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

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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

Tracking Information
First Submitted Date  ICMJE May 18, 2009
First Posted Date  ICMJE May 20, 2009
Last Update Posted Date December 13, 2012
Study Start Date  ICMJE May 2009
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14) [ Time Frame: Baseline, Week 80 ]
Original 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 ]
  • Change from baseline to endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Baseline, 80 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • Change from Baseline to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline to Week 80 in Neuropsychiatric Inventory (NPI) Score [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline to Week 80 in volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline to Week 80 in Mini-Mental State Examination (MMSE) Score [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline to Week 80 in Resource Utilization in Dementia - Lite (RUD-Lite) Score [ Time Frame: Baseline, Week 80 ]
  • 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 ]
  • Change from Baseline to Week 80 in Quality of Life in Alzheimer's Disease (QoL-AD) Score [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline to Week 80 in Plasma Amyloid Beta Levels [ Time Frame: Baseline, Week 80 ]
  • 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 ]
  • 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 ]
Original 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 ]
  • Change from baseline to endpoint in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 80 weeks ]
  • Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI) [ Time Frame: Baseline, 80 weeks ]
  • Change from baseline to endpoint in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, 80 weeks ]
  • Change from baseline to endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) [ Time Frame: Baseline, 80 weeks ]
  • 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 ]
  • Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD) [ Time Frame: Baseline, 80 weeks ]
  • 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 ]
  • Change from baseline to endpoint in plasma A Beta [ Time Frame: Baseline, 80 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of LY2062430 on the Progression of Alzheimer's Disease
Official Title  ICMJE Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: LY2062430
    400 mg intravenously (IV) every 4 weeks for 80 weeks
    Other Names:
    • A Beta Antibody
    • Solanezumab (*USAN adopted name, INN pending)
  • Drug: Placebo
    intravenously (IV) every 4 weeks for 80 weeks
Study Arms  ICMJE
  • Experimental: LY2062430
    Intervention: Drug: LY2062430
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2012)
1040
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2009)
1000
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00904683
Other Study ID Numbers  ICMJE 11934
H8A-MC-LZAN ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
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
PRS Account Eli Lilly and Company
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP