Alzheimer's Disease Education and Referral Center

Gantenerumab for Mild Alzheimer Disease

Gantenerumab for Mild Alzheimer Disease

Overall Status: 
Active, not 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 MarkerCityStateZip CodePrimary Contact

Geolocation is 33.5636878, -112.0595603

Phoenix
Arizona
85020

Geolocation is 33.6020658, -112.280129

Sun City
Arizona
85351

Geolocation is 32.3395031, -110.9864294

Tucson
Arizona
85704

Geolocation is 33.6834142, -117.9073244

Costa Mesa
California
92626

Geolocation is 33.78659, -117.8750976

Orange
California
92868

Geolocation is 32.749789, -117.1676501

San Diego
California
92103

Geolocation is 34.1423899, -118.4571974

Sherman Oaks
California
91403

Geolocation is 39.8086537, -104.8337879

Denver
Colorado
80239

Geolocation is 28.5552719, -82.3878709

Brooksville
Florida
34601

Geolocation is 26.4647478, -80.109357

Delray Beach
Florida
33445

Geolocation is 26.5273497, -81.8333656

Ft Myers
Florida
33912

Geolocation is 26.0197012, -80.1819268

Hollywood
Florida
33021

Geolocation is 26.5907805, -80.2432839

Lake Worth
Florida
33449

Geolocation is 25.8207159, -80.1819268

Miami
Florida
33137

Geolocation is 26.132433, -81.7951054

Naples
Florida
34102

Geolocation is 28.5085825, -81.3564411

Orlando
Florida
32806

Geolocation is 29.1145775, -80.9745372

Port Orange
Florida
32127

Geolocation is 28.0869646, -82.4698603

Tampa
Florida
33613-4706

Geolocation is 28.9121162, -81.986206

The Villages
Florida
32162

Geolocation is 39.7794767, -86.1700894

Indianapolis
Indiana
46202

Geolocation is 30.4192451, -91.1448981

Baton Rouge
Louisiana
70808

Geolocation is 29.9335739, -90.0326531

New Orleans
Louisiana
70114

Geolocation is 42.3238865, -85.5869352

Kalamazoo
Michigan
49048

Geolocation is 38.6608855, -90.422618

Creve Coeur
Missouri
63141

Geolocation is 39.9549152, -74.3822058

Manchester
New Jersey
08759

Geolocation is 39.9746567, -74.1469552

Toms River
New Jersey
08775

Geolocation is 41.0464858, -73.9495818

Orangeburg
New York
10962

Geolocation is 40.555548, -74.1827119

Staten Island
New York
10312

Geolocation is 35.1097782, -80.771321

Charlotte
North Carolina
28270

Geolocation is 35.8409242, -78.6228504

Raleigh
North Carolina
27609

Geolocation is 36.142324, -95.956825

Tulsa
Oklahoma
74104

Geolocation is 41.2737475, -75.8359645

Plains
Pennsylvania
18705

Geolocation is 40.1439985, -75.1157286

Willow Grove
Pennsylvania
19090

Geolocation is 41.8164902, -71.3646236

East Providence
Rhode Island
02914

Geolocation is 35.1376546, -89.7661527

Cordova
Tennessee
38018

Geolocation is 30.3568213, -97.730807

Austin
Texas
78757

Geolocation is 40.7834328, -111.7376178

Salt Lake City
Utah
84108

Geolocation is 51.0662767, -114.1355032

Calgary
Alberta
T2N 4Z6

Geolocation is 49.8439404, -124.5194137

Powell River
British Columbia
V8A 3B6

Geolocation is 44.6582865, -63.6700901

Halifax
Nova Scotia
B3S 1M7

Geolocation is 45.0836805, -64.497142

Kentville,
Nova Scotia
B4N 4K9

Geolocation is 43.391789, -79.8217953

Burlington
Ontario
L7M 4Y1

Geolocation is 44.2305468, -76.4840299

Kingston
Ontario
K7L 5A2

Geolocation is 42.9555117, -81.2257216

London
Ontario
N6C 5J1

Geolocation is 44.3073347, -78.3218108

Peterborough
Ontario
K9H 2P4

Geolocation is 43.7585342, -79.3535081

Toronto
Ontario
M3B 2S7

Geolocation is 43.7215696, -79.3768256

Toronto
Ontario
M4N 3M5

Geolocation is 45.4827785, -75.6872156

Gatineau
Quebec
J8T 8J1

Geolocation is 45.4808565, -73.4666522

Greenfield Park
Quebec
J4V 2J2

Geolocation is 45.4976084, -73.6292768

Montreal
Quebec
H3T 1E2

Geolocation is 46.8371449, -71.226169

Quebec City
Quebec
G1J 1Z4

Geolocation is 45.4420201, -73.5800493

Verdun
Quebec
H4H 1R3

Geolocation is 46.8572658, -71.4211902

Quebec
G3K 2P8
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