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Japanese

Dec. 04, 2023

Mar. 05, 2025

jRCTs032230491

Amyloid distribution study by high spec brain-dedicated PET

Amyloid Brain PET study

Takahashi Miwako

National Institutes for Quantum Science and Technology

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

+81-43-206-4074

takahashi.miwako@qst.go.jp

Takahashi Miwako

National Institutes for Quantum Science and Technology

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

+81-43-206-4074

takahashi.miwako@qst.go.jp

Recruiting

Dec. 04, 2023

Mar. 28, 2024
20

Interventional

single arm study

open(masking not used)

active control

single assignment

diagnostic purpose

1. Patients who complained of subjective cognitive decline and was suspected to be in the early stages of Alzheimer's disease according to the symptoms.
2. Age at the time of informed consent is 40 to 80 years old, regardless of gender.
3. Patients who had a score of 24 points or higher on MMSE conducted within 6 months before consent was obtained.
4. Patients who are judged by the principal investigator to be capable of understanding the study explanation and consent document.

1. History of hypersensitivity to alcohol.
2. History of serious complications, medical or surgery.
3. Patients currently taking medications; narcotics, psychotropic drugs, or anti-Parkinson's drugs.
4. Taking medications for diabetes mellitus.
5. Claustrophobia.
6. People who have difficulty undergoing head MRI due to tattoos (including tattoos and permanent makeup), pacemakers, cochlear implants, etc.
7.Patients who are pregnant or may be pregnant, or who are breastfeeding.
8.Patient who is judged to be inappropriate as a participant by the principal or collaborating doctors

40age old over
80age old under

Both

Dementia

Performing PET imaging after administration of radiopharmaceuticals (approved drugs)

D003704

1. Comparison of mean cortical SUVR of amyloid PET using a brain-dedicated PET and a whole-body PET
2. Characteristics of Abeta and FDG brain distribution in amyloid PET positive cases.

Abeta mean cortical SUVR by Amyloid PET, FDG SUV by FDG-PET for each brain region.

ATOX CO., LTD.
Not applicable
National Institutes for Quantum Science and Technology Certified Review Board
4-9-1 Anagawa Inage-ku Chiba-shi, Chiba

+81-43-206-4706

helsinki@qst.go.jp
Approval

Nov. 27, 2023

Yes

After publication of this study, de-identified (anonymized) or coded (pseudonymized) individual clinical trial participant data would be shared when needed, upon request from a third party including domestic, oversea researchers, doctors, and company, authorized by the principal doctor, researchers sharing patents with ATOX CO., LTD, and ATOX CO., LTD person in charge.

none

History of Changes

No Publication date
5 Mar. 05, 2025 (this page) Changes
4 April. 08, 2024 Detail Changes
3 Mar. 29, 2024 Detail Changes
2 Mar. 08, 2024 Detail Changes
1 Dec. 04, 2023 Detail