NCT06330155

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Mar 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

March 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

2.8 years

First QC Date

March 19, 2024

Last Update Submit

April 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • genetic analysis

    5cc blood collection for genetic testing

    Baseline

Secondary Outcomes (3)

  • Measurement of Korean version of mini-mental state examination (K-MMSE)

    screening, Baseline

  • Measurement of Clinical Dementia Rating (CDR)

    screening, Baseline

  • Measurement of Geriatric Depression Scale (GDSd)

    Baseline

Study Arms (1)

Alzheimer's dementia patient and healthy subjects

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

10 Alzheimer's dementia patients 10 healthy subjects

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • MinYoung Kim, MD, PhD

    CHA Bundang Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MinYoung Kim, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 26, 2024

Study Start

March 26, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 4, 2024

Record last verified: 2024-04