Continued Safety Monitoring of Solanezumab in Alzheimer's Disease - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by (Responsible Party):	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01127633

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 or H8A-MC-LZAN.

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:

MedlinePlus related topics: Alzheimer's Disease Dementia

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1275
Study Start Date:	December 2010
Estimated Study Completion Date:	July 2014
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

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

Contacts

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

1-317-615-4559

Show 149 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:	May 18, 2012
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 - French Health Products Safety Agency 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 and Social Development 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 May 23, 2012