Trial record 5 of 9 for:    solanezumab

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: June 5, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Alzheimer's Disease
Drug: Solanezumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1275
Study Start Date: December 2010
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solanezumab Drug: Solanezumab
400 mg administered once every 4 weeks by intravenous infusion (IV) for 100 weeks
Other Name: LY2062430

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127633

  Show 148 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 and Company
ClinicalTrials.gov Identifier: NCT01127633     History of Changes
Other Study ID Numbers: 11935, H8A-MC-LZAO
Study First Received: May 19, 2010
Last Updated: June 5, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
European Union: European Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Haute Autorité de Santé Transparency Commission
France: Institutional Ethical Committee
France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Japan: Institutional Review Board
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Korea: Institutional Review Board
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Institutional Review Board
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Sweden: Swedish National Council on Medical Ethics
Taiwan: Center for Drug Evaluation
Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

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 July 22, 2014