A Study of Gantenerumab in Patients With Prodromal Alzheimer's Disease
This study is currently recruiting participants.
Verified May 2013 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: May 7, 2013
Last verified: May 2013
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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:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- To evaluate the effect on the 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:
- Effect on cognition assessed with the Alzheimer Disease Assessment Scale-Cognition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Effect on 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: 4 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: | September 2016 |
| Estimated Primary Completion Date: | September 2016 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224106
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Contacts
| Contact: Please reference Study ID Number: WN25203 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Hide Study LocationsLocations
| United States, Arizona | |
| Active, not recruiting | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Active, not recruiting | |
| La Jolla, California, United States, 92037 | |
| Recruiting | |
| Oxnard, California, United States, 93030 | |
| United States, Connecticut | |
| Recruiting | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| Active, not recruiting | |
| Delray Beach, Florida, United States, 33445 | |
| Active, not recruiting | |
| Leesburg, Florida, United States, 34748 | |
| Recruiting | |
| Orlando, Florida, United States, 32806 | |
| Active, not recruiting | |
| Pompano Beach, Florida, United States, 33060 | |
| Recruiting | |
| Sarasota, Florida, United States, 34243 | |
| Active, not recruiting | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Recruiting | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Indiana | |
| Completed | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Active, not recruiting | |
| Chestnut Hill, Massachusetts, United States, 02467 | |
| United States, Michigan | |
| Active, not recruiting | |
| Kalamazoo, Michigan, United States, 49048 | |
| United States, Mississippi | |
| Recruiting | |
| Hattiesburg, Mississippi, United States, 39401 | |
| United States, New Jersey | |
| Recruiting | |
| Marlton, New Jersey, United States, 08053 | |
| Active, not recruiting | |
| Princeton, New Jersey, United States, 08540 | |
| United States, New York | |
| Active, not recruiting | |
| Orangeburg, New York, United States, 10962 | |
| Active, not recruiting | |
| Rochester, New York, United States, 14620 | |
| United States, North Carolina | |
| Recruiting | |
| Charlotte, North Carolina, United States, 28211 | |
| Recruiting | |
| Raleigh, North Carolina, United States, 27607-6010 | |
| United States, Oregon | |
| Active, not recruiting | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Recruiting | |
| Jenkintown, Pennsylvania, United States, 19046 | |
| Active, not recruiting | |
| Plains, Pennsylvania, United States, 18705 | |
| United States, Rhode Island | |
| Active, not recruiting | |
| East Providence, Rhode Island, United States, 02915 | |
| Active, not recruiting | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Texas | |
| Active, not recruiting | |
| Austin, Texas, United States, 78757 | |
| Active, not recruiting | |
| Dallas, Texas, United States, 75214 | |
| United States, Utah | |
| Recruiting | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Vermont | |
| Active, not recruiting | |
| Bennington, Vermont, United States, 05201 | |
| Argentina | |
| Recruiting | |
| Buenos Aires, Argentina, (C1425BWO) | |
| Recruiting | |
| Buenos Aires, Argentina, C1431FWO | |
| Completed | |
| Buenos Aires, Argentina, C1425CDC | |
| Recruiting | |
| Buenos Aires, Argentina, C1181ACH | |
| Recruiting | |
| Caba, Argentina, C1428AQK | |
| Terminated | |
| Caba, Argentina, C1022AAO | |
| Active, not recruiting | |
| Ciudad Autonoma Bs As, Argentina, 1264 | |
| Not yet recruiting | |
| Córdoba, Argentina, X5004AOA | |
| Completed | |
| La Plata, Argentina, B1902AJU | |
| Australia | |
| Recruiting | |
| Adelaide, Australia, 5000 | |
| Active, not recruiting | |
| Heidelberg West, Australia, 3081 | |
| Active, not recruiting | |
| Hornsby, Australia, 2077 | |
| Active, not recruiting | |
| Nedlands, Australia, 6009 | |
| Recruiting | |
| Randwick, Australia, 2031 | |
| Active, not recruiting | |
| Woodville, Australia, 5011 | |
| Belgium | |
| Recruiting | |
| Edegem, Belgium, 2650 | |
| Recruiting | |
| Leuven, Belgium, 3000 | |
| Brazil | |
| Active, not recruiting | |
| Curitiba, Brazil, 80060-900 | |
| Active, not recruiting | |
| Porto Alegre, Brazil, 90035-003 | |
| Recruiting | |
| Porto Alegre, Brazil, 90100-270 | |
| Not yet recruiting | |
| Sao Paulo, Brazil, 05403-000 | |
| Completed | |
| Sao Paulo, Brazil, 05403-010 | |
| Recruiting | |
| Sao Paulo, Brazil, 04024-002 | |
| Canada, Nova Scotia | |
| Active, not recruiting | |
| Kentville, Nova Scotia, Canada, B4N 4K9 | |
| Canada, Ontario | |
| Active, not recruiting | |
| Peterborough, Ontario, Canada, K9H 2P4 | |
| Active, not recruiting | |
| Toronto, Ontario, Canada, M6M 3Z5 | |
| Active, not recruiting | |
| Toronto, Ontario, Canada, M3B 2S7 | |
| Canada, Quebec | |
| Active, not recruiting | |
| Greenfield Park, Quebec, Canada, J4V 2J2 | |
| Completed | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Completed | |
| Quebec City, Quebec, Canada, G1J 1Z4 | |
| Terminated | |
| Sherbrooke, Quebec, Canada, J1H1Z1 | |
| Chile | |
| Not yet recruiting | |
| Santiago, Chile, 7500710 | |
| Not yet recruiting | |
| Santiago, Chile, 7560356 | |
| Not yet recruiting | |
| Viña de Mar, Chile, 2520997 | |
| Czech Republic | |
| Active, not recruiting | |
| Brno, Czech Republic, 656 91 | |
| Recruiting | |
| Olomouc, Czech Republic, 77520 | |
| Recruiting | |
| Rychnov Nad Kneznou, Czech Republic, 516 01 | |
| Denmark | |
| Recruiting | |
| Aarhus N, Denmark, 8200 | |
| Active, not recruiting | |
| København Ø, Denmark, 2100 | |
| Finland | |
| Active, not recruiting | |
| Turku, Finland, 20520 | |
| France | |
| Active, not recruiting | |
| Bobigny, France, 93009 | |
| Recruiting | |
| Bordeaux, France, 33076 | |
| Active, not recruiting | |
| Bron, France, 69677 | |
| Not yet recruiting | |
| Caen, France, 14033 | |
| Active, not recruiting | |
| Lille, France, 59037 | |
| Not yet recruiting | |
| Paris, France, 75651 | |
| Recruiting | |
| Rouen, France, 76031 | |
| Recruiting | |
| St Herblain, France, 44800 | |
| Recruiting | |
| Strasbourg, France, 67091 | |
| Active, not recruiting | |
| Toulouse, France, 31052 | |
| Germany | |
| Not yet recruiting | |
| Berlin, Germany, 14050 | |
| Active, not recruiting | |
| Bonn, Germany, 53127 | |
| Not yet recruiting | |
| Chemnitz, Germany, 09111 | |
| Recruiting | |
| Frankfurt, Germany, 60528 | |
| Active, not recruiting | |
| Leipzig, Germany, 04107 | |
| Recruiting | |
| Mannheim, Germany, 68159 | |
| Recruiting | |
| Munich, Germany, 81675 | |
| Active, not recruiting | |
| München, Germany, 80331 | |
| Recruiting | |
| Nürnberg, Germany, 90402 | |
| Recruiting | |
| Rostock, Germany, 18147 | |
| Recruiting | |
| ULM, Germany, 89081 | |
| Israel | |
| Not yet recruiting | |
| Haifa, Israel, 31096 | |
| Not yet recruiting | |
| Ramat Gan, Israel, 52621 | |
| Italy | |
| Recruiting | |
| Brescia, Italy, 25100 | |
| Active, not recruiting | |
| Brescia, Italy, 25125 | |
| Active, not recruiting | |
| Castellanza, Italy, 21053 | |
| Recruiting | |
