- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03448445
A Study to Evaluate Alzheimer's Disease Conversion Rate Differences Between High-risk Mild Cognitive Impairment (MCI) and Low-risk MCI in a Real World Setting (CONCORDE)
October 5, 2021 updated by: Eisai Korea Inc.
An Observational Study to Evaluate AD Conversion Rate Differences Between High-risk MCI and Low Risk MCI in Real World Setting
This study will be conducted to evaluate the rate of Alzheimer's disease conversion differences between high-risk mild cognitive impairment (MCI) and low-risk MCI.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
201
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Anyang, Korea, Republic of
- Eisai Trial site_12
-
Busan, Korea, Republic of
- Eisai Trial site_11
-
Busan, Korea, Republic of
- Eisai Trial site_15
-
Changwon, Korea, Republic of
- Eisai Trial site_08
-
Daegu, Korea, Republic of
- Eisai Trial site_09
-
Daejeon, Korea, Republic of
- Eisai Trial site_05
-
Gachon, Korea, Republic of
- Eisai Trial site_03
-
Guri, Korea, Republic of
- Eisai Trial site_07
-
Gwangju, Korea, Republic of
- Eisai Trial site_10
-
Jeju, Korea, Republic of
- Eisai Trial site_16
-
Seoul, Korea, Republic of
- Eisai Trial site_01
-
Seoul, Korea, Republic of
- Eisai Trial site_02
-
Seoul, Korea, Republic of
- Eisai Trial site_04
-
Seoul, Korea, Republic of
- Eisai Trial site_06
-
Seoul, Korea, Republic of
- Eisai Trial site_13
-
Seoul, Korea, Republic of
- Eisai Trial site_14
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 89 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants with mild cognitive impairment
Description
Inclusion Criteria:
- Participant over 55 years old and less than 90 years old
- Participant with subjective memory complaint by informant
- Clinical Dementia Rating (CDR) of 0.5; memory score box must be at least 0.5
- General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit
- Essentially preserved activities of daily living
- Absence of dementia
- Participant with Seoul Neuropsychological Screening Battery-Dementia Version cut-off score between 134.25 and 188.25
- Participants and caregivers who give written authorization to use their personal and health data
- Cognitive decline history within past 6 months from the baseline
Exclusion Criteria:
- Diagnostic evidence of probable Alzheimer's disease consistent with National Institute of Neurological and Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders Association
- CDR-Global score (CDR-GS) >1
- Participant who has taken memantine, acetylcholinesterase inhibitors, or nootropics prior to participating in this study
- Any significant neurologic disease: other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
- Neuroimaging: participant with severe subcortical hyperintensities: D3-P3
- Magnetic resonance imaging exclusions: presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body
- Participant who is pregnant, lactating or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
High-risk MCI
This cohort will include participants with high-risk mild cognitive impairment (MCI).
|
usual care settings without any intervention
|
Low-risk MCI
This cohort will include participants with low-risk MCI.
|
usual care settings without any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Alzheimer's Disease (AD) conversion differences between high-risk mild cognitive impairment (MCI) and low-risk MCI
Time Frame: Up to 36 months
|
AD conversion differences will be assessed according to National Institute of Neurological and Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders Association Criteria for Probable AD.
|
Up to 36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change from Baseline in Seoul Neuropsychological Screening Battery-Dementia Version scores
Time Frame: Baseline, Month 12, Month 24
|
Baseline, Month 12, Month 24
|
Mean change from Baseline in Clinical Dementia Rating (CDR) Sum of Boxes scores
Time Frame: Baseline, Month 12, Month 24
|
Baseline, Month 12, Month 24
|
Mean change from Baseline in the CDR-Global Score
Time Frame: Baseline, Month 12, Month 24
|
Baseline, Month 12, Month 24
|
Mean change from Baseline in Geriatric Depression Scale scores
Time Frame: Baseline, Month 12, Month 24
|
Baseline, Month 12, Month 24
|
Mean change from Baseline in the volume of the whole brain according to Baseline demographics
Time Frame: Baseline, Month 12, Month 24
|
Baseline, Month 12, Month 24
|
Mean change from Baseline in other structural magnetic resonance imaging (MRI) measures according to Baseline demographics
Time Frame: Baseline, Month 12, Month 24
|
Baseline, Month 12, Month 24
|
Mean change from Baseline in the volume of the hippocampus according to Baseline demographics
Time Frame: Baseline, Month 12, Month 24
|
Baseline, Month 12, Month 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2018
Primary Completion (Actual)
August 10, 2021
Study Completion (Actual)
August 10, 2021
Study Registration Dates
First Submitted
February 22, 2018
First Submitted That Met QC Criteria
February 22, 2018
First Posted (Actual)
February 28, 2018
Study Record Updates
Last Update Posted (Actual)
October 6, 2021
Last Update Submitted That Met QC Criteria
October 5, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E0000-M082-603
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mild Cognitive Impairment
-
University of California, San FranciscoNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
-
Xuanwu Hospital, BeijingWuhan University; Beijing Friendship Hospital; First Affiliated Hospital Xi'an... and other collaboratorsRecruitingAmnestic Mild Cognitive ImpairmentChina
-
Immunotec Inc.RecruitingMild Cognitive Impairment (MCI)Canada
-
Jennifer BramenNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Meir Medical CenterTerminatedMild Cognitive Impairment (MCI)Israel
-
First Affiliated Hospital of Zhejiang UniversityUnknownAmnestic Mild Cognitive ImpairmentChina
-
Centre for Addiction and Mental HealthRecruitingAmnestic Mild Cognitive ImpairmentCanada
-
University of FloridaNational Institute on Aging (NIA)RecruitingAmnestic Mild Cognitive ImpairmentUnited States
-
Charite University, Berlin, GermanyCompletedMild Cognitive Impairment (MCI)Germany
-
Johns Hopkins UniversityNational Institute on Aging (NIA)CompletedMild Cognitive Impairment (MCI)United States
Clinical Trials on Usual care setting
-
Johns Hopkins Bloomberg School of Public HealthMedstar Health Research Institute; Johns Hopkins Community PhysiciansCompletedCognitive ImpairmentUnited States
-
Massachusetts General HospitalNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingFrom Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human SubjectsChronic PainUnited States
-
Baylor College of MedicineM.D. Anderson Cancer Center; Michael E. DeBakey VA Medical Center; Agency for...CompletedHypertension | Diabetes
-
Yorkshire Ambulance Service NHS TrustApplied Research Collaboration for Yorkshire and HumberUnknownSafe Paramedic Non-conveyanceUnited Kingdom
-
Charite University, Berlin, GermanyCompletedMultiple Sclerosis | FatigueGermany
-
Aberystwyth UniversityWithdrawn
-
Hanoi Medical UniversityCompleted
-
Centers for Disease Control and PreventionCompleted
-
Charite University, Berlin, GermanyMammazentrum Hamburg am Krankenhaus Jerusalem, Germany; Dorit und Alexander...Completed