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Trial record 1 of 1 for:    01900665
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Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo (EXPEDITION 3)

This study has been terminated.
(Solanezumab did not meet the study's primary endpoint.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01900665
First Posted: July 16, 2013
Last Update Posted: March 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
To test the idea that solanezumab will slow the cognitive 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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Change from Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Functional Activities Questionnaire (FAQ) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, Week 80 ]
  • Proportion of Cognitive and Functional Responders [ Time Frame: Baseline through Week 80 ]
  • Change from Baseline in Plasma Amyloid-Beta (Aβ) Species [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, Week 80 ]
  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430) [ Time Frame: Baseline through Week 80 ]
  • Change from Baseline in Florbetapir Positron Emission Tomography (PET) Scan [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Cerebrospinal Fluid (CSF) Aβ Levels [ Time Frame: Baseline, Week 80 ]

Enrollment: 2121
Study Start Date: July 2013
Study Completion Date: February 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solanezumab
Solanezumab 400 milligrams (mg) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
Drug: Solanezumab
Administered Intravenously (IV)
Other Names:
  • LY2062430
  • A Beta Antibody
Placebo Comparator: Placebo
Placebo every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
Drug: Placebo
Administered IV

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900665


  Show 198 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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01900665     History of Changes
Other Study ID Numbers: 15136
H8A-MC-LZAX ( Other Identifier: Eli Lilly and Company )
First Submitted: July 12, 2013
First Posted: July 16, 2013
Last Update Posted: March 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders