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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.
Age
50 - 85 years
Sex
ALL
Healthy Volunteers
No
Banner Alzheimer's Institute
Phoenix, Arizona, United States
University of California, San Diego
La Jolla, California, United States
Yale University ADRU
New Haven, Connecticut, United States
Brain Matters Research, Inc.
Delray Beach, Florida, United States
Infinity Clinical Research
Hollywood, Florida, United States
Accelerated Enrollment Solutions
Orlando, Florida, United States
Roskamp Institute, Inc.
Sarasota, Florida, United States
Compass Research
The Villages, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Start Date
November 30, 2010
Primary Completion Date
September 10, 2020
Completion Date
September 10, 2020
Last Updated
December 13, 2021
799
ACTUAL participants
Gantenerumab
DRUG
Placebo
DRUG
Lead Sponsor
Hoffmann-La Roche
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07033494