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

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: MABT5102A; Drug: placebo

• 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

Study Timeline

• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Study Start: 2011-08-31
• Primary Completion: 2014-04-30
• Study Completion: 2014-04-30
• Disposition First Submitted: 2016-08-10
• Disposition First Submitted QC: 2016-08-10
• Disposition First Posted: 2016-08-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-10
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

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)

Hospital Mutua De Terrasa; 🇪🇸 Barcelona, Spain

NNS Clinical Research LLC; 🇺🇸 Tucson, Arizona, United States

Pacific Neuroscience Med Grp; 🇺🇸 Oxnard, California, United States

Hopital Central-CHU de Nancy; Pharmacie; 🇫🇷 Nancy, France

Margolin Brain Institute; 🇺🇸 Fresno, California, United States

University of California Los Angeles (UCLA); 🇺🇸 Los Angeles, California, United States

Internal Med Assoc of Lee Cty; 🇺🇸 Fort Myers, Florida, United States

Hattiesburg Clinic; 🇺🇸 Hattiesburg, Mississippi, United States

Cleveland Clinic Lou Ruvo; Center for Brain Research; 🇺🇸 Las Vegas, Nevada, United States

Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.; 🇺🇸 Manhasset, New York, United States

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

Redwood Regional Medical Group; 🇺🇸 Santa Rosa, California, United States

Neuropsychiatric Research; Center of Southwest Florida; 🇺🇸 Fort Myers, Florida, United States

Compass Research; 🇺🇸 Orlando, Florida, United States

MD Clinical; 🇺🇸 Hallandale Beach, Florida, United States

Stanford Univ Medical Center; 🇺🇸 Palo Alto, California, United States

Alexian Brothers Neurosci Inst; 🇺🇸 Elk Grove Village, Illinois, United States

Dekalb Neurology Associates; 🇺🇸 Decatur, Georgia, United States

Neurology & Neuroscience Ctr of Ohio; 🇺🇸 Toledo, Ohio, United States

Memory Enhancement Center of America, Inc.; 🇺🇸 Eatontown, New Jersey, United States

The Clinical Trial Center, LLC; 🇺🇸 Jenkintown, Pennsylvania, United States

Hôpital Casselardit; Cons memoire; 🇫🇷 Toulouse, France

Clinique Psychiatrique Univ; 🇫🇷 Tours Cedex 9, France

Fundació ACE; 🇪🇸 BArcelon, Barcelona, Spain

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States

Rhode Island Mood & Memory Research Institute; 🇺🇸 East Providence, Rhode Island, United States

Hospital Universitario de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Banner Sun Health Research Insitute; 🇺🇸 Sun City, Arizona, United States