Trial record 1 of 1 for:
EXPEDITION-EXT
Continued Safety Monitoring of Solanezumab in Alzheimer's Disease (EXPEDITION EXT)
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01127633
First received: May 19, 2010
Last updated: December 11, 2012
Last verified: December 2012
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Purpose
This study is an open-label extension study in Alzheimer's patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00905683).
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: Solanezumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Assess the Number of Participants with One or More Drug-Related Adverse Events (AEs) or any Serious AEs (SAEs) [ Time Frame: Baseline through Week 104 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline to 104-week endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
- Change from baseline to 104-week endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
- Change from baseline to 104-week endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
- Change from baseline to 104-week endpoint in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
- Change from baseline to 104-week endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
- Change from baseline to 104-week endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy version (EQ-5D Proxy) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
- Change from baseline to 104-week endpoint in Quality of Life in Alzheimer's Disease (QoL-AD) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
- Change from baseline to 104-week endpoint in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
- Change from baseline to 52-week endpoint in Plasma Amyloid Beta Levels [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
- Change from baseline to 104-week endpoint in volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
- Change from baseline to 104-week endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
- Change from baseline to 80-week endpoint in Amyloid Plaque Burden in the Brain using Positron Emission Tomography (PET) Imaging [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1275 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Solanezumab |
Drug: Solanezumab
400 mg administered once every 4 weeks by intravenous infusion (IV) for 100 weeks
Other Name: LY2062430
|
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
- Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks
- Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study
- Must have good vein access to administer infusions
- Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO
Exclusion Criteria:
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127633
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| United States, Washington | |
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| Seattle, Washington, United States, 98108 | |
| Argentina | |
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| Ciudad Automona De Buenos Aire, Argentina, C1111AAL | |
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| Cordoba, Argentina, X5004AOA | |
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| Mendoza, Argentina, 5500 | |
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| Rosario, Argentina, S2000BZL | |
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| Santa Fe, Argentina, S3000FWO | |
| Australia, New South Wales | |
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| Gosford, New South Wales, Australia, 2250 | |
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| Kogarah, New South Wales, Australia, 2217 | |
| Australia, Queensland | |
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| Chermside, Queensland, Australia, 4032 | |
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| Toowoomba, Queensland, Australia, 4650 | |
| Australia, Victoria | |
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| Box Hill, Victoria, Australia, 3128 | |
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| Glen Iris, Victoria, Australia, 3146 | |
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| Heidelberg Heights, Victoria, Australia, 3081 | |
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| Melbourne, Victoria, Australia, 3004 | |
| Australia, Western Australia | |
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| Subiaco, Western Australia, Australia, 6008 | |
| Brazil | |
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| Curitiba, Brazil, 80060-900 | |
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| Itapira, Brazil, 13970-905 | |
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| Porto Alegre, Brazil, 90110-270 | |
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| Rio De Janeiro, Brazil, 22271-100 | |
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| São Paulo, Brazil, 04024-002 | |
| Canada, Alberta | |
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| Medicine Hat, Alberta, Canada, T1B4E7 | |
| Canada, British Columbia | |
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| Kelowna, British Columbia, Canada, V1Y3G5 | |
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| Penticton, British Columbia, Canada, V2A 5C8 | |
| Canada, Ontario | |
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| Ottawa, Ontario, Canada, K1N 5C8 | |
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| Toronto, Ontario, Canada, M6M 3Z5 | |
| Canada, Quebec | |
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| Greenfield Park, Quebec, Canada, J4V 2J2 | |
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| Sherbrooke, Quebec, Canada, J1H1Z1 | |
| France | |
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| Paris, France, 75475 | |
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| Rennes, France, 35000 | |
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| Strasbourg, France, 67091 | |
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| Toulouse, France, 31300 | |
| Germany | |
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| Berlin, Germany, 12203 | |
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| Hamburg, Germany, 22307 | |
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| Hannover, Germany, 30559 | |
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| Mannheim, Germany, 68165 | |
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| Munich, Germany, D-81675 | |
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| Regensburg, Germany, 93042 | |
| Italy | |
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| Biella, Italy, 13900 | |
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| Boggiovara, Italy, 41100 | |
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| Chieti, Italy, 66013 | |
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| Genova, Italy, 16128 | |
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| Lido Di Camaiore, Italy, 55043 | |
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| Milano, Italy, 20132 | |
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| Rome, Italy, 00186 | |
| Japan | |
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| Aichi, Japan, 474-8511 | |
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| Ehime, Japan, 791-0295 | |
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| Fukuoka, Japan, 816-0864 | |
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| Hiroshima, Japan, 720-0825 | |
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| Hyogo, Japan, 514-8507 | |
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| Kanagawa, Japan, 247-8533 | |
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| Kyoto, Japan, 607-8062 | |
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| Osaka, Japan, 545-8586 | |
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| Shizuoka, Japan, 424-0911 | |
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| Tokyo, Japan, 187-8551 | |
| Korea, Republic of | |
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| Incheon, Korea, Republic of, 400-711 | |
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| Seongnam-Si, Korea, Republic of, 463-707 | |
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| Seoul, Korea, Republic of, 143-729 | |
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| Suwon-Si, Korea, Republic of, 443-721 | |
| Poland | |
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| Bydgoszcz, Poland, 85-796 | |
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| Gliwice, Poland, 44-100 | |
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| Katowice, Poland, 40-588 | |
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| Krakow, Poland, 31-530 | |
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| Lublin, Poland, 20-954 | |
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| Warsaw, Poland, 01-211 | |
| Russian Federation | |
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| Chelyabinsk, Russian Federation, 454091 | |
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| Saint Petersburg, Russian Federation, 190021 | |
| Spain | |
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| Barcelona, Spain, 08014 | |
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| Getafe, Spain, 28905 | |
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| Madrid, Spain, 28006 | |
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| Plasencia, Spain, 10600 | |
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| Terrassa, Spain, 08221 | |
| Sweden | |
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| Joenkoeping, Sweden, 551 85 | |
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| Kalmar, Sweden, 39185 | |
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| Lund, Sweden, 22241 | |
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| Molndal, Sweden, 43135 | |
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| Umea, Sweden, 901 85 | |
| Taiwan | |
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| Kuei Shan Hsiang, Taiwan, 33305 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Niao Sung Hsiang, Taiwan, 833 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Taipei, Taiwan, 112 | |
| United Kingdom | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Uckfield, E Susx, United Kingdom, TN225AW | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Scotland, Glasgow, United Kingdom, G20 0XA | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| London, Greater London, United Kingdom, N195NX | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Camberwell, London, United Kingdom, SE5 8AF | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01127633 History of Changes |
| Other Study ID Numbers: | 11935, H8A-MC-LZAO |
| Study First Received: | May 19, 2010 |
| Last Updated: | December 11, 2012 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Argentina: Human Research Bioethics Committee Argentina: Ministry of Health Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee Brazil: Ethics Committee Brazil: Ministry of Health Brazil: National Committee of Ethics in Research Canada: Canadian Institutes of Health Research Canada: Ethics Review Committee Canada: Health Canada European Union: European Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé France: Direction Générale de la Santé France: French Data Protection Authority France: Haute Autorité de Santé Transparency Commission France: Institutional Ethical Committee France: National Consultative Ethics Committee for Health and Life Sciences Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices Italy: Ethics Committee Italy: Ministry of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Japan: Institutional Review Board Japan: Pharmaceuticals and Medical Devices Agency Korea: Food and Drug Administration Korea: Institutional Review Board Poland: Ethics Committee Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Poland: The Central Register of Clinical Trials Russia: Ethics Committee Russia: FSI Scientific Center of Expertise of Medical Application Russia: Ministry of Health of the Russian Federation Russia: Pharmacological Committee, Ministry of Health Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Comité Ético de Investigación Clínica Spain: Ethics Committee Spain: Ministry of Health Spain: Spanish Agency of Medicines Sweden: Institutional Review Board Sweden: Medical Products Agency Sweden: Regional Ethical Review Board Sweden: Swedish National Council on Medical Ethics Taiwan: Center for Drug Evaluation Taiwan: Department of Health Taiwan: Institutional Review Board Taiwan: National Bureau of Controlled Drugs United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Institute for Health Research United Kingdom: Research Ethics Committee United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
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 May 19, 2013