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Completed

NCT Number: NCT00904683

Effect of LY2062430 on the Progression of Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2062430

Drug

400 mg intravenously (IV) every 4 weeks for 80 weeks

Other names: A Beta Antibody, Solanezumab (*USAN adopted name, INN pending)

Placebo

Drug

intravenously (IV) every 4 weeks for 80 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo

Acronym: EXPEDITION2

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 20, 2009
Registry last updated
Dec 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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