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Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease (EXPEDITION EXT)

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

Eligibility Criteria

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

Inclusion Criteria:

Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks
Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study
Must have good vein access to administer infusions
Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO

Exclusion Criteria:

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study

Sites / Locations

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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.
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.
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.
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.
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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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Solanezumab

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)

The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Secondary Outcome Measures

Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)

ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean was determined by mixed model repeated measures (MMRM) methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 Mini-Mental State Examination (MMSE) status (mild/moderate), concomitant acetylcholinesterase inhibitors (AChEI)/Memantine use at baseline (yes/no), baseline age and treatment*visit.

Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)

ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - 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. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)

The NPI is a questionnaire administered to caregivers that quantifies behavioral changes in dementia. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144. Lower scores indicated less severity and higher scores indicated a greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours

The RUD-Lite is a caregiver-completed assessment designed to assess the amount of formal and informal resources used by participants and the primary caregiver. It is completed by the caregiver and compiles data on the following resources: length of time the caregiver spends giving care, assisting participants with basic activities of daily living (BADL: eating dressing, grooming, bathing); assisting participants with instrumental activities of daily living (IADLs: shopping, cooking, housekeeping, laundry, transportation, taking medication, managing finances), and providing supervision. Scores range from 0 to 24 hours. Higher values indicate greater resource use. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)

EQ-5D (proxy version) is a generic, multidimensional, health-related, quality-of-life instrument assessing caregiver's impression of participants overall health state. Profile allows caregivers to rate participant's health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale: 1 (no problem), 2 (some problems), and 3 (major problems). These attribute combinations are converted into a weighted Health-State Index Score according to the United States (US) population-based algorithm. EQ-5D US Population-Based Index Scores range from -0.11 to 1.0. A score of 1.0 indicated perfect health. The Overall Health State Index Score is caregiver-reported using a visual analogue scale marked 0 (worst imaginable health) to 100 (best imaginable health state). LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)

The QoL-AD (Caregiver Total Score) is a disease-specific measure of quality of life for an Alzheimer's Disease (AD) population administered to the participant's primary caregiver, who answers on behalf of the participant. The assessment consists of 13 items covering physical health, energy, mood, living situations, memory, family, marriage, friends, chores, fun, money, self and life as a whole. The assessment is scored on a 4-point Likert scale with scores ranging from 1 (poor) to 4 (excellent). QoL-AD Total Score is defined as the sum of the 13 items with a scores range from 13 to 52. Higher scores denote a better quality of life. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)

The MMSE is an instrument used to assess a participant's cognitive function. The instrument is divided into 2 sections. The first section measures orientation, memory, and attention with scores ranging from 0 to 21 (lower scores indicate greater impairment). The second section tests the ability of the participant to name objects, follow verbal and written commands, write a sentence, and copy figures with scores ranging from 0 to 9 (lower scores indicate greater impairment). The range for MMSE Total Score is 0 to 30. Lower scores indicate more impairment. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels

Concentration of the peptide Aβ 1-40 and Aβ 1-42 in plasma measured by immunoassay. The immunoassays for plasma Aβ 1-40 and Aβ 1-42 peptides were modified to render them tolerant to the presence of Solanezumab which would otherwise interfere with non-modified assays. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)

The vMRI assessment of right and left hippocampal volume is reported. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)

The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease: orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer's Disease

Florbetapir PET imaging was used to test for change from baseline. The hypothesis that amyloid burden was reduced in participants between the treatment groups from the feeder studies was tested. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum and to subject-specific white matter.

Full Information

NCT ID

NCT01127633

First Posted

May 19, 2010

Last Updated

September 25, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01127633

Brief Title

Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease

Acronym

EXPEDITION EXT

Official Title

Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Terminated

Why Stopped

Solanezumab did not meet the primary endpoint in study H8A-MC-LZAX.

Study Start Date

December 2010 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

February 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

This study is an open-label extension study in Alzheimer's patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00904683).

6. Conditions and Keywords

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

Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1457 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Solanezumab

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Solanezumab

Other Intervention Name(s)

LY2062430

Intervention Description

400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.

