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

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.

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

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.

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