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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.

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: MABT5102A Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 30, 2011
Actual Primary Completion Date : February 28, 2014
Actual Study Completion Date : February 28, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1: Subcutaneous cohort exp Drug: MABT5102A
Repeating subcutaneous injection

Experimental: Part 2: Intravenous cohort exp Drug: MABT5102A
Repeating intravenous infusion

Placebo Comparator: Part 1: Subcutaneous cohort
Repeating subcutaneous injection
Drug: placebo
Repeating subcutaneous injection

Placebo Comparator: Part 2: Intravenous cohort
Repeating intravenous infusion
Drug: placebo
Repeating intravenous infusion




Primary Outcome Measures :
  1. Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score [ Time Frame: From baseline to Week 73 ]
  2. Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score [ Time Frame: From baseline to Week 73 ]

Secondary Outcome Measures :
  1. Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score [ Time Frame: From baseline to Week 73 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343966


  Show 92 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Robert Paul, M.D., Ph.D. Genentech, Inc.

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01343966     History of Changes
Other Study ID Numbers: ABE4869g
ABBY ( Other Identifier: Genentech )
GN00761 ( Other Identifier: Hoffmann-La Roche )
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders