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Trial record 2 of 11 for:    solanezumab

A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO)

This study has been terminated.
(Insufficient scientific evidence that solanezumab would likely demonstrate a meaningful benefit to patients with prodromal AD as defined by the study protocol.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02760602
First Posted: May 3, 2016
Last Update Posted: June 16, 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
The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (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: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease

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 Subscale (ADAS-Cog14) Score [ Time Frame: Baseline, 24 Months ]

Secondary Outcome Measures:
  • Change from Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL) [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline on the Mini Mental Status Examination (MMSE) [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline on the Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline on the Functional Activities Questionnaire (FAQ) [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline on the Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline on the Free and Cued Selective Reminding Test (FCSRT) [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite) [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D) [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD) [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline in Volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr) [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline in Neocortical Tau Deposits using 18F-AV-1451 PET [ Time Frame: Baseline, 24 Months ]

Enrollment: 26
Study Start Date: June 2016
Study Completion Date: May 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solanezumab
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
Drug: Solanezumab
Administered IV
Other Name: LY2062430
Experimental: Placebo
Placebo given IV once every 4 weeks for up to 2 years.
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 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or MCI due to AD per National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
  • Scores 17-28 on MoCA at screening.
  • Scores <27 on free recall cutoff score from the FCSRT (Picture version) at screening.
  • Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).
  • Scores >0 on the FAQ.
  • Has a florbetapir PET scan or CSF result at screening consistent with the presence of amyloid pathology.

Exclusion Criteria:

  • Has had MRI or computerized tomography (CT) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of AD.
  • Has known allergy to humanized monoclonal antibodies.
  • Has an ongoing clinically significant laboratory abnormality, as determined by the investigator.
  • Has screening MRI with results showing >4 amyloid related imaging abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E.
  • Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
  • Has received treatment with a stable dose of an achetylcholinesterase (AChEI) inhibitor or memantine for less than 2 months before randomization. (If a participant has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.)
  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): NCT02760602


  Show 193 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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02760602     History of Changes
Other Study ID Numbers: 16349
H8A-MC-LZBE ( Other Identifier: Eli Lilly and Company )
2016-000108-27 ( EudraCT Number )
First Submitted: May 2, 2016
First Posted: May 3, 2016
Last Update Posted: June 16, 2017
Last Verified: June 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.


Keywords provided by Eli Lilly and Company:
anti-amyloid
monoclonal antibody

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