A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

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 safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's Disease.

Key facts

Study ID

NCT01343966

Run by

Genentech, Inc.

People needed

448

Starts

2011-04-30

Expected to finish

2014-02-28

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)
• 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.

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
• 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

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Pharmacology Research Inst — Encino, California, United States
• Margolin Brain Institute — Fresno, California, United States
• Univ of CA San Diego; Neurosciences Comp.Alzheimer's — La Jolla, California, United States
• USC School of Medicine — Los Angeles, California, United States
• Pharmacology Research Inst — Newport Beach, California, United States
• University of California Davis Medical System — Sacramento, California, United States
• Pacific Research Network - PRN — San Diego, California, United States
• Uni of California San Francisco — San Francisco, California, United States
• Neurological Research Inst — Santa Monica, California, United States
• Yale University — New Haven, Connecticut, United States
• Florida Atlantic University; College of Medicine — Boca Raton, Florida, United States
• Meridien Research — Brooksville, Florida, United States
• Brain Matters Research, Inc. — Delray Beach, Florida, United States
• Miami Jewish Health Systems; Clinical Research — Miami, Florida, United States
• Collier Neurologic Specialists — Naples, Florida, United States
• Compass Research — Orlando, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Rush Alzheimer's Disease Cntr. — Chicago, Illinois, United States
• Alexian Brothers Neurosci Inst — Elk Grove Village, Illinois, United States
• IU Healthy Partners Adult Neurology Clinic — Indianapolis, Indiana, United States
• Louisiana Research Associates — New Orleans, Louisiana, United States
• Millennium Psychiatric Associates, LLC — Creve Coeur, Missouri, United States
• Hope Research Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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