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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:
ClinicalTrials.gov Identifier:
NCT01397578
First Posted: July 19, 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.
  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 (Participant, 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 ]

Secondary Outcome Measures:
  • Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease [ Time Frame: Baseline to Week 69 ]
  • Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging [ Time Frame: Baseline to Week 69 ]
  • Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score [ Time Frame: Baseline to Week 73 ]

Enrollment: 91
Actual Study Start Date: August 31, 2011
Study Completion Date: April 30, 2014
Primary Completion Date: April 30, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 injection
Drug: placebo
Repeating intravenous infusion

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
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)
  • 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
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): NCT01397578


  Hide Study Locations
Locations
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85020
Banner Sun Health Research Insitute
Sun City, Arizona, United States, 85351
NNS Clinical Research LLC
Tucson, Arizona, United States, 85704
United States, California
Margolin Brain Institute
Fresno, California, United States, 93720
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Pacific Neuroscience Med Grp
Oxnard, California, United States, 93030
Stanford Univ Medical Center
Palo Alto, California, United States, 94304
Redwood Regional Medical Group
Santa Rosa, California, United States, 95403
United States, Florida
Internal Med Assoc of Lee Cty
Fort Myers, Florida, United States, 33912
Neuropsychiatric Research; Center of Southwest Florida
Fort Myers, Florida, United States, 33912
MD Clinical
Hallandale Beach, Florida, United States, 33009
Compass Research
Orlando, Florida, United States, 32806
United States, Georgia
Dekalb Neurology Associates
Decatur, Georgia, United States, 30033
United States, Illinois
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, United States, 60007
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Nevada
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
United States, New York
Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.
Manhasset, New York, United States, 11030
United States, Ohio
Neurology & Neuroscience Ctr of Ohio
Toledo, Ohio, United States, 43623
United States, Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
United States, Rhode Island
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States, 02914
Butler Hospital
Providence, Rhode Island, United States, 02906
France
Hopital Central-CHU de Nancy; Pharmacie
Nancy, France, 54035
Hôpital Casselardit; Cons memoire
Toulouse, France, 31059
Clinique Psychiatrique Univ
Tours Cedex 9, France, 37044
Spain
Fundació ACE
BArcelon, Barcelona, Spain, 08034
Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital del Mar
Barcelona, Spain, 08003
Hospital Mutua De Terrasa
Barcelona, Spain, 08221
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Robert Paul, M.D., Ph.D. Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01397578     History of Changes
Other Study ID Numbers: ABE4955g
GN00762 ( Other Identifier: Hoffmann-La Roche )
First Submitted: July 18, 2011
First Posted: July 19, 2011
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