A Study of Gantenerumab in Patients With Prodromal Alzheimer's Disease
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01224106
First received: October 14, 2010
Last updated: February 23, 2015
Last verified: February 2015
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Purpose
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 patients with prodromal Alzheimer's Disease. Patients will be randomized to receive subcutaneous injections of either gantenerumab or placebo. Patients 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, with an option for an additional 2 years of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: gantenerumab Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 an Additional Two Years of Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Change in the Clinical Dementia Rating scale Sum of Boxes (CDR-SOB), a global measure of cognition and functional ability [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Substudy: Change in brain amyloid over time assessed with Positron Emission Tomography [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in cognition assessed with the Alzheimer Disease Assessment Scale-Cognition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Change in functioning assessed with the Functional Activities Questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Safety (nature and incidence of adverse events) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Pharmacokinetics: gantenerumab levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 770 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: gantenerumab
225 mg subcutaneous doses every 4 weeks for 104 weeks
|
| Experimental: 2 |
Drug: gantenerumab
105 mg subcutaneous doses every 4 weeks for 104 weeks
|
| Placebo Comparator: 3 |
Drug: placebo
subcutaneous doses every 4 weeks for 104 weeks
|
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, 50-85 years of age
- Patients 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 subject as to be able to provide accurate information as to the patient'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 patient's memory (e.g. over the last 12 months), which the patient may or may not be aware of
- Screening MMSE score of 24 or above
Additional inclusion criteria for sub study:
- Able and willing to travel to Positron Emission Tomography 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 (e.g. 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224106
Show 157 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224106
Contacts
| Contact: Reference Study ID Number: WN25203 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global.rochegenentechtrials@roche.com |
Show 157 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided by Hoffmann-La Roche
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01224106 History of Changes |
| Other Study ID Numbers: | WN25203, 2010-019895-66 |
| Study First Received: | October 14, 2010 |
| Last Updated: | February 23, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Dementia Mental Disorders Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Antibodies, Monoclonal Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015