Safety and Efficacy 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:August 22, 2018
End Date:May 2, 2023
Contact:Reference Study ID Number: WN39658 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 [MCI])

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

- Demonstrated abnormal memory function

- MMSE score great 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
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Glendale, California 91204
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201 Dowman Dr
Atlanta, Georgia 30303
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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5323 Harry Hines Blvd
Dallas, Texas 75235
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Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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Sarasota, Florida 34232
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2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
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Allentown, Pennsylvania 18104
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Augusta, Georgia 30912
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1115 Ronald Reagan Parkway
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Bangor, Maine 04401
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10301 Hagen Ranch Road
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Brooklyn, New York 11229
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159 Pioneer Street
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4190 Juan D. Peron
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501 Billingsley Road
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1750 West Harrison Street
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Chicago, Illinois 60634
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8890 McGaw Road
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Fayetteville, Arkansas 72703
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8900 State Line Road
Leawood, Kansas 66206
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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11301 Wilshire Blvd
Los Angeles, California 90073
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333 Cedar St
New Haven, Connecticut 06504
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Newton, Massachusetts 02459
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
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