None listed
Conditions
Interventions
None listed
Sponsors
Gachon University Gil Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: cognitive normal (unimpaired), mild cognitive impairment and dementia [CN(CU)] Cognitive performance within expected range for that individual based on all available information. This may be based on clinical judgment and/or on cognitive test performance (which may or may not be based on comparison to normative data, with or without adjustments for age, education, occupation, sex, etc.). Cognitive performance may be in the impaired/abnormal range based on population norms, but performance is within the range expected for that individual. A subset of cognitively unimpaired individuals may report subjective cognitive decline and/or demonstrate subtle decline on serial cognitive testing. [MCI] Cognitive performance below expected range for that individual based on all available information. This may be based on clinical judgment and/or on cognitive test performance (which may or may not be based on comparison to normative data with or without adjustments for age, education, occupation, sex, etc.). Cognitive performance is usually in the impaired/abnormal range based on population norms, but this is not required as long as the performence is below the range expected for that individual. Inaddition to evidence of cognitive impairment, evidence of decline in cognitive performance from baseline must also be present. This may be reported by the individual or by an observer (e.g., study pertner) or observed by change on lognitudinal cognitive testing/behavioral assessments or by a combination of these. May be characterized by cognitive presentations that are not primarily amnestic. Although cognitive impairment is the core clinical criteria, neurobehavioral disturbance may be a prominent feature of the clinical presentation. Performs daily life activities independently, but cognitive difficulty may result in detectable but mild functional impact on the more complex avtivities of daily life, either self-reported or corroborated by a study partner [Dementia] Substantial progressive cognitive impairment that affects several domains and/or neurobehavioral symptoms. May be reported by the individual or by an observer (e.g., study partner) or observed by change on longitudinal cognitive testing. Cognitive impairment and/or neurobehavioral symptoms result in clearly evident functional impact on daily life. No longer fully independent/requires assistance with daily life activities. This is the primary feature differentiating dementia from MCI. May be subdivided into mild, moderate, and severe
Exclusion criteria
Exclusion criteria: ? Pregnant women (screen by questionnaire and last menstrual period; any suspicion leads to exclusion) ? Currently breastfeeding ? Systemically too ill to undergo study procedures ? Claustrophobia or seizure disorders (e.g., epilepsy) ? Definite dementia due to other causes or major neurological disease (e.g., traumatic brain injury, Parkinson’s disease, Huntington’s disease, motor neuron disease, multiple sclerosis) ? Prior stroke involving cerebrum/brainstem/cerebellum (exclude only if deemed impactful by the investigator) ? Psychiatric disorders such as schizophrenia ? Brain tumor, hydrocephalus, encephalitis, metabolic encephalopathy ? For women: current pregnancy or intrauterine contraceptive device in situ ? Any other condition judged unsuitable by the clinical investigator ? Implanted pacemaker or metallic implants (exceptions: titanium/titanium alloy implants or specialist cleared devices for 3T MRI) ? Intracranial metal (e.g., vascular clips, orthodontic appliances) likely to distort MRI ? Cumulative effective dose > 50 mSv within the past year (e.g., =2 PET scans, coronary angiography, or abdomino pelvic CT) or occupational high radiation exposure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain MRI-Based Evaluation of Neurofluid Activity;Amyloid PET-based evaluation of amyloid burden;Tau PET-based evaluation of tau burden | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma biomarkers related to dementia risk factors and biomarker(amyloid beta, tau etc.);Standardized evaluation of memory, attention, language ability, visuospatial functions, and executive function, based on normative data;Measurement of cerebral blood flow dynamics, Assessment of microvascular elasticity index (MRIR);Physical activity & functional performance and muscle strength assessments | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Noh
Gachon University Gil Medical Center
Outcome results
None listed