KCT0001257Not yet recruiting未知
Korean Alzheimer’s Disease Neuroimaging Initiative
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Asan Medical Center
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational Study
Eligibility Criteria
- Ages
- 50(Year) to 80(Year) (—)
- Sex
- All
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
Investigators
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