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

July 10, 2017 updated by: Genentech, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

448

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Subcutaneous cohort exp
Drug: MABT5102A
Repeating subcutaneous injection
Drug: MABT5102A
Repeating intravenous infusion
Experimental: Part 2: Intravenous cohort exp
Drug: MABT5102A
Repeating subcutaneous injection
Drug: MABT5102A
Repeating intravenous infusion
Placebo Comparator: Part 1: Subcutaneous cohort
Repeating subcutaneous injection
Drug: placebo
Repeating subcutaneous injection
Drug: placebo
Repeating intravenous infusion
Placebo Comparator: Part 2: Intravenous cohort
Repeating intravenous infusion
Drug: placebo
Repeating subcutaneous injection
Drug: placebo
Repeating intravenous infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Robert Paul, M.D., Ph.D., Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2011

Primary Completion (Actual)

February 28, 2014

Study Completion (Actual)

February 28, 2014

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (Estimate)

April 28, 2011

Study Record Updates

Last Update Posted (Actual)

July 12, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABE4869g
  • ABBY (Other Identifier: Genentech)
  • GN00761 (Other Identifier: Hoffmann-La Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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