Effect of LY2062430 on the Progression of Alzheimer's Disease - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00904683

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control 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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1000
Study Start Date:	May 2009
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
LY2062430: Experimental	Drug: LY2062430 400 mg intravenously (IV) every 4 weeks for 80 weeks
Placebo: Placebo Comparator	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

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

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 ( Chief Medical Officer )
ClinicalTrials.gov Identifier:	NCT00904683 History of Changes
Other Study ID Numbers:	11934, H8A-MC-LZAN
Study First Received:	May 18, 2009
Last Updated:	July 9, 2010
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 September 01, 2010