AzTrials
AzTrials

Mild Cognitive ImpairmentCONCORDENCT03448445

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 of Mild Cognitive Impairment, run by Eisai Korea Inc. at 16 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 to 89 years
Conditions the study is for
Mild Cognitive Impairment
How many people
201 participants
Where
16 sitesSouth Korea
Study dates
22 Jun 2018to 10 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with mild cognitive impairment

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

South Korea16 sites

  • Eisai Trial site_12

    Anyang

  • Eisai Trial site_11

    Busan

  • Eisai Trial site_15

    Busan

  • Eisai Trial site_08

    Changwon

  • Eisai Trial site_09

    Daegu

  • Eisai Trial site_05

    Daejeon

  • Eisai Trial site_03

    Gachon

  • Eisai Trial site_07

    Guri-si

  • Eisai Trial site_10

    Gwangju

  • Eisai Trial site_16

    Jeju City

  • Eisai Trial site_01

    Seoul

  • Eisai Trial site_02

    Seoul

  • Eisai Trial site_04

    Seoul

  • Eisai Trial site_06

    Seoul

  • Eisai Trial site_13

    Seoul

  • Eisai Trial site_14

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Being tested
Usual care setting
Keywords
High-risk, Low-risk, Alzheimer's disease, Observational study
Medical subject headings
Cognitive Dysfunction, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual care settingOther

    usual care settings without any intervention

Study groups in NCT03448445
Study groupRoleWhat they receive
High-risk MCIThis cohort will include participants with high-risk mild cognitive impairment (MCI).
Receives: Other: Usual care setting
Low-risk MCIThis cohort will include participants with low-risk MCI.
Receives: Other: Usual care setting

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 36 months

Secondary outcomes (7)

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

    Measured: Baseline, Month 12, Month 24

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

    Measured: Baseline, Month 12, Month 24

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

    Measured: Baseline, Month 12, Month 24

  4. Mean change from Baseline in Geriatric Depression Scale scores

    Measured: Baseline, Month 12, Month 24

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

    Measured: Baseline, Month 12, Month 24

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

    Measured: Baseline, Month 12, Month 24

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

    Measured: Baseline, Month 12, Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2018
  2. Study start22 Jun 2018
  3. Primary completion10 Aug 2021
  4. Study completion10 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448445
Sponsor's protocol ID
E0000-M082-603
Acronym
CONCORDE
Status last verified
May 2021
First submitted
22 Feb 2018
Last updated
6 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jang H, Na DL, Kwon JC, Jung NY, Moon Y, Lee JS, Park KW, Lee AY, Cho H, Lee JH, Kim BC, Park KH, Lee BC, Choi H, Kim J, Park MY. A Two-Year Observational Study to Evaluate Conversion Rates from High- and Low-Risk Patients with Amnestic Mild Cognitive Impairment to Probable Alzheimer's Disease in a Real-World Setting. J Alzheimers Dis Rep. 2024 May 17;8(1):851-862. doi: 10.3233/ADR-230189. eCollection 2024.

    PubMed 38910942

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Cognitive Impairment, run by Eisai Korea Inc. at 16 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03448445, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
CONCORDE Clinical Trial NCT03448445 | AzTrials