The study analyzing blood and cerebrospinal fluids from the patients with early onset Alzheimer disease to discover causative factors and biomarkers
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0000847
- Lead Sponsor
- Soon Chun Hyang University Hospital Bucheon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 516
1)Disease group: The patients who develop AD or MCI before 65 year-old
2)Control 1 (normal control or first degree family member of AD patient ): The normal persons who have normal neuroimaging (on Brain CT or Brain MRI) and cognitive functions or the first degree senior family member of AD patients.
3)Control 2 (sporadic AD senile patients): The patients who develop AD after 65 year-old, but do not have first degree family history of AD.
Alzheimer's disease is diagnosed based on the followings,
1) Dementia by DSM-IV
2) Probable AD by NINCDS-ADRDA
3) Slowly progressive cognitive decline, at least for 6 months
4) Presence of one of the followings according to the revised NINCDS-ADRDA criteria
?Atrophy of medial temporal and/or parietal lobe on MRI,
?Hypometabolism in medial temporal and/or parietal lobe on FDG-PET, or increased uptake in the same area on amyloid PET
MCI is diagnosed based on the followings,
1) No dementia or normal
2) Memory complaint by subject or study partner
3) Objective cognitive impairment
4) Preserved activities of daily living
Normal is diagnosed based on the followings,
1)No dementia or MCI
2)No significant brain atrophy or other abnormalities in CT or MRI
1) Blindness or hearing loss to be unable to be tested
2)sick-sinus syndrome, a second or third degree atrioventricular block
3)severe pulmonary disease (acute, severe, or unstable asthma, severe COPD)
4)an active gastric ulcer
5)uncontrolled diabetes mellitus
6)severe hepatic, or renal disease
7)uncured malignancy
8)major depressive disorder, psychosis
9)mental retardation
10)a history of encephalitis
11)head trauma with loss of consciousness longer than one hour
12)a brain tumor, a traumatic intracranial hemorrhage or a subarachnoid hemorrhage
13) abnormal TFT
14) a deficiency in vitamin B12 or folate
15) neurosyphilis
16)metabolic encephalopathy
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The validity of genetic or protein markers in predicting AD development or its prognosis.
- Secondary Outcome Measures
Name Time Method The corrrelations with the known risk genes and biomarkers