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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00904683
First received: May 18, 2009
Last updated: December 11, 2012
Last verified: December 2012

May 18, 2009
December 11, 2012
May 2009
June 2012   (final data collection date for primary outcome measure)
Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT00904683 on ClinicalTrials.gov Archive Site
  • Change from Baseline to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 80 in Neuropsychiatric Inventory (NPI) Score [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 80 in volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 80 in Mini-Mental State Examination (MMSE) Score [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 80 in Resource Utilization in Dementia - Lite (RUD-Lite) Score [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 80 in Quality of Life in Alzheimer's Disease (QoL-AD) Score [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 80 in Plasma Amyloid Beta Levels [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Effect of LY2062430 on the Progression of Alzheimer's Disease
Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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
  • Experimental: LY2062430
    Intervention: Drug: LY2062430
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Doody RS, Thomas RG, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, Raman R, Sun X, Aisen PS, Siemers E, Liu-Seifert H, Mohs R; Alzheimer's Disease Cooperative Study Steering Committee; Solanezumab Study Group. Phase 3 trials of solanezumab for mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):311-21. doi: 10.1056/NEJMoa1312889.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1040
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom
 
NCT00904683
11934, H8A-MC-LZAN
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
December 2012

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