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
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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...
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3838 South 700 East
Salt Lake City, Utah 84106
801-269-8200
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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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Austin, Texas 78757
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4190 Juan D. Peron
Buenos Aires, C1181
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Charlotte, North Carolina 28211
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Dallas, Texas 75214
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Delray Beach, Florida 33445
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East Providence, Rhode Island 02914
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415 South 28th Avenue
Hattiesburg, Mississippi 39401
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Hollywood, Florida 33021
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Jenkintown, Pennsylvania 19046
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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...
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401 New Jersey 73
Marlton, New Jersey 08053
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333 Cedar Street
New Haven, Connecticut 06510
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Newton, Massachusetts 02459
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Orangeburg, New York 10962
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100 West Gore Street
Orlando, Florida 32806
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1701 Solar Drive
Oxnard, California 93030
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220 South River Street
Plains, Pennsylvania 18705
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Princeton, New Jersey 08540
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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...
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Raleigh, North Carolina 27607
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435 East Henrietta Road
Rochester, New York 14627
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Sarasota, Florida 34243
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