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A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia (DAYBREAK-ALZ)

Primary Purpose

Alzheimer's Disease

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Lanabecestat

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring dementia, brain diseases, neurodegenerative diseases, central nervous system diseases, nervous system diseases, mental disorders, delirium, dementia, amnestic, cognitive, tauopathies, memory, amyloid

Eligibility Criteria

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

Inclusion Criteria:

Participant must meet the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (NIA-AA) criteria for probable AD dementia.
MMSE score of 20 to 26 inclusive at screening visit.
For a diagnosis of mild AD dementia, participant must have a CDR global score of 0.5 or 1, with the memory box score ≥0.5 at screening.
Evidence of amyloid pathology.
The participant must have a reliable study partner with whom he/she cohabits or has regular contact.

Exclusion Criteria:

Significant and/or current neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, repetitive head trauma, serious infection of the brain, Parkinson's disease, epilepsy, or cervicocranial vascular disease.
Participants with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the participant's ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded.
Within 1 year before the screening visit or between screening and randomization, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (such as, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia.
Congenital QT prolongation.
Intermittent second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
A corrected QT (QTcF) interval measurement >470 milliseconds (men and women) at screening (as determined at the investigational site).
History of malignant cancer within the last 5 years.
History of vitiligo and/or current evidence of post-inflammatory hypopigmentation.
Calculated creatinine clearance <30 milliliters per minute (Cockcroft-Gault formula; Cockcroft and Gault 1976) at screening.
Currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Lanabecestat 20 milligrams (mg)

Lanabecestat 50 mg

Placebo/ Lanabecestat 20 mg

Placebo/ Lanabecestat 50 mg

Arm Description

Participants received Lanabecestat 20 mg film-coated tablets orally once daily until week 156.

Participants received Lanabecestat 50 mg film-coated tablets orally once daily until week 156.

Placebo given orally once daily for 78 weeks and then 20 mg of lanabecestat given orally once daily until week 156.

Placebo given orally once daily for 78 weeks and then 50 mg of lanabecestat given orally once daily until week 156.

Outcomes

Primary Outcome Measures

Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score

ADAS-Cog13 (13-item version of ADAS Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment-by-visit interaction, acetylcholinesterase Inhibitor (AChEI) use at baseline, pooled site, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.

Secondary Outcome Measures

Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL)

The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction.

Change From Baseline in Functional Activities Questionnaire (FAQ) Score

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). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline FAQ total score, by-visit interaction and age at baseline.

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score

The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction.

Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

The CDR-SB is a rater administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which no dementia = 0, questionable dementia = 0.5, mild dementia = 1, moderate dementia = 2 and severe dementia = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline CDR-SB score, age at baseline, and baseline CDR-SB score-by-visit interaction.

Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage

The CDR global score is a composite score calculated using the Washington University CDR-assignment algorithm applied to the 6 individual domain box scores (Morris 1993). The memory domain is considered the primary category that drives the CDR global outcome, and all other domains are secondary. The CDR global score ranges from 0 to 3 (0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia).

Change From Baseline in Neuropsychiatric Inventory (NPI) Score

The NPI is a questionnaire administered to caregivers that quantifies behavioral changes. 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, with higher scores indicating a greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline NPI score, age at baseline, and baseline NPI score-by-visit interaction.

Change From Baseline on the Mini-Mental State Examination (MMSE)

The MMSE is an instrument used to assess a participant's global cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction.

Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42

Concentration of the peptide Aβ 1-42 in plasma measured by validated immunoassay. LS Mean was determined by Analysis of covariance (ANCOVA) with last observation carried forward (LOCF), terms for treatment, baseline biomarker and age at baseline.

Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40

Concentration of the peptide Aβ 1-40 in plasma measured by immunoassay. LS Mean was determined by ANCOVA with LOCF (last observation carried forward), terms for treatment, baseline biomarker and age at baseline.

Change From Baseline in CSF Biomarker Total Tau

Cerebrospinal fluid samples were collected for analysis of concentration total tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, baseline biomarker and age at baseline.

Change From Baseline in CSF Biomarker Phosphorylated Tau

Cerebrospinal fluid samples are collected for analysis of concentration of phosphorylated tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, baseline biomarker and age at baseline.

Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan

Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease. Florbetapir exhibits high affinity specific binding to amyloid plaques. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by florbetapir amyloid PET imaging in a subset of participants. The Centiloid scale standardizes quantitative brain amyloid PET results to allow cross-tracer and cross-methodology comparisons. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans. Florbetapir SUVr was converted to the Centiloid scale using the following conversion: Florbetapir Centiloids = 183 x SUVr - 177. LS Mean was determined by using ANCOVA methodology with terms for treatment, baseline biomarker and age at baseline.

