Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)



Status:Recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 90
Updated:3/2/2019
Start Date:June 6, 2018
End Date:March 2, 2023
Contact:Reference Study ID Number: WN29922 www.roche.com/about_roche/roche_worldwide.htm
Email:Global-Roche-Genentech-Trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

Use our guide to learn which trials are right for you!

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the
efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to
mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible
participants will be randomized 1:1 to receive either subcutaneous (SC) injection of
gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the
double blind period at week 104. Participants will then be offered to enter into an
open-label extension (OLE). Participants not willing to go to the OLE will participate in a
long term follow-up period for up to 50 weeks after the last gantenerumab dose.


Key Inclusion criteria:

- Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical
criteria for probable AD dementia or prodromal AD (consistent with the NIAAA
diagnostic criteria and guidelines for mild cognitive impairment)

- Evidence of the AD pathological process, as confirmed by CSF or amyloid PET scan

- Demonstrated abnormal memory function

- MMSE score greater than or equal to 22 (≥ 22)

- Clinical dementia rating-global score (CDR-GS) of 0.5 or 1.0

- Availability of a reliable study partner who accepts to participate in study
procedures throughout the 2 years duration of study

- If receiving symptomatic AD medications, the dosing regimen must have been stable for
3 months prior to baseline and until randomization.

- For enrollment in the China extension, patients must have residence in mainland China,
Hong Kong, or Taiwan and be of Chinese ancestry.

Key Exclusion criteria:

- Any evidence of a condition other than AD that may affect cognition

- History of schizophrenia, schizoaffective disorder, major depression, or bipolar
disorder

- History or presence of clinically evident systemic vascular disease that in the
opinion of the investigator has the potential to affect cognitive function

- History or presence of clinically evident cerebrovascular disease

- At risk for suicide in the opinion of the investigator

- Patients with evidence of folic acid deficiency

- Alcohol and/or substance abuse or dependants in past 2 years

- Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities

- Any contraindications to brain MRI

- Unstable or clinically significant cardiovascular, kidney or liver disease

- Uncontrolled hypertension
We found this trial at
65
sites
?
mi
from
Sherman Oaks, CA
Click here to add this to my saved trials
3924 9th Avenue West
Bradenton, Florida 34205
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
?
mi
from
New London, CT
Click here to add this to my saved trials
2450 E. River Road
Tucson, Arizona 85718
520-320-2147
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
1100 N. St. Francis
Wichita, Kansas 67214
316-291-4774
?
mi
from
Wichita, KS
Click here to add this to my saved trials
811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlantis, Florida 33462
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78757
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bellevue, Washington 98007
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
Bellflower, California 90706
?
mi
from
Bellflower, CA
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
17998 Chesterfield Airport Road
Chesterfield, Missouri 63005
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
5841 South Maryland Avenue
Chicago, Illinois 60637
?
mi
from
Chicago, IL
Click here to add this to my saved trials
7196 North Lake Drive
Columbus, Georgia 31909
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
801 Monterey Street
Coral Gables, Florida 33134
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
7515 Greenville Avenue
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
438 Victoria Street
Darlinghurst, New South Wales 2010
?
mi
from
Darlinghurst,
Click here to add this to my saved trials
1 Elizabeth Place
Dayton, Ohio 45417
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Delray Beach, Florida 33445
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
Flowood, Mississippi 39232
?
mi
from
Flowood, MS
Click here to add this to my saved trials
Fort Wayne, Indiana 46805
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
Gainesville, Georgia 30501
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
Indianapolis, Indiana 46256
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
2515 McCabe Way
Irvine, California 92614
?
mi
from
Irvine, CA
Click here to add this to my saved trials
?
mi
from
Irving, TX
Click here to add this to my saved trials
Jenkintown, Pennsylvania 19046
?
mi
from
Jenkintown, PA
Click here to add this to my saved trials
Kissimmee, Florida 34759
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
Knoxville, Tennessee 37920
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lake Success, New York 11042
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
Lake Worth, Florida 33449
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
Madison, Wisconsin 53705
?
mi
from
Madison, WI
Click here to add this to my saved trials
Mount Arlington, New Jersey 07856
?
mi
from
Mount Arlington, NJ
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia 23507
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Norwalk, Connecticut 06851
?
mi
from
Norwalk, CT
Click here to add this to my saved trials
Norwich, Connecticut 06360
?
mi
from
Norwich, CT
Click here to add this to my saved trials
Oceanside, California 92056
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
14860 Roscoe Boulevard
Panorama City, California 91402
?
mi
from
Panorama City, CA
Click here to add this to my saved trials
2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Port Royal, South Carolina 29935
?
mi
from
Port Royal, SC
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
Raleigh, North Carolina 27609
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Richmond, Virginia 23226
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Riverside, California 92506
?
mi
from
Riverside, CA
Click here to add this to my saved trials
2800 L Street
Sacramento, California 95816
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Salt Lake City, Utah 84107
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Sebastopol, California 95472
?
mi
from
Sebastopol, CA
Click here to add this to my saved trials
256 Bunn Drive
South Miami, Florida 33143
?
mi
from
South Miami, FL
Click here to add this to my saved trials
801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Toms River, New Jersey 08757
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
1060 East Foothill Boulevard
Upland, California 91786
?
mi
from
Upland, CA
Click here to add this to my saved trials
West Long Branch, New Jersey 07764
?
mi
from
West Long Branch, NJ
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19090
?
mi
from
Willow Grove, PA
Click here to add this to my saved trials
Winfield, Illinois 60190
?
mi
from
Winfield, IL
Click here to add this to my saved trials