Clinical and neuroimaging study on preclinical Alzheimer's disease.
- Conditions
- mild cognitive impairment, preclinical Alzheimer disease
- Registration Number
- JPRN-UMIN000019926
- Lead Sponsor
- Osaka City University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 40
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.