UMIN-CTR Clinical Trial

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
Email	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
Email	takahata.keisuke@qst.go.jp

Sponsor
Institute	Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology (QST)
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053577