Mild Cognitive ImpairmentK-ADNINCT01979419
Korea Alzheimer's Disease Neuroimaging Initiative
An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by Korean Alzheimers' Disease Neuroimaing Intitiative at 1 site in South Korea.
Trial summary
PRIMARY OBJECTIVES -Establish a registry for Alzheimer's disease (AD) and subcortical ischemic vascular dementia (SIVD) STUDY DESIGN -This is a non-randomized, natural history, observational, registry study. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease, Subcortical Vascular Dementia
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Oct 2020
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community Sample
Who may be able to join
- Cognitively Normal Subjects
- Mini-Mental State Examination (MMSE) scores between 24-30 (inclusive)
- Clinical Dementia Rating (CDR)=0
- non-depressed (Geriatric Depression Scale scores less than 4)
- no evidence of cognitive impairment
- MCI subjects
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- MMSE scores between 24-30 (inclusive)
- a subjective memory concern reported by subject, informant, or clinician
- objective memory loss measured by age and education year adjusted scores on logical memory sub-test (below -1.5 SD)
- CDR=0.5
- preserved activities of daily living, and an absence of dementia.
- AD subjects
- MMSE scores between 20-26 (inclusive)
- CDR= 0.5 or 1.0.
- meets National Institute of Neurological and Communicative Disorders and Stroke / Alzheimer's Disease and Related Disorders Associations (NINCDS/ADRDA) criteria for probable AD
- vMCI or SIVD
- For diagnosis of vMCI or SIVD, it is necessary to meet the above clinical/cognitive test scores of MCI or AD.
- Presence of vascularity are determined by; 1) more than 2 vascular risk factors in recent 5 years (hypertension, diabetes, stroke, dyslipidemia, other cardiovascular disease, obesity, lack of exercise, and smoking) AND 2) more than 1 evidence of vascular neurological symptom, sign, or history AND 3) neuroimaging evidence of white matter hyperintensity, which is rated moderate or severe on MR T2-weighted image(T2WI) or FLAIR images.
Who cannot join
- Screening/baseline MRI scan with evidence of infection, infarction, or other focal lesions; Participants with multiple lacunes or lacunes in a critical memory structure are excluded
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body
- Major depression, bipolar disorder as described in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) within the past 1 year
- Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder
- History of schizophrenia
- History of alcohol or substance abuse or dependence within the past 2 years
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
- Any significant neurologic disease such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
PRIMARY OBJECTIVES
-Establish a registry for Alzheimer's disease (AD) and subcortical ischemic vascular dementia (SIVD)
Read more
STUDY DESIGN
-This is a non-randomized, natural history, observational, registry study.
SAMPLE SIZE AND RECRUITMENT
- Five hundred subjects will be enrolled at each clinical site (50 NC, 200 with MCI, 50 with AD, 100 with vMCI, and 100 with SIVD)
SUMMARY OF KEY ELIGIBILITY CRITERIA
- Newly enrolled subjects will be between 50-80 (inclusive) years of age.
- 1) Cognitively Normal Subjects
- 2) MCI subjects
- 3) AD subjects
- 4) vMCI or SIVD
PROCEDURES
- Recruited subjects will have clinical/cognitive assessments, biomarker and genetic sample collection, and imaging.
- Subjects will be followed up for 36 months from the baseline visit. All assessments are to be performed every year from baseline(0, 12, 24, 36 months), except; 1) FDG-PET and amyloid-PET will be performed every two years, i.e., on baseline and at 24 month visit. 2) CSF collection will also be performed on baseline and at 24 months visit. 3) Clinical/cognitive assessment and MRI evaluation will additionally be done at 6 months from baseline to determine short term change.
OUTCOME MEASURES
- Group differences for each clinical, cognitive, biochemical, and imaging measurement.
- Rate of conversion or change of disease severity will be evaluated among all groups
- Correlations among biomarkers and biomarker changes
Read the detailed description
The major goals of K-ADNI are to:
- Establish a registry for Alzheimer's disease (AD) and subcortical ischemic vascular dementia (SIVD)
- Collect longitudinal clinical, imaging, genetic, and biochemical biomarker data for clinical and neuroscience studies on 500 subjects in five diagnostic categories: cognitively normal control (NC), mild cognitive impairment (MCI), mild AD, vascular MCI (vMCI), and SIVD.
- The following measurements known as representative parameters of dementia progress will be included. 1) clinical characteristics, 2) neuropsychological test, 3) structural and functional magnetic resonance image (MRI), 4) Fludeoxyglucose (FDG)-positron emission tomography (PET), 5) amyloid PET (18F-flutemetamol), 6) cerebrospinal fluid (CSF) and blood sample, 7) genetic analysis.
