Alzheimer's Disease Education and Referral Center

Gantenerumab for Mild Alzheimer Disease

Gantenerumab for Mild Alzheimer Disease

Overall Status: 
Recruiting
Brief Description: 

This study will evaluate the efficacy and safety of gantenerumab, an experimental drug, in people with mild Alzheimer disease.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
50 Years
90 Years
Both
No
Inclusion Criteria: 
    • Clinical diagnosis of probable mild Alzheimer disease, based on NINCDS/ADRDA criteria
    • Available caregiver who has frequent contact with the participant and can provide accurate information about his or her cognitive and functional abilities
    • Fluency in the language of the tests used at the study site
    • Adequate seeing and hearing ability to perform neuropsychological testing (eyeglasses and hearing aids are permitted)
    • If taking Alzheimer's medication, must have been on stable dose for at least 5 months prior to joining the study
Exclusion Criteria: 
    • Dementia due to a condition other than Alzheimer's, including but not limited to frontotemporal dementia, Parkinson disease, dementia with Lewy bodies, Huntington disease, or vascular dementia
    • History or presence of clinically evident vascular disease that may affect cognitive function
    • History or presence of stroke within the past 2 years or documented history of transient ischemic attack within the past year
    • History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits
    • History of schizophrenia, schizoaffective disorder, or bipolar disorder
    • Alcohol and/or substance abuse or dependence (according to the DSM-5) within the past 2 years (nicotine use is allowed)
    • History or presence of atrial fibrillation
    • Unstable or clinically significant cardiovascular disease within the past 2 years (for example, myocardial infarction, angina pectoris, or cardiac failure)
    • Uncontrolled hypertension
    • Chronic kidney disease or impaired hepatic function
Detailed Description: 

In this Phase III study, investigators will test gantenerumab, a humanized monoclonocal antibody designed to lower levels of the toxic protein beta-amyloid in the brain. Participants will receive the drug or placebo by subcutaneous (under the skin) injection every 4 weeks for about 2 years. 

Central Contact Information: 

For more information about this trial or the study sites, please contact Hoffman-LaRoche at 888-662-6728 (U.S. only) or global.rochegenetechtrials@roche.com. Reference study ID number WN28745.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.4636012, -112.0535987

Site
Phoenix
Arizona
85006
Recruiting
Name:
Phone:

Geolocation is 33.6020658, -112.280129

Site
Sun City
Arizona
85351
Recruiting
Name:
Phone:

Geolocation is 32.3312255, -111.0341183

Site
Tucson
Arizona
85741
Recruiting
Name:
Phone:

Geolocation is 33.6834142, -117.9073244

Site
Costa Mesa
California
92626
Recruiting
Name:
Phone:

Geolocation is 33.78659, -117.8750976

Site
Orange
California
92868
Recruiting
Name:
Phone:

Geolocation is 32.749789, -117.1676501

Site
San Diego
California
92103
Recruiting
Name:
Phone:

Geolocation is 34.1423899, -118.4571974

Site
Sherman Oaks
California
91403
Recruiting
Name:
Phone:

Geolocation is 39.8086537, -104.8337879

Site
Denver
Colorado
80239
Recruiting
Name:
Phone:

Geolocation is 28.5552719, -82.3878709

Site
Brooksville
Florida
34601
Not yet recruiting
Name:
Phone:

Geolocation is 26.4647478, -80.109357

Site
Delray Beach
Florida
33445
Recruiting
Name:
Phone:

Geolocation is 26.5273497, -81.8333656

Site
Ft Myers
Florida
33912
Recruiting
Name:
Phone:

Geolocation is 26.0197012, -80.1819268

Site
Hollywood
Florida
33021
Recruiting
Name:
Phone:

Geolocation is 26.5907805, -80.2432839

Site
Lake Worth
Florida
33449
Recruiting
Name:
Phone:

Geolocation is 28.810823, -81.8778582

Site
Leesburg
Florida
34748
Recruiting
Name:
Phone:

Geolocation is 25.8207159, -80.1819268

Site
Miami
Florida
33137
Recruiting
Name:
Phone:

Geolocation is 26.132433, -81.7951054

Site
Naples
Florida
34102
Not yet recruiting
Name:
Phone:

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Recruiting
Name:
Phone:

Geolocation is 29.1145775, -80.9745372

Site
Port Orange
Florida
32127
Not yet recruiting
Name:
Phone:

Geolocation is 28.0869646, -82.4698603

Site
Tampa
Florida
33613-4706
Recruiting
Name:
Phone:

Geolocation is 39.7794767, -86.1700894

Site
Indianapolis
Indiana
46202
Recruiting
Name:
Phone:

Geolocation is 30.4192451, -91.1448981

Site
Baton Rouge
Louisiana
70808
Not yet recruiting
Name:
Phone:

Geolocation is 29.9335739, -90.0326531

Site
New Orleans
Louisiana
70114
Not yet recruiting
Name:
Phone:

Geolocation is 42.2766433, -85.5097226

Site
Kalamazoo
Michigan
49048
Recruiting
Name:
Phone:

Geolocation is 38.6608855, -90.422618

Site
Creve Coeur
Missouri
63141
Recruiting
Name:
Phone:

Geolocation is 39.9549152, -74.3822058

Site
Manchester
New Jersey
08759
Recruiting
Name:
Phone:

Geolocation is 40.74727, -73.9800645

Site
New York
New York
10016
Not yet recruiting
Name:
Phone:

Geolocation is 41.0464858, -73.9495818

Site
Orangeburg
New York
10962
Not yet recruiting
Name:
Phone:

Geolocation is 40.555548, -74.1827119

Site
Staten Island
New York
10312
Recruiting
Name:
Phone:

Geolocation is 35.1660032, -80.7934798

Site
Charlotte
North Carolina
28211
Recruiting
Name:
Phone:
Lead Sponsor: 
Agency
Hoffmann-La Roche
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Clinical Trials
Study Director
Hoffmann-La Roche
Study Contact: 
NamePhoneEmail
Hoffman-LaRoche
888-662-6728 (U.S. Only)
Locations
 
 
ClinicalTrials.gov ID 
NCT02051608 (follow link to view full record on ct.gov in new window)
Official Title: 
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER, EFFICACY AND SAFETY STUDY OF GANTENERUMAB IN PATIENTS WITH MILD ALZHEIMER'S DISEASE
Study Start Date: 
March 2014
Study End Date: 
March 2019
Disease Stage: 
Early
Enrollment: 
1000