A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease



Status:Active, not recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 85
Updated:1/25/2019
Start Date:November 30, 2010
End Date:August 28, 2020

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Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease With Option for up to an Additional Two Years of Treatment and an Open-Label Extension With Active Study Treatment

This multi-center, randomized, double-blind, placebo-controlled parallel-group study will
evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety
and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be
randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo.
Participants who consent to be part of the sub study will undergo positron emission
tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is
104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2,
followed by an open-label extension (Part 3) until July 2020.

The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a
low probability of meeting the primary outcome measure with the doses studied. The study has
converted to open-label to investigate higher gantenerumab doses.


Inclusion Criteria:

- Adult participants, 50-85 years of age

- Participants with prodromal Alzheimer's disease who are not receiving memantine or
cholinesterase inhibitors

- Has a study partner who in the investigator's judgement has frequent and sufficient
contact with the participant as to be able to provide accurate information as to the
participant's cognitive and functional abilities, who agrees to provide information at
clinic visits which require partner input for scale completion

- Has had sufficient education or work experience to exclude mental retardation

- Study partner has noticed a recent gradual decrease in participant's memory (over the
last 12 months), which the participant may or may not be aware of

- Screening Mini Mental State Exam (MMSE) score of 24 or above

Additional inclusion criteria for sub study:

- Able and willing to travel to PET imaging center and complete the planned scanning
sessions

- Past and planned exposure to ionizing radiation not exceeding safe and permissible
levels

Exclusion Criteria:

- Other prior or current neurologic or medical disorder which may currently or during
the course of the study impair cognition or psychiatric functioning

- A history of stroke

- A documented history of transient ischemic attack within the last 12 months

- History of schizophrenia, schizoaffective or bipolar disorder

- Currently meets criteria for major depression

- Within the last 2 years, unstable or clinical significant cardiovascular disease
(myocardial infarction, angina pectoris)

Additional exclusion criteria for sub study:

- Inclusion in a research and/or medical protocol involving PET ligands or other
radioactive agents within 12 months

- Present or planned participation in a research and/or medical protocol involving PET
ligands or radioactive agents other than study WN25203

- Have planned or are planning to have exposure to ionizing radiation that in
combination with the planned administration with study amyloid PET ligand would result
in a cumulative exposure that exceeds local recommended exposure limits
We found this trial at
31
sites
Hollywood, Florida 33021
2721
mi
from 98109
Hollywood, FL
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
1866
mi
from 98109
Indianapolis, IN
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3838 South 700 East
Salt Lake City, Utah 84106
801-269-8200
705
mi
from 98109
Salt Lake City, UT
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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...
2178
mi
from 98109
Atlanta, GA
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Austin, Texas 78757
1770
mi
from 98109
Austin, TX
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2372
mi
from 98109
Bennington, VT
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4190 Juan D. Peron
Buenos Aires, C1181
6917
mi
from 98109
Buenos Aires,
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Charlotte, North Carolina 28211
2281
mi
from 98109
Charlotte, NC
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Dallas, Texas 75214
1680
mi
from 98109
Dallas, TX
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Delray Beach, Florida 33445
2702
mi
from 98109
Delray Beach, FL
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East Providence, Rhode Island 02914
2487
mi
from 98109
East Providence, RI
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415 South 28th Avenue
Hattiesburg, Mississippi 39401
2066
mi
from 98109
Hattiesburg, MS
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Jenkintown, Pennsylvania 19046
2371
mi
from 98109
Jenkintown, PA
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1816
mi
from 98109
Kalamazoo, MI
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
1056
mi
from 98109
La Jolla, CA
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401 New Jersey 73
Marlton, New Jersey 08053
2385
mi
from 98109
Marlton, NJ
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333 Cedar Street
New Haven, Connecticut 06510
2432
mi
from 98109
New Haven, CT
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Newton, Massachusetts 02459
2479
mi
from 98109
Newton, MA
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Orangeburg, New York 10962
2393
mi
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Orangeburg, NY
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100 West Gore Street
Orlando, Florida 32806
2547
mi
from 98109
Orlando, FL
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1701 Solar Drive
Oxnard, California 93030
941
mi
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Oxnard, CA
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Phoenix, Arizona 85006
1115
mi
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Phoenix, AZ
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220 South River Street
Plains, Pennsylvania 18705
2298
mi
from 98109
Plains, PA
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148
mi
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Portland, OR
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Princeton, New Jersey 08540
2383
mi
from 98109
Princeton, NJ
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345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
2486
mi
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Providence, RI
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Raleigh, North Carolina 27607
2358
mi
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Raleigh, NC
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435 East Henrietta Road
Rochester, New York 14627
2162
mi
from 98109
Rochester, NY
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Sarasota, Florida 34243
2549
mi
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Sarasota, FL
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The Villages, Florida 32162
2502
mi
from 98109
The Villages, FL
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West Palm Beach, Florida 33407
2690
mi
from 98109
West Palm Beach, FL
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