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
Not yet recruiting


Geolocation is 33.612697, -112.280129

Site
Sun City
Arizona
85351
Not yet recruiting


Geolocation is 32.3312255, -111.0341183

Site
Tucson
Arizona
85741
Not yet recruiting


Geolocation is 33.6834142, -117.9073244

Site
Costa Mesa
California
92626
Not yet recruiting


Geolocation is 33.78659, -117.8750976

Site
Orange
California
92868
Not yet recruiting


Geolocation is 32.749789, -117.1676501

Site
San Diego
California
92103
Not yet recruiting


Geolocation is 34.1423899, -118.4571974

Site
Sherman Oaks
California
91403
Not yet recruiting


Geolocation is 39.8086537, -104.8337879

Site
Denver
Colorado
80239
Not yet recruiting


Geolocation is 26.4647478, -80.109357

Site
Delray Beach
Florida
33445
Active, not recruiting


Geolocation is 26.5273497, -81.8333656

Site
Ft Myers
Florida
33912
Not yet recruiting


Geolocation is 26.0197012, -80.1819268

Site
Hollywood
Florida
33021
Not yet recruiting


Geolocation is 26.5907805, -80.2432839

Site
Lake Worth
Florida
33449
Not yet recruiting


Geolocation is 28.7898508, -81.8770671

Site
Leesburg
Florida
34748
Recruiting


Geolocation is 25.8207159, -80.1819268

Site
Miami
Florida
33137
Not yet recruiting


Geolocation is 26.132433, -81.7951054

Site
Naples
Florida
34102
Not yet recruiting


Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Recruiting


Geolocation is 28.0869646, -82.4698603

Site
Tampa
Florida
33613-4706
Not yet recruiting


Geolocation is 39.7794767, -86.1700894

Site
Indianapolis
Indiana
46202
Not yet recruiting


Geolocation is 30.4192451, -91.1448981

Site
Baton Rouge
Louisiana
70808
Not yet recruiting


Geolocation is 29.9335739, -90.0326531

Site
New Orleans
Louisiana
70114
Not yet recruiting


Geolocation is 42.2766433, -85.5097226

Site
Kalamazoo
Michigan
49048
Recruiting


Geolocation is 38.6624944, -90.4785495

Site
Creve Coeur
Missouri
63141
Not yet recruiting


Geolocation is 39.9549152, -74.3822058

Site
Manchester
New Jersey
08759
Not yet recruiting


Geolocation is 40.74727, -73.9800645

Site
New York
New York
10016
Not yet recruiting


Geolocation is 41.0481178, -73.9301037

Orangeburg
New York
10962
Not yet recruiting


Geolocation is 40.555548, -74.1827119

Site
Staten Island
New York
10312
Not yet recruiting


Geolocation is 35.1660032, -80.7934798

Site
Charlotte
North Carolina
28211
Recruiting


Geolocation is 35.8409242, -78.6228504

Site
Raleigh
North Carolina
27609
Not yet recruiting


Geolocation is 36.142324, -95.956825

Site
Tulsa
Oklahoma
74104
Not yet recruiting


Geolocation is 40.1313817, -75.1370254

Site
Abington
Pennsylvania
19001
Not yet recruiting


Geolocation is 41.2737475, -75.8359645

Site
Plains
Pennsylvania
18705
Recruiting


Geolocation is 41.8164902, -71.3646236

Site
East Providence
Rhode Island
02914
Recruiting


Geolocation is 35.1212908, -89.8551818

Site
Memphis
Tennessee
38120
Not yet recruiting


Geolocation is 30.3507705, -97.7362384

Site
Austin
Texas
78757
Recruiting


Geolocation is 40.7834328, -111.7376178

Site
Salt Lake City
Utah
84108-1225
Not yet recruiting


Geolocation is 51.0662767, -114.1355032

Site
Calgary
Alberta
T2N 4Z6
Not yet recruiting


Geolocation is 49.8439404, -124.5194137

site
Powell River
British Columbia
V8A 3B6
Not yet recruiting


Geolocation is 44.6582865, -63.6700901

Site
Halifax
Nova Scotia
B3S 1M7
Recruiting


Geolocation is 45.0836805, -64.497142

Site
Kentville,
Nova Scotia
B4N 4K9
Recruiting


Geolocation is 43.391789, -79.8217953

Site
Burlington
Ontario
L7M 4Y1
Not yet recruiting


Geolocation is 44.2305468, -76.4840299

Site
Kingston
Ontario
K7L 5A2
Not yet recruiting


Geolocation is 42.9555117, -81.2257216

Site
London
Ontario
N6C 5J1
Not yet recruiting


Geolocation is 44.3073347, -78.3218108

Site
Peterborough
Ontario
K9H 2P4
Recruiting


Geolocation is 43.7585342, -79.3535081

Site
Toronto
Ontario
M3B 2S7
Active, not recruiting


Geolocation is 43.7215696, -79.3768256

Site
Toronto
Ontario
M4N 3M5
Not yet recruiting


Geolocation is 45.4827785, -75.6872156

Site
Gatineau
Quebec
J8T 8J1
Not yet recruiting


Geolocation is 45.4808565, -73.4666522

Site
Greenfield Park
Quebec
J4V 2J2
Not yet recruiting


Geolocation is 45.4976084, -73.6292768

Site
Montreal
Quebec
H3T 1E2
Not yet recruiting


Geolocation is 46.8371449, -71.226169

Site
Quebec City
Quebec
G1J 1Z4
Not yet recruiting


Geolocation is 45.4420201, -73.5800493

Site
Verdun
Quebec
H4H 1R3
Not yet recruiting


Geolocation is 46.8572658, -71.4211902

Site
Quebec
None
G3K 2P8
Not yet recruiting


Geolocation is 39.9389199, -105.0674317

Site
Culiacan
Mexico
80020
Not yet recruiting

Geolocation is 40.7626076, -81.1914571

Site
Guadalajara
Mexico
44670
Not yet recruiting

Geolocation is 38.471621239, -0.819877531

Site
Mexico City
Mexico
03600
Not yet recruiting

Geolocation is 25.66133, -100.3322478

Site
Monterrey
Mexico
64710
Not yet recruiting

Geolocation is 39.8583453, -94.0797673

Site
Monterrey
Mexico
64620
Not yet recruiting

Geolocation is 14.037805548, 101.411204932

Site
Saltillo
Mexico
25000
Not yet recruiting
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