Alzheimer's Disease Education and Referral Center

Gantenerumab for Prodromal Alzheimer's Disease

Gantenerumab for Prodromal Alzheimer's Disease

Overall Status: 
Recruiting
Brief Description: 

This Phase III study will evaluate the safety and efficacy of the experimental drug gantenerumab on cognition and functioning in people with prodromal (very early stage) Alzheimer's disease. Participants will be randomized to receive subcutaneous (under the skin) injections of either gantenerumab or a placebo. Those who consent to be part of the substudy will undergo positron emission tomography (PET) scanning to assess brain amyloid levels. The anticipated treatment time is 2 years.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
50 Years
85 Years
Both
No
Inclusion Criteria: 
    • People with prodromal (very early stage) Alzheimer's disease who are not taking memantine or cholinesterase inhibitors
    • Study partner who has frequent, sufficient contact with the subject and can provide accurate information about his or her cognitive and functional abilities at clinic visits
    • Study partner has noticed recent gradual decrease in person's memory, which the person may or may not be aware of
    • Sufficient education or work experience to exclude mental retardation
    •  Mini Mental State Examination score of 24 or higher

    Additional inclusion criteria for substudy

    • Able and willing to travel to PET imaging center and complete scanning sessions
    • Past or planned exposure to ionizing radiation not exceeding safe and permissible levels
Exclusion Criteria: 
    • Other prior or current neurologic or medical disorder that may impair cognition or psychiatric functioning
    • History of stroke; transient ischemic attack within the last 12 months; schizophrenia, schizoaffective or bipolar disorder; current major depression
    • Unstable or clinical significant cardiovascular disease within the past 2 years (for example, myocardial infarction, angina pectoris)

    Additional exclusion criteria for substudy

    • Inclusion in research and/or medical protocol involving PET ligands or other radioactive agents within the past 12 months
    • Present or planned participation in research and/or medical protocol involving PET ligands or radioactive agents other than gantenerumab
    • Past or planned exposure to ionizing radiation that, in combination with the study amyloid PET ligand, would result in cumulative exposure that exceeds recommended exposure limits
Detailed Description: 

In this study, investigators will test two doses of gantenerumab and compare the drug's effects to those of a placebo. Gantenerumab is a humanized monoclonocal antibody designed to lower levels of the toxic protein beta-amyloid in the brain. It will be administered as a subcutaneous (under the skin) injection. Study time is 2 years, with an option for an additional 2 years of treatment.

Central Contact Information: 

For more information about this study or study sites, please call 888-662-6728 (toll-free; U.S. only) or email genentechclinicaltrials@druginfo.com. Reference study number WN25203.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.4636012, -112.0535987

Site
Phoenix
Arizona
85006
Active, not recruiting
Name:
Phone:

Geolocation is 32.8328112, -117.2712717

Site
La Jolla
California
92037
Active, not recruiting
Name:
Phone:

Geolocation is 34.2054029, -119.1681373

Site
Oxnard
California
93030
Terminated
Name:
Phone:

Geolocation is 41.3052226, -72.9268626

Site
New Haven
Connecticut
06510
Active, not recruiting
Name:
Phone:

Geolocation is 26.4647478, -80.109357

Site
Delray Beach
Florida
33445
Active, not recruiting
Name:
Phone:

Geolocation is 26.0197012, -80.1819268

Site
Hollywood
Florida
33021
Active, not recruiting
Name:
Phone:

Geolocation is 28.810823, -81.8778582

Site
Leesburg
Florida
34748
Active, not recruiting
Name:
Phone:

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Active, not recruiting
Name:
Phone:

Geolocation is 27.4081935, -82.5294065

Site
Sarasota
Florida
34243
Active, not recruiting
Name:
Phone:

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Active, not recruiting
Name:
Phone:

Geolocation is 33.7717008, -84.3726049

Site
Atlanta
Georgia
30308
Terminated
Name:
Phone:

Geolocation is 39.7794767, -86.1700894

Site
Indianapolis
Indiana
46202
Completed
Name:
Phone:

Geolocation is 42.3028239, -71.1864397

Site
Newton
Massachusetts
02459
Active, not recruiting
Name:
Phone:

Geolocation is 42.2766433, -85.5097226

Site
Kalamazoo
Michigan
49048
Active, not recruiting
Name:
Phone:

Geolocation is 31.3271189, -89.2903392

Site
Hattiesburg
Mississippi
39401
Active, not recruiting
Name:
Phone:

Geolocation is 39.8912248, -74.9218324

Site
Marlton
New Jersey
08053
Terminated
Name:
Phone:

