Mild cognitive impairment, Healthy volunteer
Conditions
Interventions
PET/MRI/psychological batteries/neurological examinations
Sponsors
National Institutes for Quantum and Radiological Science and Technology
AJINOMOTO CO., INC. Research Institute for Bioscience Products &
Fine Chemicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Case group (1) A person who is at least 20 years old at the time of obtaining consent. (2) A person whom a potential substitute can accompany on the day of participation in the study at NIRS. (3) Patients with MCI: Patients who meet Petersen's diagnostic criteria (not having dementia is included in the criteria). (4) Patients who meet the criteria for screening by neuropsychological examination. Mini-Mental State Examination (MMSE) score of 24 or higher, global Clinical Dementia Rating Scale (CDR) score of 0.5, Geriatric Depressive Scale (GDS) score of 5 or lower. Healthy volunteers (1) Healthy volunteers who are 20 years old or older at the time of obtaining consent. (2) A healthy person who can give consent to participate in this study and who can read and understand the consent document. (3) Those who meet the criteria for neuropsychological screening. MMSE 28 points or higher, global CDR 0 points, GDS 5 points or lower.
Exclusion criteria
Exclusion criteria: (1) Patients with a history of or complications from organic brain disease. (2) Patients with substance-related disorders. (3) Those who have been diagnosed with cancer or liver cirrhosis within the past 5 years. (4) Dialysis patients. (5) Those who have complications from serious diseases, or those who have a history of such complications. (6) Patients with pacemakers or internal metals. (7) Those who have tattoos. (8) Those who are claustrophobic. (9) Those who are pregnant or may be pregnant, and those who are breast-feeding. (10) Those who have participated in other examinations involving radiation exposure within the past 6 months. (11) Those who are participating in other clinical trials, including clinical trials, research to which the Clinical Research Act applies, and research to which the Ethical Guidelines for Medical and Health Research Involving Human Subjects. (12) Those who have donated blood within 3 months of the time of donation. (13) Those who are allergic to local anesthetics and blood coagulation inhibitors. (14) Those who are taking anticoagulant drugs. (15) Those who are taking anti-dementia drugs (including investigational drugs) or have stopped taking them within 4 weeks. (Case group only) (16) Those who are taking psychotropic drugs regularly. (Case group only) (17) Those who are taking the following drugs, supplements, or health foods at least once a day. (a) Amino acid preparations (b) Amino acid/protein supplements (c) Amino acid beverages (d) Supplements and health foods that may affect cognitive function (18) Those who have consumed food, medication, supplements, or health foods as specified in (17) from 10 hours before blood test collection for physical condition check, blood amino acid analysis, and blood biomarker analysis to just before blood collection. (19) Those who have been educated in schools for 6 years or less. (20) Those who are judged to be inappropriate as research participants by the researcher doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group differences in brain monoamine oxidase-beta assessed by PET scan using [11C]SL25.1188 in individuals with mild cognitive impairment and healthy volunteers. The relationship between brain monoamine oxidase-beta assessed by PET scan using [11C]SL25.1188 in individuals with mild cognitive impairment and healthy volunteers. [11C]SL25.1188 PET scans in healthy volunteers and those with mild cognitive impairment, and the relationship between brain monoamine oxidase-beta assessed by MRI and abnormal protein accumulation assessed by PET. | — |
Secondary
| Measure | Time frame |
|---|---|
| Association between brain monoamine oxidase-beta assessed by PET scan using [11C]SL25.1188 and brain neurotransmitters and blood biomarkers assessed by MRS in individuals with mild cognitive impairment and healthy volunteers | — |
Countries
Japan
Contacts
Public ContactShizuko Kawakami
National Institutes for Quantum and Radiological Science and Technology Clinical Research Support Section, National Institute of Radiological Sciences
Outcome results
None listed