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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
History of Changes
  Purpose

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 Intervention Phase
Alzheimer's Disease
 Drug: LY2062430
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1040
Study Start Date: May 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904683

  Show 95 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00904683     History of Changes
Other Study ID Numbers: 11934, H8A-MC-LZAN
Study First Received: May 18, 2009
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013