Korea Alzheimer's Disease Neuroimaging Initiative

NCT01979419 | Unknown DMC

• 1 other identifier: HI12C0713
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Mild Cognitive Impairment; Alzheimer's Disease; Subcortical Vascular Dementia

Keywords

mild cognitive impairment; Alzheimer's disease; subcortical Vascular Dementia; amyloid; plaques; neuroimaging; biomarkers; cognition disorder; early detection; pre-dementia; dementia; vascular MCI

Outcome Measures

Primary Outcomes (1)

• 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

  0 Months (Baseline), 6 Mos, 12 Mos, 24 Mos, 36 Mos

Secondary Outcomes (1)

• Change from baseline in cognitive, neuroimaging, and biomarker assessments

  0 Months (baseline), 6 Mos, 12 Mos, 24 Mos, 36 Mos

Study Arms (5)

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

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community Sample

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korean Alzheimers' Disease Neuroimaing Intitiative: lead

Study Sites (1)

Seong Yoon Kim

Seoul, 120752, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Serum, CSF

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia, Vascular; Plaque, Amyloid; Cognition Disorders; Dementia

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Seong Yoon Kim, MD, PhD

  Asan Medical Center, Univ. of Ulsan, Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry, Asan Medical Center

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: November 8, 2013
• Study Start: November 1, 2012
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

KR (1)