Geolocation is 40.3572976, -74.6672226

Site
Princeton
New Jersey
08540
Active, not recruiting
Name:
Phone:

Geolocation is 41.0464858, -73.9495818

Site
Orangeburg
New York
10962
Active, not recruiting
Name:
Phone:

Geolocation is 43.1301942, -77.6020569

Site
Rochester
New York
14620
Active, not recruiting
Name:
Phone:

Geolocation is 35.1660032, -80.7934798

Site
Charlotte
North Carolina
28211
Active, not recruiting
Name:
Phone:

Geolocation is 35.8019142, -78.6875364

Site
Raleigh
North Carolina
27607-6520
Terminated
Name:
Phone:

Geolocation is 45.4874111, -122.6875541

Site
Portland
Oregon
97239
Active, not recruiting
Name:
Phone:

Geolocation is 40.0959438, -75.1251743

Site
Jenkintown
Pennsylvania
19046
Terminated
Name:
Phone:

Geolocation is 41.2737475, -75.8359645

Site
Plains
Pennsylvania
18705
Active, not recruiting
Name:
Phone:

Geolocation is 41.8164902, -71.3646236

Site
East Providence
Rhode Island
02914
Active, not recruiting
Name:
Phone:

Geolocation is 41.8396817, -71.3883751

Site
Providence
Rhode Island
02906
Active, not recruiting
Name:
Phone:

Geolocation is 30.3568213, -97.730807

Site
Austin
Texas
78757
Active, not recruiting
Name:
Phone:

Geolocation is 32.824251, -96.7440467

Site
Dallas
Texas
75214
Active, not recruiting
Name:
Phone:

Geolocation is 40.7078639, -111.8508966

Site
Salt Lake City
Utah
84106
Terminated
Name:
Phone:

Geolocation is 42.8781345, -73.1967741

Site
Bennington
Vermont
05201
Active, not recruiting
Name:
Phone:

Geolocation is 45.0836805, -64.497142

Site
Kentville,
Nova Scotia
B4N 4K9
Active, not recruiting
Name:
Phone:

Geolocation is 44.3073347, -78.3218108

Site
Peterborough
Ontario
K9H 2P4
Active, not recruiting
Name:
Phone:

Geolocation is 43.698592, -79.4751345

Site
Toronto
Ontario
M6M 3Z5
Active, not recruiting
Name:
Phone:

Geolocation is 43.7585342, -79.3535081

Site
Toronto
Ontario
M3B 2S7
Active, not recruiting
Name:
Phone:

Geolocation is 45.4808565, -73.4666522

Site
Greenfield Park
Quebec
J4V 2J2
Active, not recruiting
Name:
Phone:

Geolocation is 45.4976084, -73.6292768

Site
Montreal
Quebec
H3T 1E2
Completed
Name:
Phone:

Geolocation is 46.8371449, -71.226169

Site
Quebec City
Quebec
G1J 1Z4
Completed
Name:
Phone:

Geolocation is 45.3945049, -71.8975156

Site
Sherbrooke
Quebec
J1H1Z1
Terminated
Name:
Phone:

Geolocation is 39.9389199, -105.0674317

Site
Culiacan
None
80020
Active, not recruiting
Name:
Phone:

Geolocation is 40.5741344, -81.2188355

Site
Guadalajara
None
44620
Active, not recruiting
Name:
Phone:

Geolocation is 40.5608106, -81.7994697

Site
Guadalajara
None
44610
Recruiting
Name:
Phone:

Geolocation is 32.9110927, -117.1053447

Site
Mexico City
None
11000
Completed
Name:
Phone:

Geolocation is 25.6866142, -100.3161126

Site
Monterrey
None
64710
Active, not recruiting
Name:
Phone:

Geolocation is 25.6866142, -100.3161126

Site
Monterrey
None
64460
Active, not recruiting
Name:
Phone:

Geolocation is 25.4267244, -100.9954254

Site
Saltillo
None
25000
Active, not recruiting
Name:
Phone:
Lead Sponsor: 
Agency
Hoffmann-La Roche
Collaborator Sponsor: 
Agency
None
Facility Investigators: 
RoleAffiliation
Study Director
Hoffmann-La Roche
Study Contact: 
NamePhoneEmail
Hoffman-LaRoche
888-662-6728 (U.S. only)
Locations
 
 
ClinicalTrials.gov ID 
NCT01224106 (follow link to view full record on ct.gov in new window)
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
Study Start Date: 
November 2010
Study End Date: 
April 2016
Disease Stage: 
Early
Enrollment: 
770