Change From Baseline in Regional Cerebral Blood Flow (rCBF) Using Florbetapir Perfusion Scan

Florbetapir perfusion evaluated the regional cerebral blood flow (rCBF) as a biomarker of brain function and was performed at the same time as the amyloid florbetapir PET. Cerebral perfusion, especially in temporal and parietal areas, is reduced in AD and this pattern of hypoperfusion closely mirrors the hypometabolism pattern observed using FDG PET. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA with LOCF (last observation carried forward) and with factors for treatment, baseline biomarker and age at baseline.

Change From Baseline in Whole Brain Volume

Magnetic resonance imaging (MRI) was used to evaluate the effect of lanabecestat on brain atrophy/whole brain volumes. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, baseline volumetric magnetic resonance imaging (vMRI), intracranial volume and age at baseline.

Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat

The apparent oral clearance of lanabecestat was estimated using a population approach. No covariate effects were assessed as part of this analysis.

Population PK: Central Volume of Distribution of Lanabecestat

The central volume of distribution for lanabecestat was estimated using a population approach. No covariate effects were assessed as part of this analysis.

Full Information

NCT ID

NCT02783573

First Posted

May 24, 2016

Last Updated

November 19, 2019

Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02783573

Brief Title

A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia

Acronym

DAYBREAK-ALZ

Official Title

A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Terminated

Why Stopped

An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.

Study Start Date

July 1, 2016 (Actual)

Primary Completion Date

September 28, 2018 (Actual)

Study Completion Date

September 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main purpose of this study is to evaluate the efficacy of the study drug known as lanabecestat in participants with mild Alzheimer's disease (AD) dementia.

6. Conditions and Keywords

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

Alzheimer's Disease

Keywords

dementia, brain diseases, neurodegenerative diseases, central nervous system diseases, nervous system diseases, mental disorders, delirium, dementia, amnestic, cognitive, tauopathies, memory, amyloid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1722 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lanabecestat 20 milligrams (mg)

Arm Type

Experimental

Arm Description

Participants received Lanabecestat 20 mg film-coated tablets orally once daily until week 156.

Arm Title

Lanabecestat 50 mg

Arm Type

Experimental

Arm Description

Participants received Lanabecestat 50 mg film-coated tablets orally once daily until week 156.

Arm Title

Placebo/ Lanabecestat 20 mg

Arm Type

Experimental

Arm Description

Placebo given orally once daily for 78 weeks and then 20 mg of lanabecestat given orally once daily until week 156.

Arm Title

Placebo/ Lanabecestat 50 mg

Arm Type

Experimental

Arm Description

Placebo given orally once daily for 78 weeks and then 50 mg of lanabecestat given orally once daily until week 156.

Intervention Type

Drug

Intervention Name(s)

Lanabecestat

Other Intervention Name(s)

LY3314814, AZD3293

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score

Description

Time Frame

Baseline, Week 78

Secondary Outcome Measure Information:

Title

Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL)

Description

Time Frame

Baseline, Week 78

Title

Change From Baseline in Functional Activities Questionnaire (FAQ) Score

Description

Time Frame

Baseline, Week 78

Title

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score

Description

Time Frame

Baseline, Week 78

Title

Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

Description

Time Frame

Baseline, Week 78

Title

Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage

Description

Time Frame

From Loss of 1 Global Stage through Week 78

Title

Change From Baseline in Neuropsychiatric Inventory (NPI) Score

Description

Time Frame

Baseline, Week 78

Title

Change From Baseline on the Mini-Mental State Examination (MMSE)

Description

Time Frame

Baseline, Week 78

Title

Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42

Description

Time Frame

Baseline, Week 71

Title

Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40

Description

Time Frame

Baseline, Week 71

Title

Change From Baseline in CSF Biomarker Total Tau

Description

Cerebrospinal fluid samples were collected for analysis of concentration total tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, baseline biomarker and age at baseline.

Time Frame

Baseline, Week 71

Title

Change From Baseline in CSF Biomarker Phosphorylated Tau

Description

Time Frame

Baseline, Week 71

Title

Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan

Description

Time Frame

Baseline, Week 78

Title

Change From Baseline in Regional Cerebral Blood Flow (rCBF) Using Florbetapir Perfusion Scan

Description

Time Frame

Baseline, Week 78

Title

Change From Baseline in Whole Brain Volume

Description

Time Frame

Baseline, Week 78

Title

Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat

Description

The apparent oral clearance of lanabecestat was estimated using a population approach. No covariate effects were assessed as part of this analysis.

Time Frame

Predose, Week 4, 7, 19, 39, 45 and Week 71 post dose

Title

Population PK: Central Volume of Distribution of Lanabecestat

Description

The central volume of distribution for lanabecestat was estimated using a population approach. No covariate effects were assessed as part of this analysis.

Time Frame

Predose, Week 4, 7, 19, 39, 45 and week 71 post dose

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: Participant must meet the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (NIA-AA) criteria for probable AD dementia. MMSE score of 20 to 26 inclusive at screening visit. For a diagnosis of mild AD dementia, participant must have a CDR global score of 0.5 or 1, with the memory box score ≥0.5 at screening. Evidence of amyloid pathology. The participant must have a reliable study partner with whom he/she cohabits or has regular contact. Exclusion Criteria: Significant and/or current neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, repetitive head trauma, serious infection of the brain, Parkinson's disease, epilepsy, or cervicocranial vascular disease. Participants with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the participant's ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded. Within 1 year before the screening visit or between screening and randomization, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (such as, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia. Congenital QT prolongation. Intermittent second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia. A corrected QT (QTcF) interval measurement >470 milliseconds (men and women) at screening (as determined at the investigational site). History of malignant cancer within the last 5 years. History of vitiligo and/or current evidence of post-inflammatory hypopigmentation. Calculated creatinine clearance <30 milliliters per minute (Cockcroft-Gault formula; Cockcroft and Gault 1976) at screening. Currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this 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

Xenoscience

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

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

Four Peaks Neurology

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Arizona Neurology

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85260

Country

United States

Facility Name

Center for Neurosciences

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85718

Country

United States

Facility Name

NEA Baptist Clinical

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

The Research Center of Southern California

City

Carlsbad

State/Province

California

ZIP/Postal Code

92011

Country

United States

Facility Name

WCCT Global

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

Country

United States

Facility Name

Neuro-Pain Medical Center

City

Fresno

State/Province

California

ZIP/Postal Code

93710

Country

United States

Facility Name

Neurology Center of North Orange County

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Pacific Neuroscience Medical Group

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

California Research Foundation

City

San Diego

State/Province

California

ZIP/Postal Code

92103-6204

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

Syrentis Clinical Research

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

Care Access Research

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

Associated Neurologists, PC - Danbury

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

Institute for Neurodegenerative Disorders

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

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

Research Center for Clinical Studies, Inc

City

Norwalk

State/Province

Connecticut

ZIP/Postal Code

06851

Country

United States

Facility Name

JEM Research Institute

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Morton Plant Hospital

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33755

Country

United States

Facility Name

Brain Matters Research

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33445

Country

United States

Facility Name

Cohen Medical Associates P.A.

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33446

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

Indago Research & Health Center, Inc.

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Infinity Clinical Research, LLC

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Jacksonville Center for Clinical Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Mayo Clinic-Jacksonville

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Gregory A. Kirk MD LLC

City

Merritt Island

State/Province

Florida

ZIP/Postal Code

32955

Country

United States

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Allied Biomedical Research Institute, Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Compass Research

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Quantum Laboratories

City

Pompano Beach

State/Province

Florida

ZIP/Postal Code

33064

Country

United States

Facility Name

Charlotte Neurological Services

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33980

Country

United States

Facility Name

Intercoastal Medical Group

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Axiom Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33616

Country

United States

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30329

Country

United States

Facility Name

Atlanta Center of Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Georgia Regents University

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

Medical Research Health and Education Foundation, Inc

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31909

Country

United States

Facility Name

Hawaii Medical Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96817

Country

United States

Facility Name

Advanced Clinical Research LLC

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

American Health Network

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Josephson Wallack Munshower Neurology

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

American Health Network

City

Muncie

State/Province

Indiana

ZIP/Postal Code

47304

Country

United States

Facility Name

University of Kansas Hospital

City

Fairway

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Cotton O'Neil Clinic

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Via Christi Research, Inc.

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Baptist Health Medical Group

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Associates in Neurology, PSC

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40513

Country

United States

Facility Name

Eastern Maine Medical Center

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Maine Neurology

City

Scarborough

State/Province

Maine

ZIP/Postal Code

04074

Country

United States

Facility Name

Boston University Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

Donald S Marks

City

Plymouth

State/Province

Massachusetts

ZIP/Postal Code

02360-4843

Country

United States

Facility Name

Alzheimers Disease Center

City

Winchester

State/Province

Massachusetts

ZIP/Postal Code

01890

Country

United States

Facility Name

Michigan State University

City

East Lansing

State/Province

Michigan

ZIP/Postal Code

48824

Country

United States

Facility Name

Hattiesburg Clinic

City

Hattiesburg

State/Province

Mississippi

ZIP/Postal Code

39401

Country

United States

Facility Name

Clinical Research Professionals

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Las Vegas Medical Research

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89113

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

Neurology Specialists of Monmouth County

City

West Long Branch

State/Province

New Jersey

ZIP/Postal Code

07764

Country

United States

Facility Name

New York University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Behavioral Health Center Research

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28211

Country

United States

Facility Name

Raleigh Neurology Associates

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

PMG Research of Winston-Salem, LLC

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Wake Forest Baptist Univ CAR

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Rapid Medical Research Inc

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Ohio State University Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Insight Clinical Trials

City

Shaker Heights

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Lynn Health Science Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Cutting Edge Research Group

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

The Corvallis Clinic P.C.

City

Corvallis

State/Province

Oregon

ZIP/Postal Code

97330

Country

United States

Facility Name

Summit Research Network Inc

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Clinical Trial Center, LLC, Psychiatry

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

Pearl Clinical Research Inc.

City

Norristown

State/Province

Pennsylvania

ZIP/Postal Code

19401

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

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Butler Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Radiant Research

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

Coastal Neurology PA

City

Port Royal

State/Province

South Carolina

ZIP/Postal Code

29935

Country

United States

Facility Name

Holston Medical Group Clinical Research

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

Univ of North Texas Health Science Center

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

Country

United States

Facility Name

Texas Medical Research Associates, L.L.C.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78238

Country

United States

Facility Name

Ericksen Research and Development

City

Clinton

State/Province

Utah

ZIP/Postal Code

84015

Country

United States

Facility Name

SSM Health Dean Medical Group

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53715

Country

United States

Facility Name

University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 426

Country

Canada

Facility Name

The Medical Arts Health Research Group

City

West Vancouver

State/Province

British Columbia

ZIP/Postal Code

V7T223

Country

Canada

Facility Name

True North Clinical Research Halifax, LLC

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3S1M7

Country

Canada

Facility Name

Bruyere Continuing Care

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1N 5C8

Country

Canada

Facility Name

Kawartha Regional Memory Clinic

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9H2P4

Country

Canada

Facility Name

Toronto Memory Program

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3B2S7

Country

Canada

Facility Name

Toronto Sunnybrook Regional Cancer Center

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

CSSS-Institut Universitaire Gériatric de Sherbrooke

City

Sherbrooke

State/Province

Qubec

ZIP/Postal Code

J1J3H5

Country

Canada

Facility Name

Recherches Neuro-Hippocampe Inc

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8T 8J1

Country

Canada

Facility Name

Q&T Research Sherbrooke Inc

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1J 2G2

Country

Canada

Facility Name

Douglas Hospital and Research Centre

City

Verdun

State/Province

Quebec

ZIP/Postal Code

H4H 1R3

Country

Canada

Facility Name

Xuanwu Hospital-Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

Facility Name

Beijing 301 Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

Guangzhou First People's Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510180

Country

China

Facility Name

Tangshan Worker Hospital

City

Tangshan

State/Province

Hebei

ZIP/Postal Code

063000

Country

China

Facility Name

Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210008

Country

China

Facility Name

Zhongda Hospital-Southeast University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

Facility Name

Northern Jiangsu People's Hospital

City

Yangzhou

State/Province

Jiangsu

ZIP/Postal Code

225001

Country

China

Facility Name

Qingdao Municipal Hospital

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266071

Country

China

Facility Name

Shanghai Tongji Hospital(CCBR site)

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200065

Country

China

Facility Name

West China Hospital of Sichuan University

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

The First Affiliated Hospital, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Facility Name

The First Affiliated Hospital of Wenzhou Medical College

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325035

Country

China

Facility Name

Shanghai Huashan Hospital Affil to Fu Dan University

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Fakultni nemocnice u sv. Anny v Brne

City

Brno

ZIP/Postal Code

65691

Country

Czechia

Facility Name

Neurohk s.r.o.

City

Chocen

ZIP/Postal Code

565 01

Country

Czechia

Facility Name

Neuropsychiatrie s.r.o

City

Hradec Kralove

ZIP/Postal Code

50009

Country

Czechia

Facility Name

Brain-Soultherapy s.r.o

City

Kladno

ZIP/Postal Code

27201

Country

Czechia

Facility Name

A-Shine s.r.o.

City

Plzen

ZIP/Postal Code

31200

Country

Czechia

Facility Name

Clintrial, s.r.o.

City

Praha 10

ZIP/Postal Code

100 00

Country

Czechia

Facility Name

Neuropsychiatrie s.r.o

City

Praha 6

ZIP/Postal Code

160 00

Country

Czechia

Facility Name

Medical Services Prague s.r.o.

