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Korea Alzheimer's Disease Neuroimaging Initiative

NCT01979419 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2019-03-08

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • Korean Alzheimers' Disease Neuroimaing Intitiative

    lead OTHER

Principal Investigators

  • Seong Yoon Kim, MD, PhD · Asan Medical Center, Univ. of Ulsan, Medical College

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01979419 on ClinicalTrials.gov