Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatment solanezumab
Phase phase 3
Sponsor Eli Lilly and Company
Start date December 2010
End date July 2014
Trial size 1275 participants
Trial identifier NCT01127633, 11935, H8A-MC-LZAO

Summary

This study is an open-label extension study in Alzheimer's patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00904683).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
solanezumab LY2062430
400 mg administered once every 4 weeks by intravenous infusion (IV) for 100 weeks

Primary Outcomes

Measure
Assess the Number of Participants with One or More Drug-Related Adverse Events (AEs) or any Serious AEs (SAEs)
time frame: Baseline through Week 104

Secondary Outcomes

Measure
Change from baseline to 104-week endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)
time frame: Baseline, Week 104
Change from baseline to 104-week endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
time frame: Baseline, Week 104
Change from baseline to 104-week endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
time frame: Baseline, Week 104
Change from baseline to 104-week endpoint in Neuropsychiatric Inventory (NPI)
time frame: Baseline, Week 104
Change from baseline to 104-week endpoint in Resource Utilization in Dementia - Lite (RUD-Lite)
time frame: Baseline, Week 104
Change from baseline to 104-week endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy version (EQ-5D Proxy)
time frame: Baseline, Week 104
Change from baseline to 104-week endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
time frame: Baseline, Week 104
Change from baseline to 104-week endpoint in Mini-Mental State Examination (MMSE)
time frame: Baseline, Week 104
Change from baseline to 52-week endpoint in Plasma Amyloid Beta Levels
time frame: Baseline, Week 52
Change from baseline to 104-week endpoint in volumetric Magnetic Resonance Imaging (vMRI)
time frame: Baseline, Week 104
Change from baseline to 104-week endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)
time frame: Baseline, Week 104
Change from baseline to 80-week endpoint in Amyloid Plaque Burden in the Brain using Positron Emission Tomography (PET) Imaging
time frame: Baseline, Week 80

Eligibility Criteria

Male or female participants at least 55 years old.

Inclusion Criteria: - Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease - Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks - Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study - Must have good vein access to administer infusions - Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO Exclusion Criteria: - Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study - Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study

Additional Information

Official title Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.