City

Praha 6

ZIP/Postal Code

16000

Country

Czechia

Facility Name

Axon Clinical, s.r.o.

City

Praha 8

ZIP/Postal Code

182 00

Country

Czechia

Facility Name

CCBR-Alborg-DK

City

Aalborg

ZIP/Postal Code

9100

Country

Denmark

Facility Name

Center For Clinical and Basic Research

City

Ballerup

ZIP/Postal Code

2750

Country

Denmark

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100 CPH

Country

Denmark

Facility Name

Center for Clinical and Basic Research -CCBR

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Facility Name

Institut Claude Pompidou - CMRR

City

Nice

State/Province

Alpes Maritimes

ZIP/Postal Code

06100

Country

France

Facility Name

CHU Rennes/Hopital Sud

City

Rennes Cedex

State/Province

Ille Et Vilaine

ZIP/Postal Code

35064

Country

France

Facility Name

CHU Saint Etienne - Hopital Nord

City

Saint Priest en Jarez

State/Province

Loire

ZIP/Postal Code

42270

Country

France

Facility Name

Chu De Nancy Hop D'Adultes De Brabois

City

Vandœuvre-lès-Nancy

State/Province

Meurthe-et-Moselle

ZIP/Postal Code

54511

Country

France

Facility Name

CHU d'Amiens-Picardie Hopital Sud

City

Amiens Cedex 1

ZIP/Postal Code

80054

Country

France

Facility Name

CHU de Caen Hopital Cote de Nacre

City

Caen Cedex

ZIP/Postal Code

14033

Country

France

Facility Name

APHM Hôpital de la Timone

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Hôpital de la Pitié-Salpêtrière

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

CHU Strasbourg Hôpital de Hautepierre

City

Strasbourg Cedex

ZIP/Postal Code

67098

Country

France

Facility Name

Chu de Toulouse Hopital de La Grave

City

Toulouse Cedex

ZIP/Postal Code

31059

Country

France

Facility Name

Praxis Dr. Erich Scholz

City

Böblingen

State/Province

Baden-Württemberg

ZIP/Postal Code

71034

Country

Germany

Facility Name

ISPG - Institut für Studien zur psychischen Gesundheit

City

Mannheim

State/Province

Baden-Württemberg

ZIP/Postal Code

68165

Country

Germany

Facility Name

Praxis für Neurologie und Psychiatrie Dr. med. Roth

City

Ostfildern

State/Province

Baden-Württemberg

ZIP/Postal Code

73760

Country

Germany

Facility Name

Neurozentrum Sophienstraße

City

Stuttgart

State/Province

Baden-Württemberg

ZIP/Postal Code

70178

Country

Germany

Facility Name

Klinikum der Universität München

City

München

State/Province

Bayern

ZIP/Postal Code

81377

Country

Germany

Facility Name

Klinikum Rechts der Isar der TU München

City

München

State/Province

Bayern

ZIP/Postal Code

81675

Country

Germany

Facility Name

Neuropraxis München Süd

City

Unterhaching

State/Province

Bayern

ZIP/Postal Code

82008

Country

Germany

Facility Name

Diakoniekrankenhaus Henriettenstiftung Hannover

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30559

Country

Germany

Facility Name

MVZ LiO Berlin

City

Berlin

ZIP/Postal Code

12209

Country

Germany

Facility Name

Policlinico Univ. Agostino Gemelli

City

Roma

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

Spedali Civili - Universita degli Studi

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Careggi

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Ente Ospedaliero Ospedali Galliera

City

Genova

ZIP/Postal Code

16128

Country

Italy

Facility Name

IRCCS Azienda Ospedaliera Universitaria San Martino

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

SDN - Istituto di Ricerca Diagnostica e Nucleare

City

Napoli

ZIP/Postal Code

80143

Country

Italy

Facility Name

Azienda Ospedaliera - Universitaria Pisana

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

IRCCS Santa Lucia

City

Roma

ZIP/Postal Code

00179

Country

Italy

Facility Name

Universita La Sapienza

City

Roma

ZIP/Postal Code

00185

Country

Italy

Facility Name

Azienda Ospedaliera Citta della Salute della Scienza Torino

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Shinwakai Yachiyo Hospital

City

Anjo-shi

State/Province

Aichi-Ken

ZIP/Postal Code

446-8510

Country

Japan

Facility Name

Nagoya Ekisaikai Hospital

City

Nagoya-shi

State/Province

Aichi-Ken

ZIP/Postal Code

454-8502

Country

Japan

Facility Name

Kojunkai Daido Hospital

City

Nagoya-Shi

State/Province

Aichi-Ken

ZIP/Postal Code

457-8511

Country

Japan

Facility Name

Inage Neurology and Memory Clinic

City

Chiba-shi

State/Province

Chiba-Ken

ZIP/Postal Code

263-0043

Country

Japan

Facility Name

Ehime University Hospital

City

Toon-Shi

State/Province

Ehime-Ken

ZIP/Postal Code

791-0295

Country

Japan

Facility Name

Jisenkai Nanko Psychiatric Institute

City

Shirakawa-shi

State/Province

Fukushima-Ken

ZIP/Postal Code

961-0021

Country

Japan

Facility Name

Takeda General Hospital

City

Aizu-Wakamatsu

State/Province

Fukushima

ZIP/Postal Code

965-8585

Country

Japan

Facility Name

Koseikai Kusatsu Hospital

City

Hiroshima-shi

State/Province

Hiroshima-Ken

ZIP/Postal Code

733-0864

Country

Japan

Facility Name

NHO Hiroshima-Nishi Medical Center

City

Otaki-Shi

State/Province

Hiroshima-Ken

ZIP/Postal Code

739-0696

Country

Japan

Facility Name

Yokohama Hospital

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

221-0801

Country

Japan

Facility Name

Koseikai Takeda Hospital

City

Kyoto-Shi

State/Province

Kyoto-Fu

ZIP/Postal Code

600-8558

Country

Japan

Facility Name

Uji Takeda Hospital

City

Uji-Shi

State/Province

Kyoto-Fu

ZIP/Postal Code

611-0021

Country

Japan

Facility Name

JADECOM Nara City Hospital

City

Nara-Shi

State/Province

Nara-Ken

ZIP/Postal Code

630-8305

Country

Japan

Facility Name

Nara Medical University Hospital

City

Kashihara

State/Province

Nara

ZIP/Postal Code

634-8522

Country

Japan

Facility Name

Oita University Hospital

City

Yufu-shi

State/Province

Oita-Ken

ZIP/Postal Code

879-5593

Country

Japan

Facility Name

Katayama Medical Clinic

City

Kurashiki-shi

State/Province

Okayama-Ken

ZIP/Postal Code

710-0813

Country

Japan

Facility Name

Himuro Neurology Clinic

City

Osaka-Shi

State/Province

Osaka-Fu

ZIP/Postal Code

534-0021

Country

Japan

Facility Name

Kotobukikai Tominaga Clinic

City

Osaka-shi

State/Province

Osaka-Fu

ZIP/Postal Code

556-0015

Country

Japan

Facility Name

Kousaiin Hospital

City

Suita-shi

State/Province

Osaka-Fu

ZIP/Postal Code

565-0874

Country

Japan

Facility Name

NHO Hizen Psychiatric Center

City

Kanzaki-gun

State/Province

Saga-Ken

ZIP/Postal Code

842-0192

Country

Japan

Facility Name

Shimizu Hospital

City

Shizuoka-shi

State/Province

Shizuoka

ZIP/Postal Code

424-8636

Country

Japan

Facility Name

Keikokai P-One Clinic

City

Hachioji-shi

State/Province

Tokyo-To

ZIP/Postal Code

192-0071

Country

Japan

Facility Name

Memory Clinic Ochanomizu

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-0034

Country

Japan

Facility Name

Juntendo University Hospital

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Musashino Red Cross Hospital

City

Musashino

State/Province

Tokyo

ZIP/Postal Code

180-8610

Country

Japan

Facility Name

JOHAS Sanin Rosai Hospital

City

Yonago-shi

State/Province

Tottori-Ken

ZIP/Postal Code

683-8605

Country

Japan

Facility Name

Aomori Prefectural Centeral Hospital

City

Aomori

ZIP/Postal Code

030-8553

Country

Japan

Facility Name

Ikeuchi Psycho Induced Internal Clinic

City

Kobe-shi

ZIP/Postal Code

655-0037

Country

Japan

Facility Name

Yuge Hospital

City

Kumamoto

ZIP/Postal Code

861-8002

Country

Japan

Facility Name

NHO Niigata Hospital

City

Niigata

ZIP/Postal Code

945-8585

Country

Japan

Facility Name

NHO Hokkaido Medical Center

City

Sapporo-shi

ZIP/Postal Code

063-0005

Country

Japan

Facility Name

Dong-A University Medical Center

City

Busan

State/Province

Busan Gwang'yeogsi

ZIP/Postal Code

49201

Country

Korea, Republic of

Facility Name

The Catholic University of Korea-Bucheon St. Mary's Hospital

City

Bucheon-si

State/Province

Gyeonggi-do

ZIP/Postal Code

14647

Country

Korea, Republic of

Facility Name

Myongji Hospital

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Inha University Hospital

City

Incheon

ZIP/Postal Code

22332

Country

Korea, Republic of

Facility Name

Korea University Anam Hospital

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Hanyang University Medical Center

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

Konkuk University Hospital

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Hospital Universitario de Saltillo

City

Saltillo

State/Province

Coahuila

ZIP/Postal Code

25000

Country

Mexico

Facility Name

Mexico Centre for Clinical Research SA de CV

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Clinical Research Institute S C

City

Tlalnepantla

State/Province

Edo De Mex

ZIP/Postal Code

54055

Country

Mexico

Facility Name

Hospital Univ. Jose Eleuterio Gonzalez

City

Monterrey

State/Province

N.l.

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Instituto de Informacion en Salud Mental (INFOSAM)

City

Monterrey

State/Province

ZIP/Postal Code

64710

Country

Mexico

Facility Name

Accelerium Clinical Research

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64000

Country

Mexico

Facility Name

Centro de Estudios Clinicos y Esp Medicas SC

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64620

Country

Mexico

Facility Name

Avix Investigación Clínica, S.C

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64710

Country

Mexico

Facility Name

Emotional Brain B.V.

City

Almere

ZIP/Postal Code

1311 RL

Country

Netherlands

Facility Name

Brain Research Center

City

Amsterdam

ZIP/Postal Code

1081 GM

Country

Netherlands

Facility Name

Amphia Ziekenhuis

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

EB Utrecht

City

Utrecht

ZIP/Postal Code

3511 NH

Country

Netherlands

Facility Name

Isala Klinieken

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

NZOZ Wroclawskie Centrum Alzheimerowskie

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

53 139

Country

Poland

Facility Name

Podlaskie Centrum Psychogeriatrii

City

Białystok

State/Province

Podlaskie

ZIP/Postal Code

15-732

Country

Poland

Facility Name

Uniwersyteckie Centrum Kliniczne

City

Gdansk

State/Province

Pomorskie

ZIP/Postal Code

80-952

Country

Poland

Facility Name

NZOZ Mach-Med

City

Chorzow

ZIP/Postal Code

41-506

Country

Poland

Facility Name

Klinika Neurologii Neuro-Care

City

Katowice

ZIP/Postal Code

40749

Country

Poland

Facility Name

Globe Badania Kliniczne SP Z O.O.

City

Klodzko

ZIP/Postal Code

57-300

Country

Poland

Facility Name

Prywatny Gabinet Lekarski U.Chyrchel

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

Centrum Medyczne Medyk

City

Rzeszow

ZIP/Postal Code

35-055

Country

Poland

Facility Name

Euromedis Sp. z o.o.

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Clinsante Centrum Medyczne

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Centrum Medyczne

City

Warszawa

ZIP/Postal Code

01-697

Country

Poland

Facility Name

Specjalistyczny Osrodek Medycyny Wieku Dojrzalego SOMED

City

Warszawa

ZIP/Postal Code

01-737

Country

Poland

Facility Name

Hospital Fernando Fonseca

City

Amadora

ZIP/Postal Code

2700-351

Country

Portugal

Facility Name

Hospital de Braga

City

Braga

ZIP/Postal Code

4710-243

Country

Portugal

Facility Name

Hospitals da Universidade de Coimbra

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

SAIH Republ. Clinical Hospital of the MoH of Republ. Tatarst

City

Kazan

ZIP/Postal Code

420064

Country

Russian Federation

Facility Name

SIH Kemerovo Regional Clinical Hosptial

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Facility Name

FSBIH Siberian Clinical Center of FMBA

City

Krasnoyarsk

ZIP/Postal Code

660049

Country

Russian Federation

Facility Name

LLC City Neurological Centre Sibneuromed

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

Novosibirsk State Medical University

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

Ultramed

City

Omsk

ZIP/Postal Code

644024

Country

Russian Federation

Facility Name

LLC Treatment and Rehabilitation

City

Rostov-on-Don

ZIP/Postal Code

344010

Country

Russian Federation

Facility Name

RSBIH Smolensk Regional Clinical Hospital

City

Smolensk

ZIP/Postal Code

214018

Country

Russian Federation

Facility Name

Bekhterev Psyconeurological Institute

City

St. Petersburg

ZIP/Postal Code

192019

Country

Russian Federation

Facility Name

Central Medical Sanitary Hospital #122

City

St. Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Regional State Institution of Healthcare Tomsk Clinica Psych

