Tokyo, May 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061621) titled 'Flutemetamol PET/CT for whoLe-body evalUation of amyloid deposiTion and its systEmic distribution' on May 20.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Kyoto Prefectural University of Medicine

Condition: Condition - Mild Cognitive Impairment and Alzheimer's Disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To exploratorily evaluate the distribution and extent of amyloid deposition in whole-body organs, including the brain, using 18F-flutemetamol PET/CT with additional neck-to-knee imaging beyond standard brain acquisition, and to investigate the association between extracranial amyloid deposition, including gastrointestinal involvement, and cerebral amyloid pathology. Basic objectives2 - Others

Intervention: Interventions/Control_1 - In addition to standard brain 18F-flutemetamol PET/CT imaging, additional neck-to-knee whole-body PET/CT imaging including low-dose CT will be performed for research purposes. The additional acquisition time is approximately 10 minutes to evaluate amyloid uptake in whole-body organs.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Adults aged 20 years or older diagnosed with mild cognitive impairment (MCI) or mild Alzheimer's disease Patients scheduled to undergo clinically indicated 18F-flutemetamol PET/CT at our institution Individuals who provide written informed consent for study participation Key exclusion criteria - Individuals with contraindications to PET examination (e.g., severe allergy history) Individuals unable or unwilling to provide informed consent Minors, pregnant women, or women with possible pregnancy Patients with severe cognitive impairment judged incapable of providing informed consent Individuals considered unsuitable for study participation by the investigator or treating physician Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 25 Day Date of IRB - 2026 Year 04 Month 23 Day Anticipated trial start date - 2026 Year 05 Month 20 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070500

Disclaimer: Curated by HT Syndication.