A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease
- Registration Number
- NCT01397578
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Subcutaneous cohort exp MABT5102A - Part 2: Intravenous cohort exp MABT5102A - Part 1: Subcutaneous cohort placebo Repeating subcutaneous injection Part 2: Intravenous cohort placebo Repeating intravenous injection
- Primary Outcome Measures
Name Time Method Change in brain amyloid load as assessed by amyloid PET imaging Baseline to Week 69
- Secondary Outcome Measures
Name Time Method Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease Baseline to Week 69 Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging Baseline to Week 69 Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score Baseline to Week 73
Trial Locations
- Locations (29)
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
Scroll for more (19 remaining)Banner Alzheimer's Institute🇺🇸Phoenix, Arizona, United States