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A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

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ClinicalTrials.gov Identifier: NCT01343966
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE April 27, 2011
First Posted Date  ICMJE April 28, 2011
Last Update Posted Date July 12, 2017
Actual Study Start Date  ICMJE April 30, 2011
Actual Primary Completion Date February 28, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
  • Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score [ Time Frame: From baseline to Week 73 ]
  • Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score [ Time Frame: From baseline to Week 73 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
  • Change in ADAS-Cog score [ Time Frame: From baseline to Week 73 ]
  • Change in CDR-SOB score [ Time Frame: From baseline to Week 73 ]
Change History Complete list of historical versions of study NCT01343966 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score [ Time Frame: From baseline to Week 73 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
Change in ADCS-ADL score [ Time Frame: From baseline to Week 73 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
Official Title  ICMJE A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
Brief Summary This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's Disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: MABT5102A
    Repeating subcutaneous injection
  • Drug: MABT5102A
    Repeating intravenous infusion
  • Drug: placebo
    Repeating subcutaneous injection
  • Drug: placebo
    Repeating intravenous infusion
Study Arms  ICMJE
  • Experimental: Part 1: Subcutaneous cohort exp
    Intervention: Drug: MABT5102A
  • Experimental: Part 2: Intravenous cohort exp
    Intervention: Drug: MABT5102A
  • Placebo Comparator: Part 1: Subcutaneous cohort
    Repeating subcutaneous injection
    Intervention: Drug: placebo
  • Placebo Comparator: Part 2: Intravenous cohort
    Repeating intravenous infusion
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2014)
448
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2011)
372
Actual Study Completion Date  ICMJE February 28, 2014
Actual Primary Completion Date February 28, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria
  • Mini-Mental State Examination (MMSE) score of 18-26 points at screening
  • Geriatric Depression Scale (GDS-15) score of < 6
  • Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders)
  • If receiving concurrent AD treatment, patient must be on the medication for at least 3 months at a stable dose for at least 2 months prior to randomization.

Exclusion Criteria:

  • Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care
  • History or presence of clinically evident vascular disease potentially affecting the brain
  • History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma
  • Hospitalization within 4 weeks prior to screening
  • Previous treatment with MABT5102A or any other therapeutic that targets Abeta
  • Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01343966
Other Study ID Numbers  ICMJE ABE4869g
ABBY ( Other Identifier: Genentech )
GN00761 ( Other Identifier: Hoffmann-La Roche )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Paul, M.D., Ph.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP