A Genetic Study for Alzheimer Dementia: Case-control Study

April 2, 2024 updated by: MinYoung Kim, MD, PhD

The purpose of this study is to find out the difference in genetic test results between Alzheimer's dementia patients and healthy subjects.

The investigators want to identify genes that are importantly related to Alzheimer's dementia.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: MinYoung Kim, MD, PhD
  • Phone Number: 82-31-780-6281
  • Email: kmin@cha.ac.kr

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

10 Alzheimer's dementia patients 10 healthy subjects

Description

  1. Inclusion Criteria: Alzheimer's dementia patient

    • Adult patients over 60 years old
    • Patients with a Alzheimer's dementia patient
    • Total Korean version of mini-mental state examination (K-MMSE) score less than 24
    • Total Clinical Dementia Rating (CDR) over 0.5

  2. Inclusion Criteria: healthy subjects

    • Adult healthy over 60 years old
    • Total Korean version of mini-mental state examination (K-MMSE) over 24
    • Total Clinical Dementia Rating (CDR) is 0

  3. Exclusion Criteria:

    • Those with severe medical conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., who are in poor general condition
    • In the case of a person with impaired consent (MMSE less than 10 points), if not accompanied by a guardian
    • Other cases where the researcher determines that participation in this clinical trial is not appropriate (Patients who are participating in other studies or have participated in other studies within the past 30 days can also participate in this study.)

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
Alzheimer's dementia patient and healthy subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
genetic analysis
Time Frame: Baseline
5cc blood collection for genetic testing
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Korean version of mini-mental state examination (K-MMSE)
Time Frame: screening, Baseline
K-MMSE is a measurement of cognitive level. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe(≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment(MCI). The raw score may also need to be corrected for educational attainment and age.
screening, Baseline
Measurement of Clinical Dementia Rating (CDR)
Time Frame: screening, Baseline
CDR is a rating scale for staging patients diagnosed with dementia. The CDR evaluates cognitive, behavioral and functional aspects of Alzheimer disease and other dementias. It is calculated on the basis of testing six different cognitive and behavioral domains such as memory, orientation, judgment and problem solving, community affairs, home and hobbies performance, and personal care. The CDR is based on a scale of 0-3: no dementia (CDR = 0), questionable dementia (CDR = 0.5), MCI (CDR = 1), moderate cognitive impairment (CDR = 2) and severe cognitive impairment (CDR = 3)
screening, Baseline
Measurement of Geriatric Depression Scale (GDSd)
Time Frame: Baseline
GDS is a 30-item self-report assessment used to identify depression in the elderly. One point is assigned to each answer and the cumulative score is rated on a scoring grid. The grid sets a range of 0-9 as "normal", "10-19" as "mildly depressed", and 20-30 as "severely depressed".
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MinYoung Kim, MD, PhD

Investigators

  • Principal Investigator: MinYoung Kim, MD, PhD, CHA Bundang Medical Center

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 (Estimated)

March 26, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-01-032

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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