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)

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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
7515 Greenville Avenue
Dallas, Texas 75231
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3924 9th Avenue West
Bradenton, Florida 34205
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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...
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342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
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1100 N. St. Francis
Wichita, Kansas 67214
316-291-4774
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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...
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Atlantis, Florida 33462
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Austin, Texas 78731
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Austin, Texas 78757
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Bellevue, Washington 98007
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Bellflower, California 90706
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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...
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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17998 Chesterfield Airport Road
Chesterfield, Missouri 63005
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5841 South Maryland Avenue
Chicago, Illinois 60637
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7196 North Lake Drive
Columbus, Georgia 31909
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801 Monterey Street
Coral Gables, Florida 33134
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438 Victoria Street
Darlinghurst, New South Wales 2010
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1 Elizabeth Place
Dayton, Ohio 45417
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Delray Beach, Florida 33445
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Flowood, Mississippi 39232
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Fort Wayne, Indiana 46805
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Gainesville, Georgia 30501
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Indianapolis, Indiana 46256
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2515 McCabe Way
Irvine, California 92614
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Jenkintown, Pennsylvania 19046
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Kissimmee, Florida 34759
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Knoxville, Tennessee 37920
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Lake Success, New York 11042
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Lake Worth, Florida 33449
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Madison, Wisconsin 53705
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Mount Arlington, New Jersey 07856
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Nashville, Tennessee 37203
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New York, New York 10021
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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...
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Norfolk, Virginia 23507
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Norwalk, Connecticut 06851
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Norwich, Connecticut 06360
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Oceanside, California 92056
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14860 Roscoe Boulevard
Panorama City, California 91402
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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...
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Port Royal, South Carolina 29935
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Raleigh, North Carolina 27609
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Richmond, Virginia 23226
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Riverside, California 92506
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2800 L Street
Sacramento, California 95816
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Salt Lake City, Utah 84107
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Santa Ana, California 92705
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Sebastopol, California 95472
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256 Bunn Drive
South Miami, Florida 33143
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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...
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Toms River, New Jersey 08757
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1060 East Foothill Boulevard
Upland, California 91786
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West Long Branch, New Jersey 07764
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Willow Grove, Pennsylvania 19090
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Winfield, Illinois 60190
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