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Completed

NCT Number: 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

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.

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Key information

Age range

55 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eisai Trial site_12, Anyang, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Usual care setting

Other

usual care settings without any intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean change from Baseline in Seoul Neuropsychological Screening Battery-Dementia Version scores

    Time frame: Baseline, Month 12, Month 24

  2. Mean change from Baseline in Clinical Dementia Rating (CDR) Sum of Boxes scores

    Time frame: Baseline, Month 12, Month 24

  3. Mean change from Baseline in the CDR-Global Score

    Time frame: Baseline, Month 12, Month 24

  4. Mean change from Baseline in Geriatric Depression Scale scores

    Time frame: Baseline, Month 12, Month 24

  5. Mean change from Baseline in the volume of the whole brain according to Baseline demographics

    Time frame: Baseline, Month 12, Month 24

  6. Mean change from Baseline in other structural magnetic resonance imaging (MRI) measures according to Baseline demographics

    Time frame: Baseline, Month 12, Month 24

  7. Mean change from Baseline in the volume of the hippocampus according to Baseline demographics

    Time frame: Baseline, Month 12, Month 24

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Official study title

An Observational Study to Evaluate AD Conversion Rate Differences Between High-risk MCI and Low Risk MCI in Real World Setting

Acronym: CONCORDE

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2018
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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