臨床研究等提出・公開システム

Exploratory Study of Brain Functional Changes by High-Resolution Brain PET

Brain functional study with Brain PET

Takahashi Miwako

National Institutes for Quantum Science and Technology

4-9-1 Anagawa Inage-ku Chiba-shi Chiba

takahashi.miwako@qst.go.jp

Takahashi Miwako

National Institutes for Quantum Science and Technology

4-9-1 Anagawa Inage-ku Chiba-shi Chiba

+81-43-206-4074

takahashi.miwako@qst.go.jp

Recruiting

July. 10, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

Healthy volunteers
1 Individuals who voluntarily apply to participate and whom the principal investigator or sub-investigator determines to be capable of understanding the contents of the informed consent document.

Patients suspected of having cognitive disorders
1 Individuals who voluntarily apply to participate and whom the principal investigator or sub investigators determine to be capable of understanding the contents of the informed consent document.
2 Patients suspected of having cognitive disorders, including cases suspected of having Alzheimer's disease dementia or front-temporal dementia based on examination by the attending physician.

1 Individuals with hypersensitivity to alcohol.
2 Individuals with serious complications or a history of serious illness or surgery.
3 Individuals currently taking narcotics or psychotropic drugs.
4 Individuals with a fasting blood glucose level of 150 mg/dL or higher, or with diabetes mellitus of equivalent severity.
5 Individuals with severe claustrophobia that would make MRI or PET imaging difficult.
6 Individuals for whom head MRI examination is difficult due to tattoos (including cosmetic tattoos/permanent makeup), a pacemaker, cochlear implant, or other similar devices or conditions.
7 Individuals who are pregnant, may be pregnant, or are breastfeeding.
8 Individuals who are otherwise considered unsuitable for participation by the principal investigator or sub-investigators.
9 Individuals who have participated in any other clinical study involving radiopharmaceuticals, except for the "Amyloid distribution study by high spec brain-dedicated PET " (jRCTs032230491).

Both

Cognition disorders

Performing PET imaging after administration of radiopharmaceuticals (approved drugs and an unproved drug)

Cognition disorders, Dementia

Positron-Emission Tomography

D060825

D049268

To explore visual changes on brain glucose metabolism PET, amyloid PET, and tau PET images obtained using a dedicated brain PET scanner in patients suspected of having cognition disorders, in comparison with healthy volunteers, and to evaluate whether such changes may serve as early findings of higher brain dysfunction.

1 If visually altered regions are identified on dedicated brain PET images of patients suspected of having cognition disorders, to clarify the relationship between quantitative indices of the altered regions (standardized uptake value [SUV]) and indicators of disease severity obtained as clinical information.
2 To compare dedicated brain PET images before and after motion correction, as well as motion-corrected dedicated brain PET images with conventional PET images, in order to clarify whether there are differences in visual assessment and differences in quantitative indices (SUV).

+81-43-206-4706

June. 26, 2026

Yes

Upon request at the time deemed necessary, anonymized individual participant data will be provided to applicants (research institutions or companies in Japan or overseas) based on agreement among the coordinating administrator, the researchers sharing the intellectual property, and the representative of ATOX Co., Ltd..

none