UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043458 |
|---|---|
| Receipt number | R000049626 |
| Scientific Title | The investigation of changes in brain monoamine oxidase-B and their relation to pathologies in mild cognitive impairment |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2023/04/10 10:00:08 |
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Basic information
Public title
The investigation of changes in brain monoamine oxidase-B and their relation to pathologies in mild cognitive impairment
Acronym
The investigation of changes in brain monoamine oxidase-B and their relation to pathologies in mild cognitive impairment
Scientific Title
The investigation of changes in brain monoamine oxidase-B and their relation to pathologies in mild cognitive impairment
Scientific Title:Acronym
The investigation of changes in brain monoamine oxidase-B and their relation to pathologies in mild cognitive impairment
Region
| Japan |
Condition
Condition
Mild cognitive impairment, Healthy volunteer
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Quantitative measurement of monoamine oxidase-B in the brain of patients with mild cognitive impairment, and search for relationships between blood data such as amino acids, accumulation of amyloid-beta and tau protein associated with Alzheimer's disease pathology, brain morphology and function, neurotransmission function, and clinical symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
PET/MRI/psychological batteries/neurological
examinations
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kiwamu |
| Middle name | |
| Last name | Matsuoka |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Department of Functional Brain Imaging Research, National Institute of Radiological Sciences
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
+81-43-206-3251
matsuoka.kiwamu@qst.go.jp
Public contact
Name of contact person
| 1st name | Shizuko |
| Middle name | |
| Last name | Kawakami |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Clinical Research Support Section, National Institute of Radiological Sciences
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
+81-43-206-3251
Homepage URL
kawakami.shizuko@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO CO., INC.
Research Institute for Bioscience Products & Fine Chemicals
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
AJINOMOTO CO., INC.
Research Institute for Bioscience Products & Fine Chemicals
Name of secondary funder(s)
AJINOMOTO CO., INC.
Research Institute for Bioscience Products & Fine Chemicals
IRB Contact (For public release)
Organization
Certified Review Board
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
Tel
+81-43-206-4709
helsinki@qst.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 27 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049626
