Gantenerumab for Prodromal Alzheimer's Disease
Gantenerumab for Prodromal Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
This Phase III study will evaluate the safety and efficacy of the experimental drug gantenerumab on cognition and functioning in people with prodromal (very early stage) Alzheimer's disease. Participants will be randomized to receive subcutaneous (under the skin) injections of either gantenerumab or a placebo. Those who consent to be part of the substudy will undergo positron emission tomography (PET) scanning to assess brain amyloid levels. The anticipated treatment time is 2 years.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | 85 Years | Both | No |
Inclusion Criteria:
- People with prodromal (very early stage) Alzheimer's disease who are not taking memantine or cholinesterase inhibitors
- Study partner who has frequent, sufficient contact with the subject and can provide accurate information about his or her cognitive and functional abilities at clinic visits
- Study partner has noticed recent gradual decrease in person's memory, which the person may or may not be aware of
- Sufficient education or work experience to exclude mental retardation
- Mini Mental State Examination score of 24 or higher
- Able and willing to travel to PET imaging center and complete scanning sessions
- Past or planned exposure to ionizing radiation not exceeding safe and permissible levels
Additional inclusion criteria for substudy
Exclusion Criteria:
- Other prior or current neurologic or medical disorder that may impair cognition or psychiatric functioning
- History of stroke; transient ischemic attack within the last 12 months; schizophrenia, schizoaffective or bipolar disorder; current major depression
- Unstable or clinical significant cardiovascular disease within the past 2 years (for example, myocardial infarction, angina pectoris)
- Inclusion in research and/or medical protocol involving PET ligands or other radioactive agents within the past 12 months
- Present or planned participation in research and/or medical protocol involving PET ligands or radioactive agents other than gantenerumab
- Past or planned exposure to ionizing radiation that, in combination with the study amyloid PET ligand, would result in cumulative exposure that exceeds recommended exposure limits
Additional exclusion criteria for substudy
Detailed Description:
In this study, investigators will test two doses of gantenerumab and compare the drug's effects to those of a placebo. Gantenerumab is a humanized monoclonocal antibody designed to lower levels of the toxic protein beta-amyloid in the brain. It will be administered as a subcutaneous (under the skin) injection. Study time is 2 years, with an option for an additional 2 years of treatment.
Central Contact Information:
For more information about this study or study sites, please call 888-662-6728 (toll-free; U.S. only) or email genentechclinicaltrials@druginfo.com. Reference study number WN25203.
Locations:
| Map Marker | City | State | Zip Code | Status | |
|---|---|---|---|---|---|
Geolocation is 33.4636012, -112.0535987 | Site | Phoenix | Arizona | 85006 | Active, not recruiting |
Geolocation is 32.84722, -117.27333 | Site | La Jolla | California | 92037 | Active, not recruiting |
Geolocation is 34.2054029, -119.1681373 | Site | Oxnard | California | 93030 | Recruiting |
Geolocation is 41.3052226, -72.9268626 | Site | New Haven | Connecticut | 06510 | Recruiting |
Geolocation is 26.4647478, -80.109357 | Site | Delray Beach | Florida | 33445 | Active, not recruiting |
Geolocation is 28.810823, -81.8778582 | Site | Leesburg | Florida | 34748 | Active, not recruiting |
