Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION2)
Tracking Information| Start Date ICMJE | May 2009 |
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| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE
(submitted: May 18, 2009) | - Change from baseline to endpoint in Alzheimer's Disease Assessment Scale - Cognitive subscore (ADAS-Cog11) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
- Change from baseline to endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
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| Original Primary Outcome Measures ICMJE | Same as current |
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| Change History | Complete list of historical versions of study NCT00904683 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE
(submitted: May 18, 2009) | - Change from baseline to endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
- Change from baseline to endpoint in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
- Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
- Change from baseline to endpoint in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
- Change from baseline to endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
- Change from baseline to endpoint in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
- Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD) [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
- Change from baseline to endpoint in plasma LY2062430 to investigate a relationship between plasma LY2062430 and plasma A Beta levels [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
- Change from baseline to endpoint in plasma A Beta [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
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| Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive Information| Brief Title ICMJE | Effect of LY2062430 on the Progression of Alzheimer's Disease |
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| Official Title ICMJE | Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo |
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| Brief Summary | Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized by progressive decline in cognitive function and ability to perform activities of daily living, and ultimately can lead to death due to complications of the disease. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase clearance, might be expected to slow the progression of AD. LY2062430 (solanezumab *USAN adopted name, INN pending) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1) monoclonal antibody being developed for the treatment of AD. The primary hypothesis being tested is that LY2062430 will slow cognitive and functional decline in AD as compared with placebo. Each patient's participation will last approximately 19 months. Patients taking approved AD medications may participate in this study and continue taking these medications during the study. |
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| Detailed Description | |
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| Study Phase | Phase III |
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| Study Type ICMJE | Interventional |
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| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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| Condition ICMJE | Alzheimer's Disease |
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| Intervention ICMJE | |
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| Study Arms / Comparison Groups | |
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Recruitment Information| Estimated Enrollment ICMJE | 1000 |
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| Estimated Completion Date | July 2012 |
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| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) |
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| Eligibility Criteria ICMJE | Inclusion Criteria: - Meets criteria for mild to moderate Alzheimer's Disease (AD) with Mini-Mental State Examination score of 16 through 26 at screening
- Modified Hachinski Ischemia Scale score of less than or equal to 4
- Geriatric Depression Scale score of less than or equal to 6
- A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
- If receiving concurrent AD treatment, must be on the medication for at least 4 months at a stable dose for at least 2 months prior to entering the study
Exclusion Criteria: - Has serious or unstable illness(es)
- Does not have a reliable caregiver who is in frequent contact with patient (at least 10 hours per week)
- Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
- Does not have good venous access, such that intravenous (IV) drug delivery would be difficult
- Has had multiple episodes of head trauma or history within the last 5 years of a serious infectious disease affecting the brain
- Has allergies to humanized monoclonal antibodies
- Chronic alcohol and/or drug abuse within the past 5 years
- Has any contraindications for MRI studies
- Requires treatment with another monoclonal antibody
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| Gender | Both |
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| Ages | 55 Years and older |
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| Accepts Healthy Volunteers | No |
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| Contacts ICMJE | | Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | | |
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| Location Countries ICMJE | United States, Australia, France, Germany, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Spain, Sweden, Taiwan, United Kingdom |
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Administrative Information| NCT ID ICMJE | NCT00904683 |
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| Responsible Party | Chief Medical Officer, Eli Lilly |
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| Study ID Numbers ICMJE | 11934, H8A-MC-LZAN |
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| Study Sponsor ICMJE | Eli Lilly and Company |
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| Collaborators ICMJE | |
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| Investigators ICMJE | | 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 | |
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| Information Provided By | Eli Lilly and Company |
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