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

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ClinicalTrials.gov Identifier: NCT02760602
Recruitment Status : Terminated (Insufficient scientific evidence that solanezumab would likely demonstrate a meaningful benefit to participants with prodromal AD as defined by study protocol.)
First Posted : May 3, 2016
Results First Posted : July 24, 2018
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 2, 2016
First Posted Date  ICMJE May 3, 2016
Results First Submitted Date  ICMJE May 8, 2018
Results First Posted Date  ICMJE July 24, 2018
Last Update Posted Date October 10, 2019
Study Start Date  ICMJE June 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2018)
Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score [ Time Frame: Baseline, 24 Months ]
ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score [ Time Frame: Baseline, 24 Months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2018)
  • 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 ]
    The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs. Total score ranges from 0 to 69; lower score indicates greater disease severity.
  • Change From Baseline on the Mini Mental Status Examination (MMSE) [ Time Frame: Baseline, 24 Months ]
    MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants.Total score ranges from 0 to 30; lower score indicates greater disease severity.
  • Change From Baseline on the Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline, 24 Months ]
    The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.
  • Change From Baseline on the Functional Activities Questionnaire (FAQ) [ Time Frame: Baseline, 24 Months ]
    FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). The maximum FAQ total score is 30, with higher scores indicating greater impairment.
  • Change From Baseline on the Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 24 Months ]
    The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity.
  • Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) [ Time Frame: Baseline, 24 Months ]
    CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
  • Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Baseline, 24 Months ]
    RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.
  • Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT) [ Time Frame: Baseline, 24 Months ]
    The FCSRT is a neuropsychological test of memory under conditions that control attention and cognitive processing in order to obtain an assessment of memory unconfounded by normal age-related changes in cognition.
  • Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite) [ Time Frame: Baseline, 24 Months ]
    RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews.
  • Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D) [ Time Frame: Baseline, 24 Months ]
    EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Visual analogue scale (VAS) assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity.
  • Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD) [ Time Frame: Baseline, 24 Months ]
    QoL for AD assess participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL.
  • Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab [ Time Frame: Baseline, 24 Months ]
    Concentration of amino acid peptide known as Aβ 1-42 in plasma.
  • Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, 24 Months ]
    MRI will be used to assess the effect of treatment on rate of whole brain volume.
  • Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr) [ Time Frame: Baseline, 24 Months ]
    Florbetapir F18 PET used to assess the treatment effect in brain amyloid plaque deposition from baseline through 18 months as measured by florbetapir F18 PET Standardized Uptake Uptake Value ratio.
  • Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins [ Time Frame: Baseline, 24 Months ]
    Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.
  • Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET [ Time Frame: Baseline, 24 Months ]
    Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease
Official Title  ICMJE A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: Solanezumab
    Administered IV
    Other Name: LY2062430
  • Drug: Placebo
    Administered IV
Study Arms  ICMJE
  • Experimental: Solanezumab
    Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
    Intervention: Drug: Solanezumab
  • Experimental: Placebo
    Placebo given IV once every 4 weeks for up to 2 years.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 15, 2017)
26
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2016)
2450
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 mild cognitive impairment (MCI) due to AD per National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
  • Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening.
  • Scores <27 on free recall cutoff score from the Free and Cued Selective Reminding Test (FCSRT) (Picture version) at screening.
  • Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).
  • Scores >0 on the Functional Activities Questionnaire (FAQ).
  • Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (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 acetylcholinesterase (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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Finland,   France,   Germany,   Italy,   Japan,   Poland,   Puerto Rico,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Australia,   Belgium,   Korea, Republic of,   Netherlands,   Switzerland
 
Administrative Information
NCT Number  ICMJE NCT02760602
Other Study ID Numbers  ICMJE 16349
H8A-MC-LZBE ( Other Identifier: Eli Lilly and Company )
2016-000108-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP