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

Primary Purpose

Alzheimer's Disease

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Solanezumab

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring anti-amyloid, monoclonal antibody

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

Xenoscience
Banner Alzheimer's Institute
St Josephs Hospital and Medical Center
Banner Sun Health Research Institute
Center for Neurosciences
Arizona Health Sciences Center
Parexel Early Phase Unit at Glendale
Pacific Neuroscience Medical Group
Desert Valley Research
Pacific Research Network Inc
Sharp Mesa Vista Hospital
California Pacific Medical Center
Apex Research Institute
Care Access Research LLC
California Neuroscience Research
Care Access Research
MCB Clinical Research Centers
Mile High Research Center
Yale University School of Medicine
New England Institute for Clinical Research
Christiana Care Research Institute
Brain Matters Research
Neuropsychiatric Research Center of Southwest Florida
Sunrise Clinical Research
Clinical Neuroscience Solutions Inc
Mount Sinai Medical Center
Miami Jewish Health Systems
Suncoast Clinical Research
Sensible Healthcare
Compass Research
Pensacola Research Consultants, Inc.
Quantum Laboratories
Roskamp Institute
Axiom Research
Premiere Research Institute at Palm Beach Neurology
Atlanta Center of Medical Research
United Osteoporosis Center
Christie Clinic, LLC
Alexian Brothers Medical Center
Central DuPage Hospital
Fort Wayne Neurological Center
Indiana University School of Medicine
Josephson Wallack Munshower Neurology
Cotton O'Neil Clinic
Heartland Research Associates
Baptist Health Medical Group
Lake Charles Clinical Trials
Maine Neurology
Sheppard Pratt Health System
Johns Hopkins University School of Medicine
PharmaSite Research Inc
Sheppard Pratt Health System
ActivMed Practices & Research, Inc
Donald S Marks
QUEST Research Institute
Hattiesburg Clinic
ClinVest
Clinical Research Professionals
Millenium Psychiatric Associates LLC
St Lukes Hospital
Las Vegas Medical Research
Healthy Perspectives Innovative Mental Health Services, PL
ActivMed Practices & Research, Inc
Memory Enhancement Center of America, Inc.
Pyramid Clinical Research
Princeton Medical Institute
The Cognitive and Research Center of NJ
Advanced Memory Research Institute of New Jersey
Bio Behavioral Health
Albany Medical College
Richmond Behavorial Associates
Alzheimer's Memory Center
Piedmont Medical Research
University of Cincinnati Medical Center
Neurology Diagnostics, Inc.
Insight Clinical Trials
Summit Research Network Inc
Center for Cognitive Health
Abington Neurological Associates
Lehigh Valley Hospital
Lehigh Center for Clinical Research
Clinical Trial Center, LLC, Psychiatry
Northeastern Pennsylvania Memory & Alzheimer's Center
Rhode Island Mood & Memory Research Institute
Butler Hospital
Metrolina Neurological Research Institute
Baylor AT&T Memory Center
Baylor AT&T Memory Center
FutureSearch Trials
Houston Methodist
University of Texas Health Services Center - Houston
Clinical Trials of Texas, Inc.
Univ of Texas Health Science Center at San Antonio
The Memory Clinic
Sentara Medical Group
National Clinical Research - Richmond
Evergreen Professional Plaza
Dean Foundation for Health Research and Education
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Santa Cruz Behavioral PSC
Cortex, PSC
University Of Puerto Rico
Instituto de Neurologia Dra. Ivonne Fraga
Latin Clinical Trial Center
SomniCare Sleep Institute
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Solanezumab

Placebo

Arm Description

Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.

Placebo given IV once every 4 weeks for up to 2 years.

Outcomes

Primary Outcome Measures

Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score

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.

Secondary Outcome Measures

Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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

Concentration of amino acid peptide known as Aβ 1-42 in plasma.

Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)

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)

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

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

Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.

Full Information

NCT ID

NCT02760602

First Posted

May 2, 2016

Last Updated

September 25, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02760602

Brief Title

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

Acronym

ExpeditionPRO

Official Title

A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Terminated

Why Stopped

Insufficient scientific evidence that solanezumab would likely demonstrate a meaningful benefit to participants with prodromal AD as defined by study protocol.

Study Start Date

June 2016 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

anti-amyloid, monoclonal antibody

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Solanezumab

Arm Type

Experimental

Arm Description

Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Placebo given IV once every 4 weeks for up to 2 years.

Intervention Type

Drug

Intervention Name(s)

Solanezumab

Other Intervention Name(s)

LY2062430

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered IV

Primary Outcome Measure Information:

Title

Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score

Description

Time Frame

Baseline, 24 Months

Secondary Outcome Measure Information:

Title

Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)

Description

Time Frame

Baseline, 24 Months

Title

Change From Baseline on the Mini Mental Status Examination (MMSE)

Description

Time Frame

Baseline, 24 Months

Title

Change From Baseline on the Montreal Cognitive Assessment (MoCA)

Description

Time Frame

Baseline, 24 Months

Title

Change From Baseline on the Functional Activities Questionnaire (FAQ)

Description

Time Frame

Baseline, 24 Months

Title

Change From Baseline on the Neuropsychiatric Inventory (NPI)

Description

Time Frame

Baseline, 24 Months

Title

Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)

Description

Time Frame

Baseline, 24 Months

Title

Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Description

RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.

Time Frame

Baseline, 24 Months

Title

Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)

Description

Time Frame

Baseline, 24 Months

Title

Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)

Description

Time Frame

Baseline, 24 Months

Title

Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)

Description

Time Frame

Baseline, 24 Months

Title

Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD)

Description

Time Frame

Baseline, 24 Months

Title

Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab

Description

Concentration of amino acid peptide known as Aβ 1-42 in plasma.

Time Frame

Baseline, 24 Months

Title

Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)

Description

MRI will be used to assess the effect of treatment on rate of whole brain volume.

Time Frame

Baseline, 24 Months

Title

Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)

Description

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.

Time Frame

Baseline, 24 Months

Title

Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins

Description

Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.

Time Frame

Baseline, 24 Months

Title

Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET

Description

Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.

Time Frame

Baseline, 24 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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 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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Xenoscience

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

Banner Alzheimer's Institute

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

St Josephs Hospital and Medical Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

Banner Sun Health Research Institute

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

Center for Neurosciences

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85718

Country

United States

Facility Name

Arizona Health Sciences Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Parexel Early Phase Unit at Glendale

City

Glendale

State/Province

California

ZIP/Postal Code

91206-4140

Country

United States

Facility Name

Pacific Neuroscience Medical Group

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

Desert Valley Research

City

Rancho Mirage

State/Province

California

ZIP/Postal Code

92270

Country

United States

Facility Name

Pacific Research Network Inc

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Sharp Mesa Vista Hospital

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

California Pacific Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94114

Country

United States

Facility Name

Apex Research Institute

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

Care Access Research LLC

City

Santa Clarita

State/Province

California

ZIP/Postal Code

91321

Country

United States

Facility Name

California Neuroscience Research

City

Sherman Oaks

State/Province

California

ZIP/Postal Code

91403

Country

United States

Facility Name

Care Access Research

City

Valencia

State/Province

California

ZIP/Postal Code

91355

Country

United States

Facility Name

MCB Clinical Research Centers

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80910

Country

United States

Facility Name

Mile High Research Center

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

New England Institute for Clinical Research

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Christiana Care Research Institute

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

Brain Matters Research

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33445

Country

United States

Facility Name

Neuropsychiatric Research Center of Southwest Florida

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

Sunrise Clinical Research

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Clinical Neuroscience Solutions Inc

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Mount Sinai Medical Center

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

Miami Jewish Health Systems

City

Miami

State/Province

Florida

ZIP/Postal Code

33137

Country

United States

Facility Name

Suncoast Clinical Research

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Sensible Healthcare

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761

Country

United States

Facility Name

Compass Research

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Pensacola Research Consultants, Inc.

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32502

Country

United States

Facility Name

Quantum Laboratories

City

Pompano Beach

State/Province

Florida

ZIP/Postal Code

33064

Country

United States

Facility Name

Roskamp Institute

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34243

Country

United States

Facility Name

Axiom Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Premiere Research Institute at Palm Beach Neurology

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Atlanta Center of Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

United Osteoporosis Center

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

Christie Clinic, LLC

City

Champaign

State/Province

Illinois

ZIP/Postal Code

61820

Country

United States

Facility Name

Alexian Brothers Medical Center

City

Elk Grove Village

State/Province

Illinois

ZIP/Postal Code

60007

Country

United States

Facility Name

Central DuPage Hospital

City

Winfield

State/Province

Illinois

ZIP/Postal Code

60190

Country

United States

Facility Name

Fort Wayne Neurological Center

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46804

Country

United States

Facility Name

Indiana University School of Medicine

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Josephson Wallack Munshower Neurology

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Cotton O'Neil Clinic

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Heartland Research Associates

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

Baptist Health Medical Group

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Lake Charles Clinical Trials

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70629

Country

United States

Facility Name

Maine Neurology

City

Scarborough

State/Province

Maine

ZIP/Postal Code

04074

Country

United States

Facility Name

Sheppard Pratt Health System

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Johns Hopkins University School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

PharmaSite Research Inc

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21208

Country

United States

Facility Name

Sheppard Pratt Health System

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21285

Country

United States

Facility Name

ActivMed Practices & Research, Inc

City

Methuen

State/Province

Massachusetts

ZIP/Postal Code

01844

Country

United States

Facility Name

Donald S Marks

City

Plymouth

State/Province

Massachusetts

ZIP/Postal Code

02360-4843

Country

United States

Facility Name

QUEST Research Institute

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334

Country

United States

Facility Name

Hattiesburg Clinic

City

Hattiesburg

State/Province

Mississippi

ZIP/Postal Code

39401

Country

United States

Facility Name

ClinVest

City

Bolivar

State/Province

Missouri

ZIP/Postal Code

65613

Country

United States

Facility Name

Clinical Research Professionals

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Millenium Psychiatric Associates LLC

City

Creve Coeur

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

St Lukes Hospital

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

Las Vegas Medical Research

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89113

Country

United States

Facility Name

Healthy Perspectives Innovative Mental Health Services, PL

City

Nashua

State/Province

New Hampshire

ZIP/Postal Code

03060

Country

United States

Facility Name

ActivMed Practices & Research, Inc

City

Portsmouth

State/Province

New Hampshire

ZIP/Postal Code

03801

Country

United States

Facility Name

Memory Enhancement Center of America, Inc.

City

Eatontown

State/Province

New Jersey

ZIP/Postal Code

07724

Country

United States

Facility Name

Pyramid Clinical Research

City

Monroe

State/Province

New Jersey

ZIP/Postal Code

08831

Country

United States

Facility Name

Princeton Medical Institute

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Facility Name

The Cognitive and Research Center of NJ

City

Springfield

State/Province

New Jersey

ZIP/Postal Code

07081

Country

United States

Facility Name

Advanced Memory Research Institute of New Jersey

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Bio Behavioral Health

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Albany Medical College

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Richmond Behavorial Associates

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

Alzheimer's Memory Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28270

Country

United States

Facility Name

Piedmont Medical Research

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

University of Cincinnati Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Neurology Diagnostics, Inc.

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45459

Country

United States

Facility Name

Insight Clinical Trials

City

Shaker Heights

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Summit Research Network Inc

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Center for Cognitive Health

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

Abington Neurological Associates

City

Abington

State/Province

Pennsylvania

ZIP/Postal Code

19090

Country

United States

Facility Name

Lehigh Valley Hospital

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Facility Name

Lehigh Center for Clinical Research

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18104

Country

United States

Facility Name

Clinical Trial Center, LLC, Psychiatry

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

Northeastern Pennsylvania Memory & Alzheimer's Center

City

Plains

State/Province

Pennsylvania

ZIP/Postal Code

18705

Country

United States

Facility Name

Rhode Island Mood & Memory Research Institute

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

Butler Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

Metrolina Neurological Research Institute

City

Indian Land

State/Province

South Carolina

ZIP/Postal Code

29707

Country

United States

Facility Name

Baylor AT&T Memory Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75219

Country

United States

Facility Name

Baylor AT&T Memory Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

FutureSearch Trials

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Houston Methodist

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

University of Texas Health Services Center - Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Facility Name

Clinical Trials of Texas, Inc.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Univ of Texas Health Science Center at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

The Memory Clinic

City

Bennington

State/Province

Vermont

ZIP/Postal Code

05201

Country

United States

Facility Name

Sentara Medical Group

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

Facility Name

National Clinical Research - Richmond

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Evergreen Professional Plaza

