Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Gantenerumab in Patients With Prodromal Alzheimer's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01224106
First received: October 14, 2010
Last updated: February 23, 2015
Last verified: February 2015
  Purpose

This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in patients with prodromal Alzheimer's Disease. Patients will be randomized to receive subcutaneous injections of either gantenerumab or placebo. Patients who consent to be part of the sub study will undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks, with an option for an additional 2 years of treatment.


Condition Intervention Phase
Alzheimer Disease
Drug: gantenerumab
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease With Option for an Additional Two Years of Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in the Clinical Dementia Rating scale Sum of Boxes (CDR-SOB), a global measure of cognition and functional ability [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Substudy: Change in brain amyloid over time assessed with Positron Emission Tomography [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in cognition assessed with the Alzheimer Disease Assessment Scale-Cognition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in functioning assessed with the Functional Activities Questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Safety (nature and incidence of adverse events) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: gantenerumab levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 770
Study Start Date: November 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: gantenerumab
225 mg subcutaneous doses every 4 weeks for 104 weeks
Experimental: 2 Drug: gantenerumab
105 mg subcutaneous doses every 4 weeks for 104 weeks
Placebo Comparator: 3 Drug: placebo
subcutaneous doses every 4 weeks for 104 weeks

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, 50-85 years of age
  • Patients with prodromal Alzheimer's Disease who are not receiving memantine or cholinesterase inhibitors
  • Has a study partner who in the investigator's judgement has frequent and sufficient contact with the subject as to be able to provide accurate information as to the patient's cognitive and functional abilities, who agrees to provide information at clinic visits which require partner input for scale completion
  • Has had sufficient education or work experience to exclude mental retardation
  • Study partner has noticed a recent gradual decrease in patient's memory (e.g. over the last 12 months), which the patient may or may not be aware of
  • Screening MMSE score of 24 or above

Additional inclusion criteria for sub study:

  • Able and willing to travel to Positron Emission Tomography imaging center and complete the planned scanning sessions
  • Past and planned exposure to ionizing radiation not exceeding safe and permissible levels

Exclusion Criteria:

  • Other prior or current neurologic or medical disorder which may currently or during the course of the study impair cognition or psychiatric functioning
  • A history of stroke
  • A documented history of transient ischemic attack within the last 12 months
  • History of schizophrenia, schizoaffective or bipolar disorder
  • Currently meets criteria for major depression
  • Within the last 2 years, unstable or clinical significant cardiovascular disease (e.g. myocardial infarction, angina pectoris)

Additional exclusion criteria for sub study:

  • Inclusion in a research and/or medical protocol involving PET ligands or other radioactive agents within 12 months
  • Present or planned participation in a research and/or medical protocol involving PET ligands or radioactive agents other than study WN25203
  • Have planned or are planning to have exposure to ionizing radiation that in combination with the planned administration with study amyloid PET ligand would result in a cumulative exposure that exceeds local recommended exposure limits
  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: NCT01224106

