mild cognitive impairment, preclinical Alzheimer disease
Conditions
Interventions
None listed
Sponsors
J-ADNI2 study group
Research Association for Biotechnology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Preclinical AD study: 150 amyloid PET-positive and 150 amyloid PET-negative cognitively normal individuals, whose language is Japanese. In addition, participants in J-ADNI1 as cognitively normal, who had completed 3-year longitudinal study and were amyloid PET-positive or low CSF Abeta(1-42) (n=~20), will be asked about their willingness to further participate in J-ADNI2. 2. MCI study: 100 late MCI and 100 early MCI individuals who meet with the criteria of each type of MCI (below).In addition, participants in J-ADNI1 as (late) MCI, who had completed 3-year longitudinal study and were amyloid PET-positive or low CSF Abeta(1-42) (n=~20), will be asked about their willingness to further participate in J-ADNI2. 3. Living at home, accompanied by a study partner who has a direct contact with the participant >10 hr per week. The participant should be accompanied by the study partner at every visit throughout the study. 4.The participants and study partners should sign agreement forms. 5. Age: 65-84 years (preclinical AD study) and 60-84 years (MCI study) upon enrollment. Individuals of both sexes will be enrolled. 6a. Criteria for participants in preclinical AD study MMSE: 24-30 Scores of Wechsler memory Scale-R logical memory II (corrected for education), above the cut-off levels. education 0-7 years: 3 or above 8-15 years: 5 or above >16 years 9 or above CDR 0, not depressed Individuals who are amyloid PET-positive upon screen scan are categorized as "preclinical AD" and amyloid PET-negative as "normal aged". 6b. Criteria for amnestic MCI Memory disturbance approved by the participant or study partner or clinician. MMSE: 24-30 Scores of Wechsler memory Scale-R logical memory II (corrected for education), below the cut-off levels. education 0-7 years: 2 or lower (late MCI); 3-6 (early MCI) 10-15 years: 4 or lower (late MCI); 5-9 (early MCI) >16 years 8 or lower (late MCI); 9-11 (early MCI) CDR 0.5 not depressed
Exclusion criteria
Exclusion criteria: 1. Parkinson' disease, Lewy body dementia, frontotemporal dementia, Huntington's disease, progressive supranuclear palsy or other neurodegenerative diseases other than AD. Multiple cerebral infarction, normal pressure hydrocephalus, brain tumor, epilepsy, subdural hematoma, multiple sclerosis, head trauma with sequelae will also be excluded. 2. Signs of brain infection, focal brain lesions (eg infarction) that may affect cognitive function. Individuals with subcortical small infarction or diffuse white matter lesions can be included except for those in specific lesions affecting cognition. Cortical infarcts are normally excluded. 3. Presence of pacemaker, arterial clip, artificial valves, artificial cochlea, and other magnetic/electroconductive metals in the body that may affect MRI scan. 4. Major depression or bipolar disorder within past 1 year, past history of schizophrenia, defined by DSM-IV. 5. Addiction to alcohol or other drugs within past 2 years. 6. Past history of psychiatric symptoms, agitation or abnormal behaviors that affect protocol adherence within past 3 months. 7. Presence of fatal or unstable diseases. 8. Vitamin B12 or folate deficiency, syphilis, thyroid function abnormality. 9. Admission to care home or hospitals. 10. Administration of specific drugs (defined in J-ADNI2 procedure manual) including psychoactive drugs and warfarin. 11. Administration of any drugs in clinical trial within 1 month prior to screening. 12. Participation in clinical studies or clinical trials other than J-ADNI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) preclinical AD study: progression rate to CDR 0.5 (MCI) stage in amyloid PET positive or negative groups (2) MCI study: progression rate (conversion) to dementia in amyloid PET positive or negative groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of change in MRI brain morphometry, uptake in FDG-PET in amyloid PET positive or negative groups, cognitive tests, and their correlation with cerebrospinal fluid biomarkers and apoE genotype | — |
Countries
Japan
Contacts
Public ContactTakeshi Iwatsubo
Data Center of J-ADNI Clinical Research Support Center, The University of Tokyo
Outcome results
None listed