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Continued Safety Monitoring of Solanezumab in Alzheimer's Disease (EXPEDITION EXT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01127633
First received: May 19, 2010
Last updated: December 11, 2012
Last verified: December 2012
History of Changes

May 19, 2010
December 11, 2012
December 2010
July 2014   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
  • Vital signs that are statistically different between treatment groups (LZAM and LZAN) [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
  • Laboratory values that are statistically different between treatment groups (LZAM and LZAN) [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiograms (ECGs) that are statistically different between treatment groups (LZAM and LZAN) [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01127633 on ClinicalTrials.gov Archive Site
  • Change from baseline to 104-week endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in Quality of Life in Alzheimer's Disease (QoL-AD) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 52-week endpoint in Plasma Amyloid Beta Levels [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline to 104 week endpoint in Alzheimer's Disease Assessment Scale—Cognitive subscore (ADAS-Cog) [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 104 week endpoint in Alzheimer's Disease Cooperative Study—Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 104 week endpoint in Clinical Dementia Rating—Sum of Boxes (CDR-SB) [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 104 week endpoint in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 104 week endpoint in Resource Utilization in Dementia—Lite (RUD-Lite) [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
  • 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, 104 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 104 week endpoint in Quality of Life in Alzheimer's Disease (QoL-AD) [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 104 week endpoint in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in plasma Aβ levels [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 104 week endpoint in volumetric magnetic resonance imaging (vMRI) [ Time Frame: Baseline, 104 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 80 week endpoint in amyloid plaque burden in the brain using positron emission tomography (PET) imaging [ Time Frame: Baseline, 80 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Continued Safety Monitoring of Solanezumab in Alzheimer's Disease
Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease

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 (NCT00905683).
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Drug: Solanezumab
400 mg administered once every 4 weeks by intravenous infusion (IV) for 100 weeks
Other Name: LY2062430
Experimental: Solanezumab
Intervention: Drug: Solanezumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1275
June 2016
July 2014   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Canada,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom
 
NCT01127633
11935, H8A-MC-LZAO
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP