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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01343966
First Posted: April 28, 2011
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
April 27, 2011
April 28, 2011
July 12, 2017
April 30, 2011
February 28, 2014   (Final data collection date for primary outcome measure)
  • 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 ]
  • Change in ADAS-Cog score [ Time Frame: From baseline to Week 73 ]
  • Change in CDR-SOB score [ Time Frame: From baseline to Week 73 ]
Complete list of historical versions of study NCT01343966 on ClinicalTrials.gov Archive Site
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score [ Time Frame: From baseline to Week 73 ]
Change in ADCS-ADL score [ Time Frame: From baseline to Week 73 ]
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
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)
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: MABT5102A
    Repeating subcutaneous injection
  • Drug: MABT5102A
    Repeating intravenous infusion
  • Drug: placebo
    Repeating subcutaneous injection
  • Drug: placebo
    Repeating intravenous infusion
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
448
February 28, 2014
February 28, 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Germany,   Spain,   United Kingdom,   United States
 
 
NCT01343966
ABE4869g
ABBY ( Other Identifier: Genentech )
GN00761 ( Other Identifier: Hoffmann-La Roche )
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Robert Paul, M.D., Ph.D. Genentech, Inc.
Genentech, Inc.
July 2017

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