A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
- Registration Number
- NCT01343966
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 448
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Subcutaneous cohort exp MABT5102A - Part 2: Intravenous cohort placebo Repeating intravenous infusion Part 2: Intravenous cohort exp MABT5102A - Part 1: Subcutaneous cohort placebo Repeating subcutaneous injection
- Primary Outcome Measures
Name Time Method Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score From baseline to Week 73 Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score From baseline to Week 73
- Secondary Outcome Measures
Name Time Method Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score From baseline to Week 73
Trial Locations
- Locations (90)
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
Pharmacology Research Inst
🇺🇸Newport Beach, California, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Univ of CA San Diego; Neurosciences Comp.Alzheimer's
🇺🇸La Jolla, California, United States
University of California Davis Medical System
🇺🇸Sacramento, California, United States
USC School of Medicine
🇺🇸Los Angeles, California, United States
Neurological Research Inst
🇺🇸Santa Monica, California, United States
Meridien Research
🇺🇸Brooksville, Florida, United States
Florida Atlantic University; College of Medicine
🇺🇸Boca Raton, Florida, United States
Brain Matters Research, Inc.
🇺🇸Delray Beach, Florida, United States
Axiom Clinical Research of Florida
🇺🇸Tampa, Florida, United States
Compass Research
🇺🇸Orlando, Florida, United States
Rush Alzheimer's Disease Cntr.
🇺🇸Chicago, Illinois, United States
Collier Neurologic Specialists
🇺🇸Naples, Florida, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
Alexian Brothers Neurosci Inst
🇺🇸Elk Grove Village, Illinois, United States
Millennium Psychiatric Associates, LLC
🇺🇸Creve Coeur, Missouri, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Empire Neurology, PC
🇺🇸Latham, New York, United States
University of Rochester Medical Center; Monroe Community Hospital
🇺🇸Rochester, New York, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
Investigational Drug Service; Univ of Rochester Medical Ctr
🇺🇸Rochester, New York, United States
Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, France
Summit Research Network Inc.
🇺🇸Portland, Oregon, United States
Neurology & Neuroscience Ctr of Ohio
🇺🇸Toledo, Ohio, United States
Clinical Trials of America, Inc.
🇺🇸Eugene, Oregon, United States
Medical Uni of South Carolina
🇺🇸North Charleston, South Carolina, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Jbn Medical Diagnostic Services Inc.
🇨🇦Burlington, Ontario, Canada
Hotel Dieu Hospital
🇨🇦Kingston, Ontario, Canada
St. Joseph's HC-Parkwood Hosp
🇨🇦London, Ontario, Canada
Bruyere Continuing Care
🇨🇦Ottawa, Ontario, Canada
Toronto Memory Program (Neurology Research Inc.)
🇨🇦Toronto, Ontario, Canada
Kawartha Regional Memory Clinic
🇨🇦Peterborough, Ontario, Canada
McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
🇨🇦Verdun, Quebec, Canada
Chu Limoges
🇫🇷Limoges, France
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
🇫🇷Bron, France
Hopital Nord Laennec
🇫🇷Nantes, France
Hopital de Cimiez
🇫🇷Nice, France
CHU de Rouen Hopital; Service de Neurologie
🇫🇷Rouen, France
Hopital Hautepierre; Centre dInvestigation Clinique
🇫🇷Strasbourg, France
Hôpital Casselardit; Cons memoire
🇫🇷Toulouse, France
Studienambulanz emovis GmbH; St. Joseph Krankenhaus
🇩🇪Berlin, Germany
Universitätsklinikum Erlangen; Augenklinik
🇩🇪Erlangen, Germany
Bezirkskrankenhaus Günzburg
🇩🇪Günzburg, Germany
Univ Berlin; Klin fur Psychi & Psycho Charite
🇩🇪Berlin, Germany
Zentralinstitut fuer Seelische Gesundheit
🇩🇪Mannheim, Germany
Inst fur Stedien zur Psych Ges
🇩🇪Mannheim, Germany
Psych Klin der LMU Muenchen
🇩🇪Muenchen, Germany
Ludwig-Maximilians-Univ.
🇩🇪Munchen, Germany
Klinikum rechts der Isar der Technischen Universität München
🇩🇪Munchen, Germany
Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
🇩🇪Tubingen, Germany
Villa Sauer, Praxis für; Neurologie und Psychiatrie
🇩🇪Siegen, Germany
Policlinica Guipuzcoa
🇪🇸San Sebastian, Guipuzcoa, Spain
Hospital Perpetuo Socorro
🇪🇸Albacete, Spain
Clinica Ruber, 4 planta; Servicio de Neurologia
🇪🇸Madrid, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
The Rice Centre; Royal United Hospital
🇬🇧Bath, United Kingdom
West London Research Unit; Brentford Lodge
🇬🇧Brentford, United Kingdom
Royal Sussex County Hospital, CIRU Level 5
🇬🇧Brighton, United Kingdom
Glasgow Memory Clinic
🇬🇧Glasgow, United Kingdom
The National Hospital for Neurology & Neurosurgery; Dementia Research Center
🇬🇧London, GT LON, United Kingdom
Great Western Hosp.; Kingshill Research Ctr
🇬🇧Swindon, United Kingdom
Hope Research Institute
🇺🇸Phoenix, Arizona, United States
Pacific Research Network - PRN
🇺🇸San Diego, California, United States
Miami Jewish Health Systems; Clinical Research
🇺🇸Miami, Florida, United States
Uni of California San Francisco
🇺🇸San Francisco, California, United States
IU Healthy Partners Adult Neurology Clinic
🇺🇸Indianapolis, Indiana, United States
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
🇺🇸Houston, Texas, United States
Hospital Universitario Virgen de la Macarena;
🇪🇸Sevilla, Spain
Clinique Neuro Rive-Sud
🇨🇦Greenfield Park, Quebec, Canada
CHAUQ Hopital Enfant-Jesus
🇨🇦Quebec City, Quebec, Canada
Camden Mews Day Hospital; Camden and Islington
🇬🇧London, United Kingdom
Southampton General Hospital; Pharmacy
🇬🇧Southampton, United Kingdom
Moorgreen Hospital; Memory Assessment & Rsch Ctr
🇬🇧Southampton, United Kingdom
Hopital Broca
🇫🇷Paris, France
Providence Care Centre; Mental Health Site
🇨🇦Kingston, Ontario, Canada
Hospital de Cruces; Servicio de Neurologia
🇪🇸Barakaldo, Vizcaya, Spain
Albany Medical College
🇺🇸Albany, New York, United States
Yale University
🇺🇸New Haven, Connecticut, United States
The Med Arts Health Rsrch Grp
🇨🇦Penticton, British Columbia, Canada
University of British Columbia Hospital; Division of Neurology
🇨🇦Vancouver, British Columbia, Canada
Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique
🇨🇦Montreal, Quebec, Canada
Memory Enhancement Center of NJ, Inc.
🇺🇸Toms River, New Jersey, United States
Clinical Neuroscience Research Associates, Inc.
🇺🇸Bennington, Vermont, United States
NeuroCognitive Institute
🇺🇸Mount Arlington, New Jersey, United States
Hospital General de Catalunya
🇪🇸San Cugat del Valles, Barcelona, Spain
Louisiana Research Associates
🇺🇸New Orleans, Louisiana, United States
Saibal Nandy Professional Corporation
🇨🇦Medicine Hat, Alberta, Canada
Capitol District Health Authority
🇨🇦Halilfax, Nova Scotia, Canada