mild cognitive impairment, preclinical Alzheimer disease
Conditions
Interventions
Neuroimaging study using PET diagnostics not yet approved for diagnostic indications (brain PET scan using 11C-PiB, florbetapir or flutemetamol at 0 and 36 months)
Sponsors
Osaka City University
Osaka city university hospital and 35 hospitals in Japan
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. 2. MCI study: 100 late MCI and 100 early MCI individuals who meet with the criteria of each type of MCI (below). 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: 65-85 years (preclinical AD study) and 60-85 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 the 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 AMED preclinical. 13. Probable participation in clinical trials for Alzheimer's disease drugs during the study duration of 3 years. 14. Decision of exclusion otherwise judged by site study physician or clinical core.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive assessments, brain imaging, and biomarkers in cerebrospinal fluid, and estimation of conversion rate from asymptomatic preclinical AD to MCI and further to AD dementia. | — |
Secondary
| Measure | Time frame |
|---|---|
| The evaluation of correlation among indexes such as amyloid-PET, neuropsychometry, brain imaging, and biomarkers in cerebrospinal fluid. Genetic analysis of APP, presenilin (PSEN 1,PSEN 2) and related genes (MAPT,PGRNetc.), and comparison between the phenotype (symptoms) and the genotype of whole genome. | — |
Countries
Japan
Contacts
Public ContactHiroyuki Shimada
Graduate School of medicine, Osaka City Nuversity Center for Clinical study on dementia
Outcome results
None listed