Korean Alzheimer’s Disease Neuroimaging Initiative

Not Applicable

Conditions: Mental and behavioral disorders

Registration Number: KCT0001257

Lead Sponsor: Asan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

The inclusion criteria for this study are as follows

1) Common criteria
?Age between 50 and 80 years old on the first day of the baseline visit.
?At least 6 years of education, and literate.
?Visual and auditory acuity adequate for neuropsychological testing.
?Geriatric Depression Scale less than 6 and no evidence of depression.
?Willing to undergo repeated Magnetic Resonance Imaging (MRI) and at least 2 Positron Emission Tomography (PET) scans and no medical contraindications to MRI
?Agrees to lumbar puncture and neuropsychological testing
Visiting with a study partner who has frequent contact with the subject (e.g. an average of 2 hours per day or more), and can accompany the subject to all clinic visits for the duration of the protocol is recommended.
?NO significant change in medication within 3 months of screening.
2) Cognitively normal (CN)
?Satisfies common criteria
?Free of memory complaints..
?Delayed recall subscores of the Seoul Verbal Learning Test, controlled for level of education and age, above -1.0 SD(Standard Deviation)
?Mini Mental Status Examination(K-MMSE) score controlled for level of education and age, above -1.5 SD(Standard Deviation)
?Clinical Dementia Rating scale(CDR) and memory box score both 0.
?Cognitively normal based on an absence of significant impairment in cognitive functions or activities of daily living.
3) Mild cognitive impairment (MCI)
?Satisfies common criteria
?Subjective memory concern reported by subject and caregiver
?Delayed recall subscores of the Seoul Verbal Learning Test, controlled for level of education and age, below -1.0 SD(Standard Deviation). (Early MCI: -1.5 ~ -1.0 SD(Standard Deviation), Late MCI: < -1.5 SD(Standard Deviation))
?Mini Mental Status Examination(K-MMSE)score controlled for level of education and age, above -1.5 SD(Standard Deviation).
?Clinical Dementia Rating scale(CDR) and memory box score both 0.5.
?Absence of significant impairment in activities of daily living.
4) Alzheimer’s disease (AD)
?Satisfies common criteria
?Subjective and objective memory concern reported by subject and caregiver .
?Delayed recall subscores of the Seoul Verbal Learning Test, controlled for level of education and age, below -1.5 SD(Standard Deviation).
?Mini Mental Status Examination(K-MMSE)score controlled for level of education and age, below -1.0 SD(Standard Deviation).
?Clinical Dementia Rating scale(CDR) 0.5 or 1.
?Probable AD by the National Institute of Neurological and Communicative Disorders and Stroke / the Alzheimer's disease and related Disorders Association (NINCDS/ADRDA) criteria.
5) Subcortical Ischemic Vascular Dementia (SIVD)
?Satisfies common criteria.
?All of the following
A. At least 2 of the following vascular risk factors within 5 years
- Hypertension, Diabetes, hyperlipidemia, smoking, obesity (Body Mass Index, BMI > 25.0)
B. Documented history of more than 1 focal neurologic symptom, sign
C. White matter hyperintensities, above moderate severity, on MRI images
?Delayed recall subscores of the Seoul Verbal Learning Test, controlled for level of education and age, below -1.5 SD(Standard Deviation).
?Mini Mental Status Examination(K-MMSE)score controlled for level of education and age, below -1.0 SD(Standard Deviation).
?Clinical Dementia Rating scale(CDR) 0.5 or 1.

Exclusion Criteria

?Previous or current diagnosis of:
A.Major neurodegenerative disease such as Parkinson’s disease
B.Vascular dementias not included in the diagnostic categories, such as multi-infarct dementia, strategic-infarct dementia
C.Brain lesions with focal neurologic deficits. (e.g., Huntington’s disease, Normal pressure hydrocepalus, Brain tumor, Progressive supranuclear palsy)
D.Seizure disorders that may cause generalized tonic-clonic seizures
E.Diseases or disorders that may cause secondary cognitive impairment
?Subjects wiith focal lesions suggestive of infection or infarction on brain MRI. Subjects with < 5 lacunae may participate
?Major psychiatric disorder, such as schizophrenia, major depressive disorder or bipolar disorder within the past 2 years
?Uncontrolled sleeping, anxiety or behavioral disorder within 3 months
?Alcohol or substance dependence within the past 2 years
?Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
F.Malignant tumor within the past 3 years. Subjects with curable tumors and thyroid cancer, as well as other mild tumors the investigator deems mild may participate. Subjects in remission may also participate.
G.Medical illnesses that may cause psychiatric disorders. To be considered on a case-by-case basis at the discretion of the investigator.
?Current use of specific psychoactive medications (e.g., certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.).
?Subject is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).
?Investigational agents are prohibited one month prior to entry and for the duration of the trial.
?Subject unable for PET scan. This may include, but is not limited to the following:
A.Claustrophobic, subjects unable to maintain supine position for more than 40 minutes.
B.Previous adverse event to 18F-flutemetamol or related substances such as polysorbate 80