| Firenze, Italy, 50134 | |
| Active, not recruiting | |
| Milano, Italy, 20132 | |
| Recruiting | |
| Milano, Italy, 20122 | |
| Active, not recruiting | |
| Modena, Italy, 41126 | |
| Active, not recruiting | |
| Parma, Italy, 43126 | |
| Active, not recruiting | |
| Torrette - Ancona, Italy, 60100 | |
| Recruiting | |
| Verona, Italy, 37126 | |
| Korea, Republic of | |
| Recruiting | |
| Seongnam Gyeonggi, Korea, Republic of, 463-707 | |
| Recruiting | |
| Seoul, Korea, Republic of, 135-710 | |
| Recruiting | |
| Seoul, Korea, Republic of, 143-729 | |
| Recruiting | |
| Seoul, Korea, Republic of, 138-736 | |
| Not yet recruiting | |
| Seoul, Korea, Republic of, 137-807 | |
| Mexico | |
| Recruiting | |
| Culiacan, Mexico, 80020 | |
| Active, not recruiting | |
| Guadalajara, Mexico, 44610 | |
| Not yet recruiting | |
| Guadalajara, Mexico, 44620 | |
| Recruiting | |
| Mexico City, Mexico, 11000 | |
| Active, not recruiting | |
| Monterrey, Mexico, 64710 | |
| Recruiting | |
| Monterrey, Mexico, 64460 | |
| Recruiting | |
| Saltillo, Mexico, 25000 | |
| Netherlands | |
| Active, not recruiting | |
| 's Hertogenbosch, Netherlands, 5223 GZ | |
| Recruiting | |
| Amsterdam, Netherlands, 1007 MB | |
| Poland | |
| Recruiting | |
| Bialystok, Poland, 15-732 | |
| Terminated | |
| Bydgoszcz, Poland, 85-094 | |
| Active, not recruiting | |
| Bydgoszcz, Poland, 85-796 | |
| Active, not recruiting | |
| Pozna, Poland, 61-853 | |
| Recruiting | |
| Warszawa, Poland, 01-813 | |
| Recruiting | |
| Warszawa, Poland, 01-231 | |
| Portugal | |
| Recruiting | |
| Amadora, Portugal, 2720-276 | |
| Recruiting | |
| Lisboa, Portugal, 1649-035 | |
| Russian Federation | |
| Recruiting | |
| Ekaterinburg, Russian Federation, 620036 | |
| Active, not recruiting | |
| Kazan, Russian Federation, 420101 | |
| Recruiting | |
| Saint Petersburg, Russian Federation, 190103 | |
| Recruiting | |
| Saratov, Russian Federation, 410028 | |
| Active, not recruiting | |
| St. Petersburg, Russian Federation, 194044 | |
| Spain | |
| Active, not recruiting | |
| Barakaldo, Spain, 48903 | |
| Active, not recruiting | |
| Barcelona, Spain, 08003 | |
| Active, not recruiting | |
| Barcelona, Spain, 08025 | |
| Active, not recruiting | |
| Barcelona, Spain, 08036 | |
| Active, not recruiting | |
| Barcelona, Spain, 08014 | |
| Terminated | |
| Madrid, Spain, 28040 | |
| Active, not recruiting | |
| Madrid, Spain, 28046 | |
| Active, not recruiting | |
| Madrid, Spain, 28034 | |
| Active, not recruiting | |
| Madrid, Spain, 28041 | |
| Recruiting | |
| Terrasa, Spain, 08221 | |
| Active, not recruiting | |
| Valencia, Spain, 46017 | |
| Sweden | |
| Active, not recruiting | |
| Malmoe, Sweden, 20502 | |
| Switzerland | |
| Recruiting | |
| Basel, Switzerland, 4031 | |
| Recruiting | |
| Chêne-bourg, Switzerland, 1225 | |
| Turkey | |
| Recruiting | |
| Antalya, Turkey, 07058 | |
| Not yet recruiting | |
| Eskiehir, Turkey, 26480 | |
| Active, not recruiting | |
| Istanbul, Turkey, 34093 | |
| Active, not recruiting | |
| Samsun, Turkey, 55139 | |
| United Kingdom | |
| Recruiting | |
| Cambridge, United Kingdom, CB2 0QQ | |
| Recruiting | |
| Cardiff, United Kingdom, CF64 2XX | |
| Recruiting | |
| Epping, United Kingdom, CM16 6TN | |
| Recruiting | |
| Glasgow, United Kingdom, G20 0XA | |
| Active, not recruiting | |
| London, United Kingdom, W6 8RF | |
| Recruiting | |
| Newcastle, United Kingdom, NE4 5PL | |
| Terminated | |
| Oxford, United Kingdom, OX3 9DU | |
| Active, not recruiting | |
| Southampton, United Kingdom, SO30 3JB | |
| Active, not recruiting | |
| Swindon, United Kingdom, SN3 6BW | |
| Recruiting | |
| Warrington, United Kingdom, WA2 8WA | |
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: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013