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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01397578

Run by

Genentech, Inc.

People needed

91

Starts

2011-08-31

Expected to finish

2014-04-30

Last updated by the study team

2017-07-12

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• Banner Sun Health Research Insitute — Sun City, Arizona, United States
• NNS Clinical Research LLC — Tucson, Arizona, United States
• Margolin Brain Institute — Fresno, California, United States
• University of California Los Angeles (UCLA) — Los Angeles, California, United States
• Pacific Neuroscience Med Grp — Oxnard, California, United States
• Stanford Univ Medical Center — Palo Alto, California, United States
• Redwood Regional Medical Group — Santa Rosa, California, United States
• Internal Med Assoc of Lee Cty — Fort Myers, Florida, United States
• Neuropsychiatric Research; Center of Southwest Florida — Fort Myers, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• Compass Research — Orlando, Florida, United States
• Dekalb Neurology Associates — Decatur, Georgia, United States
• Alexian Brothers Neurosci Inst — Elk Grove Village, Illinois, United States
• Hattiesburg Clinic — Hattiesburg, Mississippi, United States
• Cleveland Clinic Lou Ruvo; Center for Brain Research — Las Vegas, Nevada, United States
• Memory Enhancement Center of America, Inc. — Eatontown, New Jersey, United States
• Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch. — Manhasset, New York, United States
• Neurology & Neuroscience Ctr of Ohio — Toledo, Ohio, United States
• The Clinical Trial Center, LLC — Jenkintown, Pennsylvania, United States
• Rhode Island Mood & Memory Research Institute — East Providence, Rhode Island, United States
• Butler Hospital — Providence, Rhode Island, United States
• Hopital Central-CHU de Nancy; Pharmacie — Nancy, France
• Hôpital Casselardit; Cons memoire — Toulouse, France
• Clinique Psychiatrique Univ — Tours, France

Full record on ClinicalTrials.gov

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