Contacts
Contact: Reference Study ID Number: WN25203 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Arizona
Active, not recruiting
Phoenix, Arizona, United States, 85006
United States, California
Active, not recruiting
La Jolla, California, United States, 92037
Terminated
Oxnard, California, United States, 93030
United States, Connecticut
Active, not recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
Active, not recruiting
Delray Beach, Florida, United States, 33445
Active, not recruiting
Hollywood, Florida, United States, 33021
Active, not recruiting
Leesburg, Florida, United States, 34748
Active, not recruiting
Orlando, Florida, United States, 32806
Active, not recruiting
Sarasota, Florida, United States, 34243
Active, not recruiting
West Palm Beach, Florida, United States, 33407
United States, Georgia
Terminated
Atlanta, Georgia, United States, 30308
United States, Indiana
Completed
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Active, not recruiting
Newton, Massachusetts, United States, 02459
United States, Michigan
Active, not recruiting
Kalamazoo, Michigan, United States, 49048
United States, Mississippi
Active, not recruiting
Hattiesburg, Mississippi, United States, 39401
United States, New Jersey
Terminated
Marlton, New Jersey, United States, 08053
Active, not recruiting
Princeton, New Jersey, United States, 08540
United States, New York
Active, not recruiting
Orangeburg, New York, United States, 10962
Active, not recruiting
Rochester, New York, United States, 14620
United States, North Carolina
Active, not recruiting
Charlotte, North Carolina, United States, 28211
Terminated
Raleigh, North Carolina, United States, 27607-6520
United States, Oregon
Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Terminated
Jenkintown, Pennsylvania, United States, 19046
Active, not recruiting
Plains, Pennsylvania, United States, 18705
United States, Rhode Island
Active, not recruiting
East Providence, Rhode Island, United States, 02914
Active, not recruiting
Providence, Rhode Island, United States, 02906
United States, Texas
Active, not recruiting
Austin, Texas, United States, 78757
Active, not recruiting
Dallas, Texas, United States, 75214
United States, Utah
Terminated
Salt Lake City, Utah, United States, 84106
United States, Vermont
Active, not recruiting
Bennington, Vermont, United States, 05201
Argentina
Active, not recruiting
Buenos Aires, Argentina, C1405BCH
Active, not recruiting
Buenos Aires, Argentina, C1425BWO
Active, not recruiting
Buenos Aires, Argentina, C1181ACH
Active, not recruiting
Buenos Aires, Argentina, C1431FWO
Active, not recruiting
Caba, Argentina, C1428AQK
Terminated
Caba, Argentina, C1022AAO
Completed
Caba, Argentina, C1126AAB
Active, not recruiting
Córdoba, Argentina, X5004AOA
Completed
La Plata, Argentina, B1902AJU
Australia, New South Wales
Active, not recruiting
Hornsby, New South Wales, Australia, 2077
Completed
Randwick, New South Wales, Australia, 2031
Australia, South Australia
Active, not recruiting
Adelaide, South Australia, Australia, 5000
Active, not recruiting
Woodville, South Australia, Australia, 5011
Australia, Victoria
Active, not recruiting
Heidelberg West, Victoria, Australia, 3081
Australia, Western Australia
Active, not recruiting
Nedlands, Western Australia, Australia, 6009
Belgium
Terminated
Edegem, Belgium, 2650
Active, not recruiting
Leuven, Belgium, 3000
Brazil
Active, not recruiting
Curitiba, PR, Brazil, 80060-900
Completed
Porto Alegre, RS, Brazil, 90035-003
Active, not recruiting
Porto Alegre, RS, Brazil, 90110-270
Active, not recruiting
Sao Paulo, SP, Brazil, 04024-002
Completed
Sao Paulo, SP, Brazil, 05403-010
Not yet recruiting
Sao Paulo, SP, Brazil, 05403-000
Canada, Nova Scotia
Active, not recruiting
Kentville,, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
Active, not recruiting
Peterborough, Ontario, Canada, K9H 2P4
Active, not recruiting
Toronto, Ontario, Canada, M6M 3Z5
Active, not recruiting
Toronto, Ontario, Canada, M3B 2S7
Canada, Quebec
Active, not recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Completed
Montreal, Quebec, Canada, H3T 1E2
Completed
Quebec City, Quebec, Canada, G1J 1Z4
Terminated
Sherbrooke, Quebec, Canada, J1H1Z1
Chile
Active, not recruiting
Santiago, Chile, 7500710
Active, not recruiting
Santiago, Chile, 7560356
Terminated
Viña de Mar, Chile, 2520997
Czech Republic
Active, not recruiting
Brno, Czech Republic, 656 91
Terminated
Olomouc, Czech Republic, 77521
Active, not recruiting
Rychnov nad Kneznou, Czech Republic, 516 01
Denmark
Active, not recruiting
Aarhus C, Denmark, 8000
Active, not recruiting
Copenhagen, Denmark, 2100
Finland
Active, not recruiting
Turku, Finland, 20520
France
Active, not recruiting
Bobigny, France, 93009
Active, not recruiting
Bordeaux, France, 33076
Active, not recruiting
Bron, France, 69677
Completed
Caen, France, 14033
Active, not recruiting
Lille, France, 59037
Active, not recruiting
Paris, France, 75651
Active, not recruiting
Rouen, France, 76031
Recruiting
St Herblain, France, 44800
Active, not recruiting
Strasbourg, France, 67098
Active, not recruiting
Toulouse, France, 31059
Germany
Active, not recruiting
Berlin, Germany, 14050
Active, not recruiting
Bonn, Germany, 53127
Completed
Frankfurt, Germany, 60528
Active, not recruiting
Leipzig, Germany, 04107
Active, not recruiting
Mannheim, Germany, 68159
Active, not recruiting
Mittweida, Germany, 09648
Active, not recruiting
Munich, Germany, 81675
Active, not recruiting
München, Germany, 80331
Active, not recruiting
Nürnberg, Germany, 90402
Active, not recruiting
Rostock, Germany, 18147
Active, not recruiting
Ulm, Germany, 89081
Israel
Terminated
Haifa, Israel, 3109601
Terminated
Ramat Gan, Israel, 52621
Italy
Active, not recruiting
Modena, Emilia-Romagna, Italy, 41126
Completed
Parma, Emilia-Romagna, Italy, 43126
Active, not recruiting
Brescia, Lombardia, Italy, 25125
Active, not recruiting
Brescia, Lombardia, Italy, 25100
Active, not recruiting
Castellanza, Lombardia, Italy, 21053
Active, not recruiting
Milano, Lombardia, Italy, 20132
Active, not recruiting
Milano, Lombardia, Italy, 20122
Active, not recruiting
Torrette - Ancona, Marche, Italy, 60100
Active, not recruiting
Firenze, Toscana, Italy, 50134
Terminated
Verona, Veneto, Italy, 37126
Korea, Republic of
Active, not recruiting
Gyeonggi-do, Korea, Republic of, 463-707
Completed
Seoul, Korea, Republic of, 135-710
Active, not recruiting
Seoul, Korea, Republic of, 137-701
Active, not recruiting
Seoul, Korea, Republic of, 138-736
Active, not recruiting
Seoul, Korea, Republic of, 143-729
Mexico
Active, not recruiting
Culiacan, Mexico, 80020
Active, not recruiting
Guadalajara, Mexico, 44620
Active, not recruiting
Guadalajara, Mexico, 44610
Completed
Mexico City, Mexico, 11000
Recruiting
Monterrey, Mexico, 64710
Recruiting
Monterrey, Mexico, 64460
Active, not recruiting
Saltillo, Mexico, 25000
Netherlands
Active, not recruiting
'S Hertogenbosch, Netherlands, 5223 GZ
Active, not recruiting
Amsterdam, Netherlands, 1081 GM
Poland
Completed
Bialystok, Poland, 15-732
Terminated
Bydgoszcz, Poland, 85-094
Active, not recruiting
Bydgoszcz, Poland, 85-796
Active, not recruiting
Poznań, Poland, 61-853
Active, not recruiting
Warszawa, Poland, 01-697
Active, not recruiting
Warszawa, Poland, 01-231
Portugal
Active, not recruiting
Amadora, Portugal, 2720-276
Active, not recruiting
Lisboa, Portugal, 1649-035
Russian Federation
Completed
Ekaterinburg, Russian Federation, 620036
Active, not recruiting
Kazan, Russian Federation, 420101
Active, not recruiting
Saint Petersburg, Russian Federation, 190103
Active, not recruiting
Saratov, Russian Federation, 410028
Active, not recruiting
St. Petersburg, Russian Federation, 194044
Spain
Active, not recruiting
BArcelon, Barcelona, Spain, 08034
Active, not recruiting
Terrasa, Barcelona, Spain, 08221
Active, not recruiting
Barakaldo, Vizcaya, Spain, 48903
Active, not recruiting
Barcelona, Spain, 08025
Active, not recruiting
Barcelona, Spain, 08036
Active, not recruiting
Barcelona, Spain, 08003
Active, not recruiting
Madrid, Spain, 28046
Active, not recruiting
Madrid, Spain, 28034
Terminated
Madrid, Spain, 28040
Active, not recruiting
Madrid, Spain, 28041
Active, not recruiting
Valencia, Spain, 46017
Sweden
Active, not recruiting
Malmoe, Sweden, SE-20502
Switzerland
Active, not recruiting
Basel, Switzerland, 4031
Active, not recruiting
Chêne-Bourg, Switzerland, 1225
Turkey
Completed
Antalya, Turkey, 07058
Active, not recruiting
Istanbul, Turkey, 34093
Active, not recruiting
Samsun, Turkey, 55139
United Kingdom
Active, not recruiting
Cambridge, United Kingdom, CB2 0QQ
Active, not recruiting
Cardiff, United Kingdom, CF64 2XX
Active, not recruiting
Epping, United Kingdom, CM16 6TN
Active, not recruiting
Glasgow, United Kingdom, G20 0XA
Active, not recruiting
London, United Kingdom, W6 8RF
Active, not recruiting
Newcastle, United Kingdom, NE4 5PL
Terminated
Oxford, United Kingdom, OX3 9DU
Active, not recruiting
Southampton, United Kingdom, SO30 3JB
Completed
Swindon, United Kingdom, SN3 6BW
Active, not recruiting
Warrington, United Kingdom, WA2 8WA
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01224106     History of Changes
Other Study ID Numbers: WN25203, 2010-019895-66
Study First Received: October 14, 2010
Last Updated: February 23, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 25, 2015