Alzheimer Dementia (AD)NCT06330155
A Genetic Study for Alzheimer Dementia: Case-control Study
An observational study of Alzheimer Dementia (AD), run by MinYoung Kim, MD, PhD.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Dementia (AD)
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 26 Mar 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 Alzheimer's dementia patients 10 healthy subjects
- 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.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
- Conditions
- Alzheimer Dementia (AD)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's dementia patient and healthy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic analysis
5cc blood collection for genetic testing
Measured: Baseline
Secondary outcomes (3)
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.
Measured: 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)
Measured: 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".
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start26 Mar 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Dementia (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MinYoung Kim, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MinYoung Kim, MD, PhD, Bundang CHA Hospital
- Investigators
- MinYoung Kim, MD, PhD, Principal investigator, CHA Bundang Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330155
- Sponsor's protocol ID
- 2024-01-032
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Genetic Study for Alzheimer Dementia: Case-control Study
- ClinicalTrials.gov ID
- NCT06330155
- Acronym / sponsor ID
- 2024-01-032
- Conditions
- Alzheimer Dementia (AD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MinYoung Kim, MD, PhDUniversity, hospital or other
- Study start
- 26 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's dementia patient and healthy subjects | – | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 Alzheimer's dementia patients 10 healthy subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
genetic analysis
Time frame: Baseline
5cc blood collection for genetic testing
3 secondary outcomes
Measurement of Korean version of mini-mental state examination (K-MMSE)
Time frame: screening, Baseline
Measurement of Clinical Dementia Rating (CDR)
Time frame: screening, Baseline
Measurement of Geriatric Depression Scale (GDSd)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
Related trials for Alzheimer Dementia (AD)
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Not yet recruiting
VICA: A Virtual Care Assistant for Dementia Caregivers
Alzheimer Dementia (AD), Caregiver Burden of People With Dementia
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Active, not recruitingPhase 1/2
VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants With Early Alzheimer's Disease
Alzheimer's Disease (AD)
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MinYoung Kim, MD, PhD principal investigator
CHA Bundang Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Dementia (AD), run by MinYoung Kim, MD, PhD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MinYoung Kim, MD, PhD (82-31-780-6281, kmin@cha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genetic analysis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.