Alzheimer'
Conditions
Interventions
None listed
Sponsors
J-ADNI study group
Research association for Biotechnology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 150 cases of normal aged individuals, 300 cases of MCI, 150 cases of early AD, whose language is Japanese. Living at home, accompanied by a study partner. The participants should sign agreement forms. In case the participant is not capable of agreeing, the study partner should sign in substitution. Age: 60-84 years upon enrollment Criteria for normal aged individuals MMSE: 24-30 Scores of Wechsler memory Scale-R logical memory II (corrected for education), above the cut-off levels. education 0-9 years: 3 or above 10-15 years: 5 or above >16 years 9 or above Criteria for amnestic MCI Type 1: complaint of memory disturbance from the participant plus approval by the study partner Type 2: memory disturbance approved by the study partner, without the subjective complaint of the participant (excluded in case only with subjective memory complaint, without approval by the study partner) MMSE: 24-30 Scores of Wechsler memory Scale-R logical memory II (corrected for education), below the cut-off levels. education 0-9 years: 2 or lower 10-15 years: 4 or lower >16 years 8 or lower CDR 0.5 not depressed Criteria for early AD MMSE: 20-26 Scores of Wechsler memory Scale-R logical memory II (corrected for education), below the cut-off levels. education 0-9 years: 2 or lower 10-15 years: 4 or lower >16 years 8 or lower CDR 0.5 or 1 Probable AD by the criteria of NINCDS-ADRDA (Causes or diseases leading to dementia other than AD excluded)
Exclusion criteria
Exclusion criteria: 1. Parkinson' disease, multiple cerebral infarction, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, head trauma with sequelae 2. Signs of brain infection, focal brain lesions (eg infarction) that may affect cognitive function. 3. Presence of pacemaker, arterial clip, artificial valves, artificial cochlea, and other magnetic/electroconductive metals in the body that may affect MRI 4. Major depression or bipolar disorder within past 1 year, addiction to alcohol or other drugs within past 2 years, presence of fatal or unstable diseases, vitamin B12 or folate deficiency, syphilis, thyroid function abnormality 5. administration of psychoactive drugs (defined in procedure manual) 6. administration of warfarin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical/neuropsychological examinations: CDR, MMSEm WMS-R logical memory I & II, ADAS-Cog, clock drawing/copying, symbol, block design, digit span, knowledge, fluency, trail making test A & B, Boston naming test, geriatric depression scale, Neuropsychiatric Inventory Q, FUnctional activity questionnaire Magnetic Resonance Imaging of brain: 1.5 tesla MRI in all cases, 3 tesla in 25% of cases Positron Emission Tomogram: fluorodeoxy glucose PET in 50% of cases Lumbar puncture: in 50% cases at baseline and 12 months blood and urine collection in all cases amyloid PET imaging (25% cases) | — |
Countries
Japan
Contacts
Public ContactTakeshi Iwatsubo
administration office of J-ADNI office of clinical study administration
Outcome results
None listed