A Genetic Study for Alzheimer Dementia: Case-control Study

Alzheimer Dementia (AD) Clinical Trial

Official title:

A Genetic Study for Alzheimer Dementia: Case-control Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06330155
• Other study ID #: 2024-01-032
• Status: Not yet recruiting
• Start date: March 26, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Bundang CHA Hospital
• Contact: MinYoung Kim, MD, PhD
• Phone: 82-31-780-6281
• Email: kmin[@]cha.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Alzheimer Dementia (AD)
• Alzheimer Disease
• Dementia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MinYoung Kim, MD, PhD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	genetic analysis	5cc blood collection for genetic testing	Baseline
Secondary	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
Secondary	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
Secondary	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