A Genetic Study for Alzheimer Dementia: Case-control Study

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: Alzheimer Dementia (AD)

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	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)	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)	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)	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

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

Study record dates

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: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• 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