- Determination of factors that are crucial in the aggravation or deterrence of progress of dementia syndrome, so that these factors can be used as predictors and outcome measures of AD and SIVD
- Determine the relationships among clinical, imaging, genetic, and biochemical biomarker characteristics of the entire spectrum of AD, as the pathology evolves from normal aging through very mild symptoms, to MCI, and finally to dementia.
- Also, determine the relationship among clinical, imaging, genetic, and biochemical biomarker characteristics of the vascular MCI (vMCI) and SIVD, which is an important sub-population of dementia syndrome especially in Asian population.
- Identification of surrogate markers for new drug development in patients with AD and SIVD
- Identify prognostic markers of AD and SIVD, identify outcome measures that can be used in clinical trials, and help develop the most effective clinical trial scenarios for new drugs.
- Development of the standard model for acquiring multi-site neuroimaging study data - Develop improved methods which will lead to uniform standards for acquiring longitudinal multi-site clinical, MRI, PET, and other biological markers (blood, CSF, gene) data on patients with AD, MCI, vMCI, SIVD, and elderly controls.
- Keywords
- mild cognitive impairment, Alzheimer's disease, subcortical Vascular Dementia, amyloid, plaques, neuroimaging, biomarkers, cognition disorder, early detection, pre-dementia, dementia, vascular MCI
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia, Vascular, Plaque, Amyloid, Cognition Disorders, Dementia
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 |
|---|---|---|
| cognitively normal | MRI scans, PET scans, lumbar puncture | |
| mild cognitive impairment | MRI scans, PET scans, lumbar puncture | |
| Alzheimer's Disease | MRI scans, PET scans, lumbar puncture | |
| vascular MCI | MRI scans, PET scans, lumbar puncture | |
| subcortical ischemic vascular dementia | MRI scans, PET scans, lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dementia conversion or disease severity worsening, evaluated by neuropsychological, MRI, PET, biomarker indices.
- The rate of decline as measured by clinical dementia rating (CDR) Sum of Boxes
Measured: 0 Months (Baseline), 6 Mos, 12 Mos, 24 Mos, 36 Mos
Secondary outcomes (1)
Change from baseline in cognitive, neuroimaging, and biomarker assessments
- The rate of decline as measured by cognitive tests, Activities of Daily Living
- The rate of volume change of the whole brain, hippocampus, and other structural MRI measures
- Rates of change of glucose metabolism (FDG-PET)
- Extent of amyloid deposition as measured by 18F-flutemetamol
- Correlations among biomarkers and biomarker changes
- Group differences for each imaging and biomarker measurement
Measured: 0 Months (baseline), 6 Mos, 12 Mos, 24 Mos, 36 Mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- 500 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Korean Alzheimers' Disease Neuroimaing Intitiative
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong Yoon Kim, MD, PhD, Korean Alzheimers' Disease Neuroimaing Intitiative
- Investigators
- Seong Yoon Kim, MD, PhD, Principal investigator, Asan Medical Center, Univ. of Ulsan, Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979419
- Sponsor's protocol ID
- HI12C0713
- Acronym
- K-ADNI
- Status last verified
- Mar 2019
- First submitted
- 21 Oct 2013
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korea Alzheimer's Disease Neuroimaging Initiative
- ClinicalTrials.gov ID
- NCT01979419
- Acronym / sponsor ID
- K-ADNI / HI12C0713
- Keywords
- mild cognitive impairment, Alzheimer's disease, subcortical Vascular Dementia, amyloid, plaques, neuroimaging, biomarkers, cognition disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Korean Alzheimers' Disease Neuroimaing IntitiativeUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- 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.
PRIMARY OBJECTIVES
-Establish a registry for Alzheimer's disease (AD) and subcortical ischemic vascular dementia (SIVD)
STUDY DESIGN
-This is a non-randomized, natural history, observational, registry study.
SAMPLE SIZE AND RECRUITMENT
- Five hundred subjects will be enrolled at each clinical site (50 NC, 200 with MCI, 50 with AD, 100 with vMCI, and 100 with SIVD)
SUMMARY OF KEY ELIGIBILITY CRITERIA
- Newly enrolled subjects will be between 50-80 (inclusive) years of age.
