Effect of LY2062430 on the Progression of Alzheimer's Disease

Phase 3

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
LY2062430	LY2062430	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline to Week 80 in Alzheimer's Disease Assessment Scale - Cognitive Subscore 14-Item Scale (ADAS-Cog14)	Baseline, Week 80

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to Week 80 in volumetric Magnetic Resonance Imaging (vMRI)	Baseline, Week 80
Change from Baseline to Week 80 in Resource Utilization in Dementia - Lite (RUD-Lite) Score	Baseline, Week 80
Change from Baseline to Week 80 in Quality of Life in Alzheimer's Disease (QoL-AD) Score	Baseline, Week 80
Change from Baseline to Week 80 in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	Baseline, Week 80
Change from Baseline to Week 80 in Mini-Mental State Examination (MMSE) Score	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	Baseline, Week 80
Change from Baseline to Week 80 in Plasma Amyloid Beta Levels	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)	Baseline, Week 80
Change from Baseline to Week 80 in Neuropsychiatric Inventory (NPI) Score	Baseline, Week 80
Change from Baseline to Week 80 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Score	Baseline, Week 80

Locations (1): 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.
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Swindon, Wiltshire, United Kingdom