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NCT Number: NCT06330155

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.

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Key information

Conditions

Alzheimer Dementia (AD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.)

Treatment and study plan

Primary outcomes

  1. genetic analysis

    Time frame: Baseline

    5cc blood collection for genetic testing

Secondary outcomes

  1. 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.

  2. 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)

  3. 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".

Study contacts

Contact information is provided by the study sponsor or research team.

MinYoung Kim, MD, PhD

CONTACT

[email protected]

82-31-780-6281

Sponsors and collaborators

Lead sponsor

MinYoung Kim, MD, PhD

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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