Alzheimer's Disease Clinical Trial
— EXPEDITION2Official title:
Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo
| Verified date | December 2012 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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) 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.
| Status | Completed |
| Enrollment | 1040 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 55 Years and older |
| Eligibility |
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 randomization 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | 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. | Bankstown | New South Wales |
| Australia | 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. | Box Hill | Victoria |
| Australia | 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. | Chermside | Queensland |
| Australia | 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. | Darlinghurst | New South Wales |
| Australia | 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. | Glen Iris | Victoria |
| Australia | 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. | Gosford | New South Wales |
| Australia | 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. | Heidelberg Heights | Victoria |
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| Korea, Republic of | 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. | Incheon | |
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| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Australia, France, Germany, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Spain, Sweden, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14) | Baseline, Week 80 | No | |
| Secondary | Change from Baseline to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score | Baseline, Week 80 | No | |
| Secondary | Change from Baseline to Week 80 in Neuropsychiatric Inventory (NPI) Score | Baseline, Week 80 | No | |
| Secondary | Change from Baseline to Week 80 in volumetric Magnetic Resonance Imaging (vMRI) | Baseline, Week 80 | No | |
| Secondary | Change from Baseline to Week 80 in Mini-Mental State Examination (MMSE) Score | Baseline, Week 80 | No | |
| Secondary | Change from Baseline to Week 80 in Resource Utilization in Dementia - Lite (RUD-Lite) Score | Baseline, Week 80 | No | |
| Secondary | Change from Baseline to Week 80 in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy) Score | Baseline, Week 80 | No | |
| Secondary | Change from Baseline to Week 80 in Quality of Life in Alzheimer's Disease (QoL-AD) Score | Baseline, Week 80 | No | |
| Secondary | Change from Baseline to Week 80 in Plasma Amyloid Beta Levels | Baseline, Week 80 | No | |
| Secondary | Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item and 12-Item Scale (ADAS-Cog11 and ADAS-Cog12) | Baseline, Week 80 | No | |
| Secondary | Change from Baseline to Week 80 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Score | Baseline, Week 80 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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