Trial record 2 of 12 for:    Alzheimer's | Open Studies | United States, Utah

Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo (EXPEDITION 3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01900665
First received: July 12, 2013
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

To test the idea that solanezumab will slow the cognitive and functional decline of Alzheimer's Disease (AD) as compared with placebo in participants with mild AD.


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

Study Type: Interventional
Study Design: Allocation: Randomized
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 Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Functional Activities Questionnaire (FAQ) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Proportion of Cognitive and Functional Responders [ Time Frame: Baseline through Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Plasma Amyloid-Beta (Aβ) Species [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430) [ Time Frame: Baseline through Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Florbetapir Positron Emission Tomography (PET) Scan [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]
  • Change from Baseline in Cerebrospinal Fluid (CSF) Aβ Levels [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2100
Study Start Date: July 2013
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solanezumab
Solanezumab 400 milligram (mg) every 4 weeks for 18 months.
Drug: Solanezumab
Administered Intravenously (IV)
Other Names:
  • LY2062430
  • A Beta Antibody
Placebo Comparator: Placebo
Placebo every 4 weeks for 18 months.
Drug: Placebo
Administered IV

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
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 AD
  • Has a Modified Hachinski Ischemia Scale score of less than or equal to 4
  • Has a Mini-Mental State Examination (MMSE) score of 20 through 26 at Screening visit
  • Has a Geriatric Depression Scale score of less than or equal to 6 (on the staff-administered short form)
  • Has had a magnetic resonance imaging (MRI) or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD
  • Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result consistent with the presence of amyloid pathology at screening

Exclusion Criteria:

  • Does not have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week), will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications
  • Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
  • Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of <2 years
  • Has had a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness
  • Has a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment
  • Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
  • Has received acetylcholinesterase inhibitor (AChEIs), memantine and/or other AD therapy for less than 4 months or has less than 2 months of stable therapy on these treatments
  • Has received medications that affect the central nervous system (CNS), except treatments for AD, for less than 4 weeks
  • Has a history of chronic alcohol or drug abuse/dependence within the past 5 years
  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: NCT01900665

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 212 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: NCT01900665     History of Changes
Other Study ID Numbers: 15136, H8A-MC-LZAX
Study First Received: July 12, 2013
Last Updated: October 10, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 22, 2014