UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046956 |
|---|---|
| Receipt number | R000053577 |
| Scientific Title | PET study using [11C]K-2 on the relationship between AMPA receptor and tau accumulation in Alzheimer's disease and related diseases |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/03/10 10:58:09 |
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Basic information
Public title
PET study using [11C]K-2 on the relationship between AMPA receptor and tau accumulation in Alzheimer's disease and related diseases
Acronym
PET study using [11C]K-2 on the relationship between AMPA receptor and tau accumulation in Alzheimer's disease and related diseases
Scientific Title
PET study using [11C]K-2 on the relationship between AMPA receptor and tau accumulation in Alzheimer's disease and related diseases
Scientific Title:Acronym
PET study using [11C]K-2 on the relationship between AMPA receptor and tau accumulation in Alzheimer's disease and related diseases
Region
| Japan |
Condition
Condition
Alzheimer's disease,Mild cognitive impairment(MCI)
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to measure AMPA receptors in the brain in Alzheimer's disease and related disorders by performing positron emission tomography (PET) and tau-amyloid PET scans using [11C]K-2 over time.
Basic objectives2
Others
Basic objectives -Others
To elucidate the relationship between AMPA receptors and protein storage disease, neurotransmitters, and clinical symptoms.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative evaluation of the distribution of [11C]K-2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
PET with 18F-PMPBB3 / Neurops ychological tests
Interventions/Control_2
PET with 18F-PMPBB3 / Neurops ychological tests
Interventions/Control_3
PET with 18F-PMPBB3 / Neurops ychological tests
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
Patients diagnosed with MCI or AD
The diagnostic criteria for each disease shall be as follows.
1) MCI: Patients who meet the diagnostic criteria of Petersen
(2) AD: Patients who meet the diagnostic criteria of NINCDS-ADRDA
Healthy volunteer group
1) Those who have the ability to give consent to participate in this study, and who can read and understand the consent explanatory document.
Key exclusion criteria
Patients diagnosed with MCI or AD
1) Patients with a history of or complications from organic brain disease (disorders of consciousness, head trauma requiring hospitalization, obvious cerebral infarction or cerebral hemorrhage, etc.)
(2) Those who have substance-related disorders (e.g., drug dependence).
(3) Those who have complications from serious diseases, or those who have a history of such complications and are judged by the physician as the researcher to be inappropriate for this research.
(4) Those with pacemakers or internal metal devices (brain clips, bolts, etc.)
(5) Those with tattoos (including tattoos and art makeup)
(6) Those who are highly claustrophobic
(7) Patients who are pregnant or may be pregnant, and those who are breastfeeding
(8) Others who are judged inappropriate as research subjects by the researcher's physician.
Healthy volunteer group
1) Subjects with a history of or complications from organic brain disease (disorders of consciousness, head trauma requiring hospitalization, obvious cerebral infarction or cerebral hemorrhage, etc.)
(2) Those who have substance-related disorders (e.g., drug dependence).
(3) Those who have complications from serious diseases, or those who have a history of such complications and are judged by the physician as the researcher to be inappropriate for this research.
(4) Those with pacemakers or internal metal devices (brain clips, bolts, etc.)
(5) Those with tattoos (including tattoos and art makeup)
(6) Those who are highly claustrophobic
(7) Patients who are pregnant or may be pregnant, and those who are breastfeeding
(8) Subjects who are judged inappropriate as research subjects by the researcher's physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Takahata |
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology (QST)
Division name
Department of Functional Brain Imaging
Zip code
263-8555
Address
4-9-1 Anagawa, Inage, Chiba, Chiba, Japan
TEL
043-206-3251
takahata.keisuke@qst.go.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Takahata |
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, QST
Division name
Department of Functional Brain Imaging
Zip code
263-8555
Address
4-9-1 Anagawa, Inage, Chiba, Chiba, Japan
TEL
043-206-3251
Homepage URL
takahata.keisuke@qst.go.jp
Sponsor or person
Institute
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology (QST)
Institute
Department
Personal name
Funding Source
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology (QST)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, QST
Address
4-9-1 Anagawa, Inage, Chiba, Chi ba, Japan
Tel
0432063025
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
| 2022 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 02 | Month | 20 | Day |
Last modified on
| 2022 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053577