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98034

Country

United States

Facility Name

Dean Foundation for Health Research and Education

City

Middleton

State/Province

Wisconsin

ZIP/Postal Code

53562

Country

United States

Facility Name

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

City

Gatineau

ZIP/Postal Code

J8T 8J1

Country

Canada

Facility Name

City

Greenfield Park

ZIP/Postal Code

J4V 2J2

Country

Canada

Facility Name

City

Halifax

ZIP/Postal Code

B3S1M7

Country

Canada

Facility Name

City

Kentville

ZIP/Postal Code

B4N 4K9

Country

Canada

Facility Name

City

London

ZIP/Postal Code

N6C 0A7

Country

Canada

Facility Name

City

Ottawa

ZIP/Postal Code

KIN 5C8

Country

Canada

Facility Name

City

Peterborough

ZIP/Postal Code

K9H2P4

Country

Canada

Facility Name

City

Sherbrooke

ZIP/Postal Code

J1H1Z1

Country

Canada

Facility Name

City

Toronto

ZIP/Postal Code

M3B 2S7

Country

Canada

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

City

Oulu

ZIP/Postal Code

90100

Country

Finland

Facility Name

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

City

Turku

ZIP/Postal Code

20014

Country

Finland

Facility Name

City

Vaasa

ZIP/Postal Code

65130

Country

Finland

Facility Name

City

Amiens

ZIP/Postal Code

80054

Country

France

Facility Name

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

City

Bron

ZIP/Postal Code

69677

Country

France

Facility Name

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75651

Country

France

Facility Name

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

City

Chemnitz

ZIP/Postal Code

09131

Country

Germany

Facility Name

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

City

Monza

ZIP/Postal Code

20052

Country

Italy

Facility Name

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

City

Perugia

ZIP/Postal Code

06134

Country

Italy

Facility Name

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

City

Roma

ZIP/Postal Code

00153

Country

Italy

Facility Name

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

City

Roma

ZIP/Postal Code

00179

Country

Italy

Facility Name

City

Roma

ZIP/Postal Code

00189

Country

Italy

Facility Name

City

Bunkyo-ku

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

City

Bunkyo-ku

ZIP/Postal Code

113-8655

Country

Japan

Facility Name

City

Hachioji

ZIP/Postal Code

193-0998

Country

Japan

Facility Name

City

Hyogo

ZIP/Postal Code

673-0848

Country

Japan

Facility Name

City

Kamakura

ZIP/Postal Code

247-8533

Country

Japan

Facility Name

City

Kodaira-shi

ZIP/Postal Code

187-8551

Country

Japan

Facility Name

City

Koriyama

ZIP/Postal Code

963-8052

Country

Japan

Facility Name

City

Kyoto-shi

ZIP/Postal Code

607-8113

Country

Japan

Facility Name

City

Mitaka-shi

ZIP/Postal Code

181-0013

Country

Japan

Facility Name

City

Shinjuku-Ku

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

City

Shizuoka

ZIP/Postal Code

424-0911

Country

Japan

Facility Name

City

Takamatsu

ZIP/Postal Code

760-8557

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

113-0034

Country

Japan

Facility Name

City

Tsu-shi

ZIP/Postal Code

514-8507

Country

Japan

Facility Name

City

Białystok

ZIP/Postal Code

15-732

Country

Poland

Facility Name

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-093

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

30-856

Country

Poland

Facility Name

City

Sopot

ZIP/Postal Code

81-824

Country

Poland

Facility Name

City

Warszawa

ZIP/Postal Code

01-697

Country

Poland

Facility Name

Santa Cruz Behavioral PSC

City

Bayamón

ZIP/Postal Code

00961-6911

Country

Puerto Rico

Facility Name

Cortex, PSC

City

Las Piedras

ZIP/Postal Code

00771

Country

Puerto Rico

Facility Name

University Of Puerto Rico

City

Rio Piedras

ZIP/Postal Code

00936

Country

Puerto Rico

Facility Name

Instituto de Neurologia Dra. Ivonne Fraga

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

Latin Clinical Trial Center

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

SomniCare Sleep Institute

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

City

Barcelona

ZIP/Postal Code

08014

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

City

Castellon de la Plana

ZIP/Postal Code

12004

Country

Spain

Facility Name

City

Getafe

ZIP/Postal Code

28905

Country

Spain

Facility Name

City

Getxo

ZIP/Postal Code

48993

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

City

Plasencia

ZIP/Postal Code

10600

Country

Spain

Facility Name

City

Salt

ZIP/Postal Code

17190

Country

Spain

Facility Name

City

San Sebastian

ZIP/Postal Code

20009

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

City

Malmö

ZIP/Postal Code

20502

Country

Sweden

Facility Name

City

Mölndal

ZIP/Postal Code

43141

Country

Sweden

Facility Name

City

Stockholm

ZIP/Postal Code

113 61

Country

Sweden

Facility Name

City

Umeå

ZIP/Postal Code

90105

Country

Sweden

Facility Name

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

City

Gwei Shan Township

ZIP/Postal Code

333

Country

Taiwan

Facility Name

City

Jhonghe City

ZIP/Postal Code

235

Country

Taiwan

Facility Name

City

Kaohsiung

ZIP/Postal Code

80756

Country

Taiwan

Facility Name

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

City

Bath

ZIP/Postal Code

BA1 3NG

Country

United Kingdom

Facility Name

City

Chelsea

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

City

Guildford

ZIP/Postal Code

GU2 7YD

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

W1G 9RU

Country

United Kingdom

Facility Name

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

City

Scotland

ZIP/Postal Code

G20 0XA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Links:

URL

http://www.lillytrialguide.com/en-US/studies/mild-cognitive%20impairment/LZBE#?postal=

Description

Click here for more information about this study: A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease

Learn more about this trial

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

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