A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

Genentech, Inc.90 sites in 2 countries448 target enrollmentApril 30, 2011

ConditionsAlzheimer's Disease

InterventionsMABT5102A placebo

DrugsMABT5102A placebo

Overview

Phase: Phase 2
Intervention: MABT5102A
Conditions: Alzheimer's Disease
Sponsor: Genentech, Inc.
Enrollment: 448
Locations: 90
Primary Endpoint: Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score
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 safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's Disease.

Registry

clinicaltrials.gov

Start Date

April 30, 2011

End Date

February 28, 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)
•If receiving concurrent AD treatment, patient must be on the medication for at least 3 months at a stable dose for at least 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
•History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma
•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