Status:
COMPLETED
A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE3
Brief Summary
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 pharmacokineti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2020
Estimated Enrollment :
799 Patients enrolled
Trial Details
Trial ID
NCT01224106
Start Date
November 30 2010
End Date
September 10 2020
Last Update
December 13 2021
Active Locations (139)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
2
University of California, San Diego
La Jolla, California, United States, 92037
3
Yale University ADRU
New Haven, Connecticut, United States, 06510
4
Brain Matters Research, Inc.
Delray Beach, Florida, United States, 33445