- 1) Cognitively Normal Subjects
- 2) MCI subjects
- 3) AD subjects
- 4) vMCI or SIVD
PROCEDURES
- Recruited subjects will have clinical/cognitive assessments, biomarker and genetic sample collection, and imaging.
- Subjects will be followed up for 36 months from the baseline visit. All assessments are to be performed every year from baseline(0, 12, 24, 36 months), except; 1) FDG-PET and amyloid-PET will be performed every two years, i.e., on baseline and at 24 month visit. 2) CSF collection will also be performed on baseline and at 24 months visit. 3) Clinical/cognitive assessment and MRI evaluation will additionally be done at 6 months from baseline to determine short term change.
OUTCOME MEASURES
- Group differences for each clinical, cognitive, biochemical, and imaging measurement.
- Rate of conversion or change of disease severity will be evaluated among all groups
- Correlations among biomarkers and biomarker changes
Detailed description
The major goals of K-ADNI are to:
- Establish a registry for Alzheimer's disease (AD) and subcortical ischemic vascular dementia (SIVD)
- Collect longitudinal clinical, imaging, genetic, and biochemical biomarker data for clinical and neuroscience studies on 500 subjects in five diagnostic categories: cognitively normal control (NC), mild cognitive impairment (MCI), mild AD, vascular MCI (vMCI), and SIVD.
- The following measurements known as representative parameters of dementia progress will be included. 1) clinical characteristics, 2) neuropsychological test, 3) structural and functional magnetic resonance image (MRI), 4) Fludeoxyglucose (FDG)-positron emission tomography (PET), 5) amyloid PET (18F-flutemetamol), 6) cerebrospinal fluid (CSF) and blood sample, 7) genetic analysis.
- Determination of factors that are crucial in the aggravation or deterrence of progress of dementia syndrome, so that these factors can be used as predictors and outcome measures of AD and SIVD
- Determine the relationships among clinical, imaging, genetic, and biochemical biomarker characteristics of the entire spectrum of AD, as the pathology evolves from normal aging through very mild symptoms, to MCI, and finally to dementia.
- Also, determine the relationship among clinical, imaging, genetic, and biochemical biomarker characteristics of the vascular MCI (vMCI) and SIVD, which is an important sub-population of dementia syndrome especially in Asian population.
- Identification of surrogate markers for new drug development in patients with AD and SIVD
- Identify prognostic markers of AD and SIVD, identify outcome measures that can be used in clinical trials, and help develop the most effective clinical trial scenarios for new drugs.
- Development of the standard model for acquiring multi-site neuroimaging study data - Develop improved methods which will lead to uniform standards for acquiring longitudinal multi-site clinical, MRI, PET, and other biological markers (blood, CSF, gene) data on patients with AD, MCI, vMCI, SIVD, and elderly controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| cognitively normal | – | –MRI scans, PET scans, lumbar puncture |
| mild cognitive impairment | – | –MRI scans, PET scans, lumbar puncture |
| Alzheimer's Disease | – | –MRI scans, PET scans, lumbar puncture |
| vascular MCI | – | –MRI scans, PET scans, lumbar puncture |
| subcortical ischemic vascular dementia | – | –MRI scans, PET scans, lumbar puncture |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (18 listed)
- Cognitively Normal Subjects
- MCI subjects
- AD subjects
- vMCI or SIVD
Key exclusion criteria (8 listed)
- Screening/baseline MRI scan with evidence of infection, infarction, or other focal lesions; Participants with multiple lacunes or lacunes in a critical memory structure are excluded
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body
- Major depression, bipolar disorder as described in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) within the past 1 year
- Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder
- History of schizophrenia
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
Rate of dementia conversion or disease severity worsening, evaluated by neuropsychological, MRI, PET, biomarker indices.
Time frame: 0 Months (Baseline), 6 Mos, 12 Mos, 24 Mos, 36 Mos
- The rate of decline as measured by clinical dementia rating (CDR) Sum of Boxes
1 secondary outcome
Change from baseline in cognitive, neuroimaging, and biomarker assessments
Time frame: 0 Months (baseline), 6 Mos, 12 Mos, 24 Mos, 36 Mos
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
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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. This study is not recruiting at the moment.
Seong Yoon Kim, MD, PhD principal investigator
Asan Medical Center, Univ. of Ulsan, Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by Korean Alzheimers' Disease Neuroimaing Intitiative at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of dementia conversion or disease severity worsening, evaluated by neuropsychological, MRI, PET, biomarker indices. (time frame: 0 Months (Baseline), 6 Mos, 12 Mos, 24 Mos, 36 Mos). 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 8 Mar 2019.