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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01224106
First received: October 14, 2010
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

This multi-center, randomized, double-blind, placebo-controlled parallel-group s tudy will evaluate the effect of gantenerumab (RO4909832) on cognition and funct ioning and the safety and pharmacokinetics in patients with prodromal Alzheimer' s Disease. Patients will be randomized to receive subcutaneous injections of eit her gantenerumab or placebo. Patients who consent to be part of the sub study wi ll undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks, with an option for an addi tional 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:
  • 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 ]
  • Change in functioning assessed with the Functional Activities Questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Change in cognition assessed with the Alzheimer Disease Assessment Scale-Cognition [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 799
Study Start Date: November 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85006
United States, California
La Jolla, California, United States, 92037
Oxnard, California, United States, 93030
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, Florida
Delray Beach, Florida, United States, 33445
Hollywood, Florida, United States, 33021
Leesburg, Florida, United States, 34748
Orlando, Florida, United States, 32806
Sarasota, Florida, United States, 34243
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Newton, Massachusetts, United States, 02459
United States, Michigan
Kalamazoo, Michigan, United States, 49048
United States, Mississippi
Hattiesburg, Mississippi, United States, 39401
United States, New Jersey
Marlton, New Jersey, United States, 08053
Princeton, New Jersey, United States, 08540
United States, New York
Orangeburg, New York, United States, 10962
Rochester, New York, United States, 14620
United States, North Carolina
Charlotte, North Carolina, United States, 28211
Raleigh, North Carolina, United States, 27607-6520
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Jenkintown, Pennsylvania, United States, 19046
Plains, Pennsylvania, United States, 18705
United States, Rhode Island
East Providence, Rhode Island, United States, 02914
Providence, Rhode Island, United States, 02906
United States, Texas
Austin, Texas, United States, 78757
Dallas, Texas, United States, 75214
United States, Utah
Salt Lake City, Utah, United States, 84106
United States, Vermont
Bennington, Vermont, United States, 05201
Argentina
Buenos Aires, Argentina, C1425BWO
Buenos Aires, Argentina, C1405BCH
Buenos Aires, Argentina, C1181ACH
Buenos Aires, Argentina, C1431FWO
Caba, Argentina, C1126AAB
Caba, Argentina, C1022AAO
Caba, Argentina, C1428AQK
Córdoba, Argentina, X5004AOA
La Plata, Argentina, B1902AJU
Australia, New South Wales
Hornsby, New South Wales, Australia, 2077
Randwick, New South Wales, Australia, 2031
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Woodville, South Australia, Australia, 5011
Australia, Victoria
Heidelberg West, Victoria, Australia, 3081
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
Belgium
Edegem, Belgium, 2650
Leuven, Belgium, 3000
Brazil
Curitiba, PR, Brazil, 80060-900
Porto Alegre, RS, Brazil, 90035-003
Porto Alegre, RS, Brazil, 90110-270
Sao Paulo, SP, Brazil, 05403-010
Sao Paulo, SP, Brazil, 05403-000
Sao Paulo, SP, Brazil, 04024-002
Canada, Nova Scotia
Kentville,, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
Peterborough, Ontario, Canada, K9H 2P4
Toronto, Ontario, Canada, M3B 2S7
Toronto, Ontario, Canada, M6M 3Z5
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V 2J2
Montreal, Quebec, Canada, H3T 1E2
Quebec City, Quebec, Canada, G1J 1Z4
Sherbrooke, Quebec, Canada, J1H1Z1
Chile
Santiago, Chile, 7560356
Santiago, Chile, 7500710
Viña de Mar, Chile, 2520997
Czech Republic
Brno, Czech Republic, 656 91
Olomouc, Czech Republic, 77521
Rychnov nad Kneznou, Czech Republic, 516 01
Denmark
Aarhus C, Denmark, 8000
Copenhagen, Denmark, 2100
Finland
Turku, Finland, 20520
France
Bobigny, France, 93009
Bordeaux, France, 33076
Bron, France, 69677
Caen, France, 14033
Lille, France, 59037
Paris, France, 75651
Rouen, France, 76031
St Herblain, France, 44800
Strasbourg, France, 67098
Toulouse, France, 31059
Germany
Berlin, Germany, 14050
Bonn, Germany, 53127
Frankfurt, Germany, 60528
Leipzig, Germany, 04107
Mannheim, Germany, 68159
Mittweida, Germany, 09648
Munich, Germany, 81675
München, Germany, 80331
Nürnberg, Germany, 90402
Rostock, Germany, 18147
Ulm, Germany, 89081
Israel
Haifa, Israel, 3109601
Ramat Gan, Israel, 52621
Italy
Modena, Emilia-Romagna, Italy, 41126
Parma, Emilia-Romagna, Italy, 43126
Brescia, Lombardia, Italy, 25100
Brescia, Lombardia, Italy, 25125
Castellanza, Lombardia, Italy, 21053
Milano, Lombardia, Italy, 20132
Milano, Lombardia, Italy, 20122
Torrette - Ancona, Marche, Italy, 60100
Firenze, Toscana, Italy, 50134
Verona, Veneto, Italy, 37126
Korea, Republic of
Gyeonggi-do, Korea, Republic of, 463-707
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 143-729
Mexico
Culiacan, Mexico, 80020
Guadalajara, Mexico, 44620
Guadalajara, Mexico, 44610
Mexico City, Mexico, 11000
Monterrey, Mexico, 64710
Monterrey, Mexico, 64460
Saltillo, Mexico, 25000
Netherlands
'S Hertogenbosch, Netherlands, 5223 GZ
Amsterdam, Netherlands, 1081 GM
Poland
Bialystok, Poland, 15-732
Bydgoszcz, Poland, 85-796
Bydgoszcz, Poland, 85-094
Poznan, Poland, 61-853
Warszawa, Poland, 01-697
Warszawa, Poland, 01-231
Portugal
Amadora, Portugal, 2720-276
Lisboa, Portugal, 1649-035
Russian Federation
Ekaterinburg, Russian Federation, 620036
Kazan, Russian Federation, 420101
Saint Petersburg, Russian Federation, 190103
Saratov, Russian Federation, 410028
St. Petersburg, Russian Federation, 194044
Spain
BArcelon, Barcelona, Spain, 08034
Terrasa, Barcelona, Spain, 08221
Barakaldo, Vizcaya, Spain, 48903
Barcelona, Spain, 08003
Barcelona, Spain, 08036
Barcelona, Spain, 08025
Madrid, Spain, 28046
Madrid, Spain, 28034
Madrid, Spain, 28040
Madrid, Spain, 28041
Valencia, Spain, 46017
Sweden
Malmoe, Sweden, SE-20502
Switzerland
Basel, Switzerland, 4031
Chêne-Bourg, Switzerland, 1225
Turkey
Antalya, Turkey, 07058
Istanbul, Turkey, 34093
Samsun, Turkey, 55139
United Kingdom
Cambridge, United Kingdom, CB2 0QQ
Cardiff, United Kingdom, CF64 2XX
Epping, United Kingdom, CM16 6TN
Glasgow, United Kingdom, G20 0XA
London, United Kingdom, W6 8RF
Newcastle, United Kingdom, NE4 5PL
Oxford, United Kingdom, OX3 9DU
Southampton, United Kingdom, SO30 3JB
Swindon, United Kingdom, SN3 6BW
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: October 20, 2014
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 October 29, 2014