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Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00904683
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : December 13, 2012
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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) 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.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: LY2062430 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1040 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo
Study Start Date : May 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LY2062430 Drug: LY2062430
400 mg intravenously (IV) every 4 weeks for 80 weeks
Other Names:
  • A Beta Antibody
  • Solanezumab (*USAN adopted name, INN pending)
Placebo Comparator: Placebo Drug: Placebo
intravenously (IV) every 4 weeks for 80 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14) [ Time Frame: Baseline, Week 80 ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, Week 80 ]
  2. Change from Baseline to Week 80 in Neuropsychiatric Inventory (NPI) Score [ Time Frame: Baseline, Week 80 ]
  3. Change from Baseline to Week 80 in volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, Week 80 ]
  4. Change from Baseline to Week 80 in Mini-Mental State Examination (MMSE) Score [ Time Frame: Baseline, Week 80 ]
  5. Change from Baseline to Week 80 in Resource Utilization in Dementia - Lite (RUD-Lite) Score [ Time Frame: Baseline, Week 80 ]
  6. Change from Baseline to Week 80 in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy) Score [ Time Frame: Baseline, Week 80 ]
  7. Change from Baseline to Week 80 in Quality of Life in Alzheimer's Disease (QoL-AD) Score [ Time Frame: Baseline, Week 80 ]
  8. Change from Baseline to Week 80 in Plasma Amyloid Beta Levels [ Time Frame: Baseline, Week 80 ]
  9. 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) [ Time Frame: Baseline, Week 80 ]
  10. Change from Baseline to Week 80 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Score [ Time Frame: Baseline, Week 80 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904683


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00904683    
Other Study ID Numbers: 11934
H8A-MC-LZAN ( Other Identifier: Eli Lilly and Company )
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders