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
ClinicalTrials.gov Identifier:
NCT01343966
First received: April 27, 2011
Last updated: July 7, 2014
Last verified: July 2014
  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 Blind (Subject, 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:

Primary Outcome Measures:
  • Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score [ Time Frame: From baseline to Week 73 ] [ Designated as safety issue: No ]
  • Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score [ Time Frame: From baseline to Week 73 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: April 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: MABT5102A
Repeating subcutaneous injection
Drug: placebo
Repeating subcutaneous injection
Experimental: B Drug: MABT5102A
Repeating intravenous infusion
Drug: placebo
Repeating intravenous infusion

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable AD according to the NINCDS-ADRDA criteria
  • MMSE score of 18-26 points at screening
  • 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
Phoenix, Arizona, United States, 85050
Scottsdale, Arizona, United States, 85259
United States, California
Encino, California, United States, 91316
Fresno, California, United States, 93720
La Jolla, California, United States, 92037
Los Angeles, California, United States, 90033
Newport Beach, California, United States, 92660
Sacramento, California, United States, 95817
San Diego, California, United States, 92103
San Francisco, California, United States, 94117
Santa Monica, California, United States, 90025
United States, Connecticut
New Haven, Connecticut, United States, 06520-8063
United States, Florida
Boca Raton, Florida, United States, 33431
Brooksville, Florida, United States, 34601
Delray Beach, Florida, United States, 33445
Miami, Florida, United States, 33137
Naples, Florida, United States, 34102
Orlando, Florida, United States, 32806
Tampa, Florida, United States, 33609
West Palm Beach, Florida, United States, 33407
United States, Illinois
Chicago, Illinois, United States, 60612
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Louisiana
New Orleans, Louisiana, United States, 70114
United States, Missouri
Creve Coeur, Missouri, United States, 63141
United States, New Jersey
Mount Arlington, New Jersey, United States, 07856
Toms River, New Jersey, United States, 08755
United States, New York
Albany, New York, United States, 12208
Latham, New York, United States, 12210
New York, New York, United States, 10032
Rochester, New York, United States, 14620
Rochester, New York, United States, 14642
United States, North Carolina
Raleigh, North Carolina, United States, 27607-6520
United States, Ohio
Toledo, Ohio, United States, 43623
United States, Oregon
Eugene, Oregon, United States, 97401
Portland, Oregon, United States, 97210
United States, Pennsylvania
Jenkintown, Pennsylvania, United States, 19046
United States, South Carolina
North Charleston, South Carolina, United States, 29425
United States, Texas
Houston, Texas, United States, 77030
United States, Vermont
Bennington, Vermont, United States, 05201
Canada, Alberta
Medicine Hat, Alberta, Canada, T1B 4E7
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 3G8
Penticton, British Columbia, Canada, V2A 5C8
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Nova Scotia
Halilfax, Nova Scotia, Canada, B3H 2E1
Canada, Ontario
Burlington, Ontario, Canada, L7M 4Y1
Kingston, Ontario, Canada, K7L 5G2
Kingston, Ontario, Canada, K7L 4X3
London, Ontario, Canada, N6C 5J1
Ottawa, Ontario, Canada, K1N 5C8
Peterborough, Ontario, Canada, K9H 2P4
Toronto, Ontario, Canada, M5T 2S8
Toronto, Ontario, Canada, M3B 2S7
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V 2J2
Montreal, Quebec, Canada, H1T 2M4
Quebec City, Quebec, Canada, G1J 1Z4
Verdun, Quebec, Canada, H4H 1R3
France
Bordeaux, France, 33000
Bron, France, 69677
Limoges, France, 87042
Nantes, France, 44093
Nice, France, 06003
Paris, France, 75013
Rouen, France, 76031
Strasbourg, France, 67098
Toulouse, France, 31059
Germany
Berlin, Germany, 14050
Berlin, Germany, 10626
Erlangen, Germany, 91054
Frankfurt, Germany, 60528
Günzburg, Germany, 89312
Mannheim, Germany, 68165
Mannheim, Germany, 68159
Muenchen, Germany, 80336
Munchen, Germany, 81377
München, Germany, 81675
Siegen, Germany, 57072
Tubingen, Germany, 72076
Spain
Elche, Alicante, Spain, 03203
San Cugat del Valles, Barcelona, Spain, 08195
San Sebastian, Guipuzcoa, Spain, 20009
Barakaldo, Vizcaya, Spain, 48903
Albacete, Spain, 02006
Barcelona, Spain, 08035
Madrid, Spain, 28905
Madrid, Spain, 28006
Madrid, Spain, 28040
Sevilla, Spain, 41071
United Kingdom
Bath, United Kingdom, BA1 3NG
Belfast, United Kingdom, BT9 7AB
Brentford, United Kingdom, TW8 8DS
Brighton, United Kingdom, BN2 5BE
Glasgow, United Kingdom, G20 0XA
London, United Kingdom, NW1 9DB
London, GT LON, United Kingdom, WC1N 3BG
Southampton, United Kingdom, SO16 6YD
Southampton, United Kingdom, SO30 3JB
Swindon, United Kingdom, SN3 6BW
Sponsors and Collaborators
Genentech
Investigators
Study Director: Robert Paul, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01343966     History of Changes
Other Study ID Numbers: ABE4869g, ABBY, GN00761
Study First Received: April 27, 2011
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014