Primary Outcome Measure Information:

Title

Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)

Description

Time Frame

Baseline through Week 104

Secondary Outcome Measure Information:

Title

Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)

Description

Time Frame

Baseline, Week 104

Title

Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)

Description

Time Frame

Baseline, Week 104

Title

Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)

Description

Time Frame

Baseline, Week 104

Title

Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)

Description

Time Frame

Baseline, Week 104

Title

Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours

Description

Time Frame

Baseline, Week 104

Title

Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)

Description

Time Frame

Baseline, Week 104

Title

Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)

Description

Time Frame

Baseline, Week 104

Title

Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)

Description

Time Frame

Baseline, Week 104

Title

Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)

Description

Time Frame

Baseline, Week 104

Title

Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)

Description

Time Frame

Baseline, Week 104

Title

Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer's Disease

Description

Time Frame

Baseline, Week 104

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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 Alzheimer's Disease Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study Must have good vein access to administer infusions Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO Exclusion Criteria: Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study

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

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

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

City

Sun City

State/Province

Arizona

ZIP/Postal Code

85351

Country

United States

Facility Name

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85718

Country

United States

Facility Name

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Facility Name

City

Carson

State/Province

California

ZIP/Postal Code

90746

Country

United States

Facility Name

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Facility Name

City

Lomita

State/Province

California

ZIP/Postal Code

90717

Country

United States

Facility Name

City

Los Angeles

State/Province

California

ZIP/Postal Code

90073

Country

United States

Facility Name

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

Facility Name

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

City

Denver

State/Province

Colorado

ZIP/Postal Code

80239

Country

United States

Facility Name

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

Country

United States

Facility Name

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06518

Country

United States

Facility Name

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

City

Norwalk

State/Province

Connecticut

ZIP/Postal Code

06851

Country

United States

Facility Name

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20057

Country

United States

Facility Name

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33431

Country

United States

Facility Name

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

City

Miami Springs

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

City

Miami

State/Province

Florida

ZIP/Postal Code

33137

Country

United States

Facility Name

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

Country

United States

Facility Name

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Facility Name

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30341

Country

United States

Facility Name

City

Canton

State/Province

Georgia

ZIP/Postal Code

30114

Country

United States

Facility Name

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21285

Country

United States

Facility Name

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

Facility Name

City

Traverse City

State/Province

Michigan

ZIP/Postal Code

49684

Country

United States

Facility Name

City

Creve Coeur

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

City

Albany

State/Province

New York

ZIP/Postal Code

12205

Country

United States

Facility Name

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11235

Country

United States

Facility Name

City

Latham

State/Province

New York

ZIP/Postal Code

12210

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

City

Beachwood

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43623

Country

United States

Facility Name

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84108

Country

United States

Facility Name

City

Bennington

State/Province

Vermont

ZIP/Postal Code

05201

Country

United States

Facility Name

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Facility Name

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24018

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98108

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

CBA 1419

Country

Argentina

Facility Name

City

Ciudad Automona De Buenos Aire

ZIP/Postal Code

C1111AAL

Country

Argentina

Facility Name

City

Cordoba

ZIP/Postal Code

X5004AOA

Country

Argentina

Facility Name

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

S2000BZL

Country

Argentina

Facility Name

City

Santa Fe

ZIP/Postal Code

S3000FWO

Country

Argentina

Facility Name

City

Gosford

State/Province

New South Wales

ZIP/Postal Code

2250

Country

Australia

Facility Name

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

City

Chermside

State/Province

Queensland

ZIP/Postal Code

4032

Country

Australia

Facility Name

City

Toowoomba

State/Province

Queensland

ZIP/Postal Code

4650

Country

Australia

Facility Name

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

City

Glen Iris

State/Province

Victoria

ZIP/Postal Code

3146

Country

Australia

Facility Name

City

Heidelberg Heights

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

City

Subiaco

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

City

Curitiba

ZIP/Postal Code

80060-900

Country

Brazil

Facility Name

City

Itapira

ZIP/Postal Code

13970-905

Country

Brazil

Facility Name

City

Porto Alegre

ZIP/Postal Code

90110-270

Country

Brazil

Facility Name

City

Rio De Janeiro

ZIP/Postal Code

22271-100

Country

Brazil

Facility Name

City

São Paulo

ZIP/Postal Code

04024-002

Country

Brazil

Facility Name

City

Medicine Hat

State/Province

Alberta

ZIP/Postal Code

T1B4E7

Country

Canada

Facility Name

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y3G5

Country

Canada

Facility Name

City

Penticton

State/Province

British Columbia

ZIP/Postal Code

V2A 5C8

Country

Canada

Facility Name

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1N 5C8

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6M 3Z5

Country

Canada

Facility Name

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2J2

Country

Canada

Facility Name

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H1Z1

Country

Canada

Facility Name

City

Paris

ZIP/Postal Code

75475

Country

France

Facility Name

City

Rennes

ZIP/Postal Code

35000

Country

France

Facility Name

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

City

Toulouse

ZIP/Postal Code

31300

Country

France

Facility Name

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

22307

Country

Germany

Facility Name

City

Hannover

ZIP/Postal Code

30559

Country

Germany

Facility Name

City

Mannheim

ZIP/Postal Code

68165

Country

Germany

Facility Name

City

Munich

ZIP/Postal Code

D-81675

Country

Germany

Facility Name

City

Regensburg

ZIP/Postal Code

93042

Country

Germany

Facility Name

City

Baggiovara

ZIP/Postal Code

41100

Country

Italy

Facility Name

City

Biella

ZIP/Postal Code

13900

Country

Italy

Facility Name

City

Chieti

ZIP/Postal Code

66013

Country

Italy

Facility Name

City

Genova

ZIP/Postal Code

16128

Country

Italy

Facility Name

City

Lido Di Camaiore

ZIP/Postal Code

55043

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

City

Rome

ZIP/Postal Code

00186

Country

Italy

Facility Name

City

Aichi

ZIP/Postal Code

474-8511

Country

Japan

Facility Name

City

Ehime

ZIP/Postal Code

791-0295

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

816-0864

Country

Japan

Facility Name

City

Hiroshima

ZIP/Postal Code

720-0825

Country

Japan

Facility Name

City

Hyogo

ZIP/Postal Code

514-8507

Country

Japan

Facility Name

City

Kanagawa

ZIP/Postal Code

247-8533

Country

Japan

Facility Name

City

Kyoto

ZIP/Postal Code

607-8062

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

City

Shizuoka

ZIP/Postal Code

424-0911

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

187-8551

Country

Japan

Facility Name

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

City

Seongnam-Si

ZIP/Postal Code

463-707

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

143-729

Country

Korea, Republic of

Facility Name

City

Suwon-Si

ZIP/Postal Code

443-721

Country

Korea, Republic of

Facility Name

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Facility Name

City

Gliwice

ZIP/Postal Code

44-100

Country

Poland

Facility Name

City

Katowice

ZIP/Postal Code

40-588

Country

Poland

Facility Name

City

Krakow

ZIP/Postal Code

31-530

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-954

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

01-211

Country

Poland

Facility Name

City

Chelyabinsk

ZIP/Postal Code

454091

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

190021

Country

Russian Federation

Facility Name

City

Barcelona

ZIP/Postal Code

08014

Country

Spain

Facility Name

City

Getafe

ZIP/Postal Code

28905

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

Terrassa

ZIP/Postal Code

08221

Country

Spain

Facility Name

City

Jönköping

ZIP/Postal Code

551 85

Country

Sweden

Facility Name

City

Kalmar

ZIP/Postal Code

39185

Country

Sweden

Facility Name

City

Lund

ZIP/Postal Code

22241

Country

Sweden

Facility Name

City

Molndal

ZIP/Postal Code

43135

Country

Sweden

Facility Name

City

Umea

ZIP/Postal Code

901 85

Country

Sweden

Facility Name

City

Guishan

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

City

Niaosong

ZIP/Postal Code

833

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

City

Uckfield

State/Province

E Susx

ZIP/Postal Code

TN225AW

Country

United Kingdom

Facility Name

City

Scotland

State/Province

Glasgow

ZIP/Postal Code

G20 0XA

Country

United Kingdom

Facility Name

City

London

State/Province

Greater London

ZIP/Postal Code

N195NX

Country

United Kingdom

Facility Name

City

Camberwell

State/Province

London

ZIP/Postal Code

SE5 8AF

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/

Learn more about this trial

Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease

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