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

Genentech, Inc.29 sites in 3 countries91 target enrollmentAugust 31, 2011

ConditionsAlzheimer's Disease

InterventionsMABT5102A placebo

DrugsMABT5102A placebo

Overview

Phase: Phase 2
Intervention: MABT5102A
Conditions: Alzheimer's Disease
Sponsor: Genentech, Inc.
Enrollment: 91
Locations: 29
Primary Endpoint: Change in brain amyloid load as assessed by amyloid PET imaging
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 31, 2011

End Date

April 30, 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Part 1: Subcutaneous cohort exp

Intervention: MABT5102A

Part 2: Intravenous cohort exp

Intervention: MABT5102A

Part 1: Subcutaneous cohort

Repeating subcutaneous injection

Intervention: placebo

Part 2: Intravenous cohort

Repeating intravenous injection

Intervention: placebo

Outcomes

Primary Outcomes

Change in brain amyloid load as assessed by amyloid PET imaging

Time Frame: Baseline to Week 69

Secondary Outcomes

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