City

Tomsk

ZIP/Postal Code

634014

Country

Russian Federation

Facility Name

Hospital Cardiovascular San Vicente

City

San Vicente del Raspeig

State/Province

Alicante

ZIP/Postal Code

03690

Country

Spain

Facility Name

Hospital General de Catalunya

City

Sant Cugat del Valles

State/Province

Barcelona

ZIP/Postal Code

08190

Country

Spain

Facility Name

Hospital Mutua de Terrassa

City

Terrassa

State/Province

Barcelona

ZIP/Postal Code

08221

Country

Spain

Facility Name

Hospital Virgen Del Puerto

City

Plasencia

State/Province

Caceres

ZIP/Postal Code

10600

Country

Spain

Facility Name

Policlinica Guipuzcoa

City

Donostia

State/Province

Guipuzcoa

ZIP/Postal Code

20009

Country

Spain

Facility Name

Hospital Ntra Sra Perpetuo Socorro

City

Albacete

ZIP/Postal Code

02006

Country

Spain

Facility Name

Hospital del Mar

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Fundacion ACE-Institut Catala de Neurociences Aplicades

City

Barcelona

ZIP/Postal Code

08028

Country

Spain

Facility Name

Hospital Universitario La Fe de Valencia

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Cardinal Tien Hospital

City

Sindian City

State/Province

Taipei County

ZIP/Postal Code

23148

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Douliu

State/Province

Yunlin County

ZIP/Postal Code

640

Country

Taiwan

Facility Name

Changhua Christian Hospital

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Kaohsiung Medical University Chung-Ho Memorial Hospital

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital - Kaohsiung

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Taipei Medical University- Shuang Ho Hospital

City

New Taipei

ZIP/Postal Code

23561

Country

Taiwan

Facility Name

National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital - Linkou

City

Taoyuan City

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Royal Devon and Exeter Hospital

City

Exeter

State/Province

Devon

ZIP/Postal Code

EX2 5DW

Country

United Kingdom

Facility Name

Re-Cognition Health Ltd

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL6 8BT

Country

United Kingdom

Facility Name

Charlton Lane Hospital

City

Cheltenham

State/Province

Gloucestershire

ZIP/Postal Code

GL53 9DZ

Country

United Kingdom

Facility Name

Re-Cognition Health Ltd

City

Guildford

State/Province

Surrey

ZIP/Postal Code

GU2 7YD

Country

United Kingdom

Facility Name

Murray Royal Hospital

City

Perth

State/Province

Tayside Region

ZIP/Postal Code

PH2 7BH

Country

United Kingdom

Facility Name

Victoria Centre

City

Swindon

State/Province

Wiltshire

ZIP/Postal Code

SN3 6BW

Country

United Kingdom

Facility Name

Glasgow Memory Clinic

City

Glasgow

ZIP/Postal Code

G20 0XA

Country

United Kingdom

Facility Name

Re-Cognition Health Ltd

City

London

ZIP/Postal Code

W1G9JF

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://www.clinicalstudydatarequest.com/

Citations:

PubMed Identifier

31764959

Citation

Wessels AM, Tariot PN, Zimmer JA, Selzler KJ, Bragg SM, Andersen SW, Landry J, Krull JH, Downing AM, Willis BA, Shcherbinin S, Mullen J, Barker P, Schumi J, Shering C, Matthews BR, Stern RA, Vellas B, Cohen S, MacSweeney E, Boada M, Sims JR. Efficacy and Safety of Lanabecestat for Treatment of Early and Mild Alzheimer Disease: The AMARANTH and DAYBREAK-ALZ Randomized Clinical Trials. JAMA Neurol. 2020 Feb 1;77(2):199-209. doi: 10.1001/jamaneurol.2019.3988. Erratum In: JAMA Neurol. 2020 Sep 1;77(9):1179.

Results Reference

derived

PubMed Identifier

27767991

Citation

Cebers G, Alexander RC, Haeberlein SB, Han D, Goldwater R, Ereshefsky L, Olsson T, Ye N, Rosen L, Russell M, Maltby J, Eketjall S, Kugler AR. AZD3293: Pharmacokinetic and Pharmacodynamic Effects in Healthy Subjects and Patients with Alzheimer's Disease. J Alzheimers Dis. 2017;55(3):1039-1053. doi: 10.3233/JAD-160701.

Results Reference

derived

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=16024&attachmentIdentifier=57afcbfd-0b6e-419e-bfa4-31474a88e3b0&fileName=CSP_NCT02783573.pdf&versionIdentifier=

Description

CSP

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=16024&attachmentIdentifier=88ccbed4-c60c-4494-8962-a9b57b36e8de&fileName=SAP_NCT02783573.pdf&versionIdentifier=

Description

SAP

Learn more about this trial

A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia

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A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia (DAYBREAK-ALZ)

Alzheimer's Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial