History of Changes
Other Study ID Numbers: 24386
Study First Received: February 24, 2010
Results First Received: March 7, 2012
Last Updated: March 7, 2012
Health Authority: Italy: The Italian Medicines Agency