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A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01397578
First received: July 18, 2011
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the effects of MABT5102A on brain amyloid burden (as assessed by amyloid PET imaging) and other biomarkers in patients with mild to moderate Alzheimer's disease.


Condition Intervention Phase
Alzheimer's Disease
Drug: MABT5102A
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Change in brain amyloid load as assessed by amyloid PET imaging [ Time Frame: Baseline to Week 69 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease [ Time Frame: Baseline to Week 69 ] [ Designated as safety issue: No ]
  • Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging [ Time Frame: Baseline to Week 69 ] [ Designated as safety issue: No ]
  • Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score [ Time Frame: Baseline to Week 73 ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: August 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: MABT5102A
Repeating subcutaneous injection
Drug: placebo
Repeating subcutaneous injection
Experimental: B Drug: MABT5102A
Repeating intravenous infusion
Drug: placebo
Repeating intravenous infusion

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable AD according to the NINCDS-ADRDA criteria
  • MMSE score of 18-26 points at screening
  • 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)
  • For patients currently receiving treatment with approved AD treatments (AChE inhibitors or memantine): Treatment initiated and continued for at least the last 3 months prior to randomization, at a stable dose for at least the last 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 (e.g., stroke, clinically significant carotid or vertebral stenosis or plaque, aortic aneurysm, intracranial aneurysm, cerebral hemorrhage, arteriovenous malformation)
  • History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma (e.g., cerebral contusion)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397578

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85006
Sun City, Arizona, United States, 85351
Tucson, Arizona, United States, 85741
United States, California
Fresno, California, United States, 93720
Los Angeles, California, United States, 90095
Oxnard, California, United States, 93030
Santa Rosa, California, United States, 95403
Stanford, California, United States, 94305
United States, Florida
Fort Myers, Florida, United States, 33912
Ft Myers, Florida, United States, 33912
Hallandale Beach, Florida, United States, 33009
Orlando, Florida, United States, 32806
United States, Georgia
Decatur, Georgia, United States, 30033
United States, Illinois
Elk Grove Village, Illinois, United States, 60007
United States, Mississippi
Hattiesburg, Mississippi, United States, 39401
United States, Nevada
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Eatontown, New Jersey, United States, 07724
United States, New York
Manhasset, New York, United States, 11030
United States, Ohio
Toledo, Ohio, United States, 43623
United States, Pennsylvania
Jenkintown, Pennsylvania, United States, 19046
United States, Rhode Island
East Providence, Rhode Island, United States, 02914
Providence, Rhode Island, United States, 02906
France
Nancy, France, 54035
Toulouse, France, 31059
Tours Cedex 9, France, 37044
Spain
BArcelon, Barcelona, Spain, 08034
Barcelona, Spain, 08907
Barcelona, Spain, 08003
Barcelona, Spain, 08221
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Robert Paul, M.D., Ph.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01397578     History of Changes
Other Study ID Numbers: ABE4955g, GN00762
Study First Received: July 18, 2011
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 23, 2014