Geolocation is 28.5085825, -81.3564411 | Site | Orlando | Florida | 32806 | Recruiting |
Geolocation is 26.237305, -80.1149414 | Site | Pompano Beach | Florida | 33060 | Active, not recruiting |
Geolocation is 27.4081935, -82.5294065 | Site | Sarasota | Florida | 34243 | Recruiting |
Geolocation is 26.7619563, -80.1037721 | Site | West Palm Beach | Florida | 33407 | Active, not recruiting |
Geolocation is 33.7717008, -84.3726049 | Site | Atlanta | Georgia | 30308 | Recruiting |
Geolocation is 39.7794767, -86.1700894 | Site | Indianapolis | Indiana | 46202 | Completed |
Geolocation is 42.3303798, -71.166187 | Site | Chestnut Hill | Massachusetts | 02467 | Active, not recruiting |
Geolocation is 42.2917069, -85.5872286 | Site | Kalamazoo | Michigan | 49048 | Active, not recruiting |
Geolocation is 31.3271189, -89.2903392 | Site | Hattiesburg | Mississippi | 39401 | Recruiting |
Geolocation is 39.8912248, -74.9218324 | Site | Marlton | New Jersey | 08053 | Recruiting |
Geolocation is 40.3572976, -74.6672226 | Site | Princeton | New Jersey | 08540 | Active, not recruiting |
Geolocation is 41.0464858, -73.9495818 | Site | Orangeburg | New York | 10962 | Active, not recruiting |
Geolocation is 43.1301942, -77.6020569 | Site | Rochester | New York | 14620 | Active, not recruiting |
Geolocation is 35.1660032, -80.7934798 | Site | Charlotte | North Carolina | 28211 | Recruiting |
Geolocation is 35.8019142, -78.6875364 | Site | Raleigh | North Carolina | 27607-6010 | Recruiting |
Geolocation is 45.4874111, -122.6875541 | Site | Portland | Oregon | 97239 | Active, not recruiting |
Geolocation is 40.0959438, -75.1251743 | Site | Jenkintown | Pennsylvania | 19046 | Recruiting |
Geolocation is 41.2753589, -75.8501955 | Site | Plains | Pennsylvania | 18705 | Active, not recruiting |
Geolocation is 41.7798634, -71.3468091 | Site | East Providence | Rhode Island | 02915 | Active, not recruiting |
Geolocation is 41.8396817, -71.3883751 | Site | Providence | Rhode Island | 02906 | Active, not recruiting |
Geolocation is 30.3507705, -97.7362384 | Site | Austin | Texas | 78757 | Active, not recruiting |
Geolocation is 32.824251, -96.7440467 | Site | Dallas | Texas | 75214 | Active, not recruiting |
Geolocation is 40.7078639, -111.8508966 | Site | Salt Lake City | Utah | 84106 | Recruiting |
Geolocation is 42.878094, -73.1968001 | Site | Bennington | Vermont | 05201 | Active, not recruiting |
Geolocation is 45.0836805, -64.497142 | Site | Kentville | Nova Scotia | B4N 4K9 | Active, not recruiting |
Geolocation is 44.3073347, -78.3218108 | Site | Peterborough | Ontario | K9H 2P4 | Active, not recruiting |
Geolocation is 43.698592, -79.4751345 | Site | Toronto | Ontario | M6M 3Z5 | Active, not recruiting |
Geolocation is 43.7585342, -79.3535081 | Site | Toronto | Ontario | M3B 2S7 | Active, not recruiting |
Geolocation is 45.4808565, -73.4666522 | Site | Greenfield Park | Quebec | J4V 2J2 | Active, not recruiting |
Geolocation is 45.4976084, -73.6292768 | Site | Montreal | Quebec | H3T 1E2 | Completed |
Geolocation is 46.8371449, -71.226169 | Site | Quebec City | Quebec | G1J 1Z4 | Completed |
Geolocation is 45.3945049, -71.8975156 | Site | Sherbrooke | Quebec | J1H1Z1 | Terminated |
Lead Sponsor:
| Agency |
|---|
Hoffmann-La Roche |
Collaborator Sponsor:
| Agency |
|---|
None |
Facility Investigators:
| Role | Affiliation |
|---|---|
Study Director | Hoffmann-La Roche |
Study Contact:
| Name | Phone | |
|---|---|---|
Hoffman-LaRoche | 888-662-6728 (U.S. only) |
Locations
ClinicalTrials.gov ID
NCT01224106 (follow link to view full record on ct.gov in new window)
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
Study Start Date:
November 2010
Study End Date:
September 2016
Disease Stage:
Early
Enrollment:
770
