CClinicalTrials.gg
CompletedNCT03448445CONCORDEUpdated Oct 6, 2021

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

An observational study in Mild Cognitive Impairment, sponsored by Eisai Korea Inc.. Completed at 16 sites in Korea, Republic of. Open to participants aged 55 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-10-06.

Sponsored by Eisai Korea Inc. · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
201
Ages
55 Years to 89 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • High-risk
  • Low-risk
  • Alzheimer's disease
  • Observational study
03

Who can participate

Ages eligible
55 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants with mild cognitive impairment

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

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)
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
201 participants (actual)
Patient registry
No

Groups and cohorts

  • High-risk MCI

    This cohort will include participants with high-risk mild cognitive impairment (MCI).

    Other: Usual care setting

  • Low-risk MCI

    This cohort will include participants with low-risk MCI.

    Other: Usual care setting

Interventions

  • OtherUsual care setting

    usual care settings without any intervention

05

What researchers measure

Primary outcomes

  1. Rate of Alzheimer's Disease (AD) conversion differences between high-risk mild cognitive impairment (MCI) and low-risk MCI

    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.

    Time frame: Up to 36 months

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

06

Study locations

16 sites
  • Eisai Trial site_12
    Anyang, Korea, Republic of
  • Eisai Trial site_11
    Busan, Korea, Republic of
  • Eisai Trial site_15
    Busan, Korea, Republic of
  • Eisai Trial site_08
    Changwon, Korea, Republic of
  • Eisai Trial site_09
    Daegu, Korea, Republic of
  • Eisai Trial site_05
    Daejeon, Korea, Republic of
  • Eisai Trial site_03
    Gachon, Korea, Republic of
  • Eisai Trial site_07
    Guri, Korea, Republic of
  • Eisai Trial site_10
    Gwangju, Korea, Republic of
  • Eisai Trial site_16
    Jeju, 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
    Seoul, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03448445
Lead sponsor
Eisai Korea Inc.
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Jun 22, 2018
Primary completion
Aug 10, 2021
Completion
Aug 10, 2021
Last update
Oct 6, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion