Korea Alzheimer's Disease Neuroimaging Initiative — K-ADNI  

Mild Cognitive Impairment Clinical Trial

Official title: Korea Alzheimer's Disease Neuroimaging Initiative

Status Active, not recruiting

Clinical 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.

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

Clinical Trial Description

The major goals of K-ADNI are to:

1. 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.

2. 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.

3. 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.

4. 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. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognitive Dysfunction
• Dementia
• Dementia, Vascular
• Mild Cognitive Impairment
• Subcortical Vascular Dementia

• NCT number: NCT01979419
• Study type: Observational [Patient Registry]
• Source: Korean Alzheimers' Disease Neuroimaing Intitiative
• Status: Active, not recruiting
• Start date: November 2012
• Completion date: October 2020