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
Show 148 Study Locations
Show 148 Study LocationsSponsors 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 23, 2013