Amyloid Brain PET study

JRCT ID: jRCTs032230491

Registered date:04/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dementia
• Date of first enrollment: 04/12/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Performing PET imaging after administration of radiopharmaceuticals (approved drugs)

Outcome(s)

Primary Outcome

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.

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

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Takahashi Miwako
• Secondary Sponsor: Yamaya Taiga
• Source(s) of Monetary Support: ATOX CO., LTD.