A Genetic Study for Alzheimer Dementia: Case-control Study | NCT06330155

Studies
A Genetic Study for Alzheimer Dementia: Case-control Study

NCT06330155

Sponsor

MinYoung Kim, MD, PhD

Status

Not yet recruiting

Last Update Posted

Apr 4, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Alzheimer Dementia (AD)

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 26, 2024Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 19, 2024

First Submission Date that Met QC Criteria

Mar 19, 2024

First Posted Date

Mar 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2024

Last Update Posted Date

Apr 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
Alzheimer's dementia patient and healthy subjects

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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
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
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.)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

10 Alzheimer's dementia patients 10 healthy subjects

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
MinYoung Kim, MD, PhD	Contact	82-31-780-6281		kmin@cha.ac.kr

Name	Affiliation	Role
MinYoung Kim, MD, PhD	CHA Bundang Medical Center	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided