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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01343966
First received: April 27, 2011
Last updated: July 10, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Alzheimer's Disease Drug: MABT5102A Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score [ Time Frame: From baseline to Week 73 ]
  • Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score [ Time Frame: From baseline to Week 73 ]

Secondary Outcome Measures:
  • Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score [ Time Frame: From baseline to Week 73 ]

Enrollment: 448
Actual Study Start Date: April 30, 2011
Study Completion Date: February 28, 2014
Primary Completion Date: February 28, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: Subcutaneous cohort exp Drug: MABT5102A
Repeating subcutaneous injection
Experimental: Part 2: Intravenous cohort exp Drug: MABT5102A
Repeating intravenous infusion
Placebo Comparator: Part 1: Subcutaneous cohort
Repeating subcutaneous injection
Drug: placebo
Repeating subcutaneous injection
Placebo Comparator: Part 2: Intravenous cohort
Repeating intravenous infusion
Drug: placebo
Repeating intravenous infusion

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343966

  Hide Study Locations
Locations
United States, Arizona
Hope Research Institute
Phoenix, Arizona, United States, 85050
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
Pharmacology Research Inst
Encino, California, United States, 91316
Margolin Brain Institute
Fresno, California, United States, 93720
Univ of CA San Diego; Neurosciences Comp.Alzheimer's
La Jolla, California, United States, 92037
USC School of Medicine
Los Angeles, California, United States, 90033
Pharmacology Research Inst
Newport Beach, California, United States, 92660
University of California Davis Medical System
Sacramento, California, United States, 95817
Pacific Research Network - PRN
San Diego, California, United States, 92103
Uni of California San Francisco
San Francisco, California, United States, 94117
Neurological Research Inst
Santa Monica, California, United States, 90025
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Florida
Florida Atlantic University; College of Medicine
Boca Raton, Florida, United States, 33431
Meridien Research
Brooksville, Florida, United States, 34601
Brain Matters Research, Inc.
Delray Beach, Florida, United States, 33445
Miami Jewish Health Systems; Clinical Research
Miami, Florida, United States, 33137
Collier Neurologic Specialists
Naples, Florida, United States, 34102
Compass Research
Orlando, Florida, United States, 32806
Axiom Clinical Research of Florida
Tampa, Florida, United States, 33609
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Illinois
Rush Alzheimer's Disease Cntr.
Chicago, Illinois, United States, 60612
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
IU Healthy Partners Adult Neurology Clinic
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Louisiana Research Associates
New Orleans, Louisiana, United States, 70114
United States, Missouri
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, United States, 63141
United States, New Jersey
NeuroCognitive Institute
Mount Arlington, New Jersey, United States, 07856
Memory Enhancement Center of NJ, Inc.
Toms River, New Jersey, United States, 08755
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Empire Neurology, PC
Latham, New York, United States, 12210
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester Medical Center; Monroe Community Hospital
Rochester, New York, United States, 14627
Investigational Drug Service; Univ of Rochester Medical Ctr
Rochester, New York, United States, 14642
United States, North Carolina
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607-6520
United States, Ohio
Neurology & Neuroscience Ctr of Ohio
Toledo, Ohio, United States, 43623
United States, Oregon
Clinical Trials of America, Inc.
Eugene, Oregon, United States, 97401
Summit Research Network Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
United States, South Carolina
Medical Uni of South Carolina
North Charleston, South Carolina, United States, 29425
United States, Texas
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Vermont
Clinical Neuroscience Research Associates, Inc.
Bennington, Vermont, United States, 05201
Canada, Alberta
Saibal Nandy Professional Corporation
Medicine Hat, Alberta, Canada, T1B 4E7
Canada, British Columbia
The Med Arts Health Rsrch Grp
Kelowna, British Columbia, Canada, V1Y 3G8
The Med Arts Health Rsrch Grp
Penticton, British Columbia, Canada, V2A 5C8
University of British Columbia Hospital; Division of Neurology
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Nova Scotia
Capitol District Health Authority
Halilfax, Nova Scotia, Canada, B3H 2E1
Canada, Ontario
Jbn Medical Diagnostic Services Inc.
Burlington, Ontario, Canada, L7M 4Y1
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 2V7
Providence Care Centre; Mental Health Site
Kingston, Ontario, Canada, K7L 4X3
St. Joseph's HC-Parkwood Hosp
London, Ontario, Canada, N6C 5J1
Bruyere Continuing Care
Ottawa, Ontario, Canada, K1N 5C8
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada, K9H 2P4
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, Canada, M3B 2S7
Canada, Quebec
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada, J4V 2J2
Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique
Montreal, Quebec, Canada, H1T 2M4
CHAUQ Hopital Enfant-Jesus
Quebec City, Quebec, Canada, G1J 1Z4
McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
Verdun, Quebec, Canada, H4H 1R3
France
Groupe Hospitalier Pellegrin
Bordeaux, France, 33000
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron, France, 69677
Chu Limoges
Limoges, France, 87042
Hopital Nord Laennec
Nantes, France, 44093
Hopital de Cimiez
Nice, France, 06003
Hopital Broca
Paris, France, 75013
CHU de Rouen Hopital; Service de Neurologie
Rouen, France, 76031
Hopital Hautepierre; Centre dInvestigation Clinique
Strasbourg, France, 67098
Hôpital Casselardit; Cons memoire
Toulouse, France, 31059
Germany
Studienambulanz emovis GmbH; St. Joseph Krankenhaus
Berlin, Germany, 10626
Univ Berlin; Klin fur Psychi & Psycho Charite
Berlin, Germany, 12203
Universitätsklinikum Erlangen; Augenklinik
Erlangen, Germany, 91054
Bezirkskrankenhaus Günzburg
Günzburg, Germany, 89312
Zentralinstitut fuer Seelische Gesundheit
Mannheim, Germany, 68159
Inst fur Stedien zur Psych Ges
Mannheim, Germany, 68165
Psych Klin der LMU Muenchen
Muenchen, Germany, 80336
Ludwig-Maximilians-Univ.
Munchen, Germany, 81377
Klinikum rechts der Isar der Technischen Universität München
Munchen, Germany, 81675
Villa Sauer, Praxis für; Neurologie und Psychiatrie
Siegen, Germany, 57072
Universitätsklinik Tübingen; Psychiatrie und Psychotherapie
Tubingen, Germany, 72076
Spain
Hospital General de Catalunya
San Cugat del Valles, Barcelona, Spain, 08195
Policlinica Guipuzcoa
San Sebastian, Guipuzcoa, Spain, 20009
Hospital de Cruces; Servicio de Neurologia
Barakaldo, Vizcaya, Spain, 48903
Hospital Perpetuo Socorro
Albacete, Spain, 02006
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Clinica Ruber, 4 planta; Servicio de Neurologia
Madrid, Spain, 28006
Hospital Universitario Virgen de la Macarena;
Sevilla, Spain, 41071
United Kingdom
The Rice Centre; Royal United Hospital
Bath, United Kingdom, BA1 3NG
West London Research Unit; Brentford Lodge
Brentford, United Kingdom, TW8 8DS
Royal Sussex County Hospital, CIRU Level 5
Brighton, United Kingdom, BN2 5BE
Glasgow Memory Clinic
Glasgow, United Kingdom, G20 0XA
The National Hospital for Neurology & Neurosurgery; Dementia Research Center
London, GT LON, United Kingdom, WC1N 3BG
Camden Mews Day Hospital; Camden and Islington
London, United Kingdom, NW1 9DB
Southampton General Hospital; Pharmacy
Southampton, United Kingdom, SO16 6YD
Moorgreen Hospital; Memory Assessment & Rsch Ctr
Southampton, United Kingdom, SO30 3JB
Great Western Hosp.; Kingshill Research Ctr
Swindon, United Kingdom, SN3 6BW
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Robert Paul, M.D., Ph.D. Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01343966     History of Changes
Other Study ID Numbers: ABE4869g
ABBY ( Other Identifier: Genentech )
GN00761 ( Other Identifier: Hoffmann-La Roche )
Study First Received: April 27, 2011
Last Updated: July 10, 2017

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2017