Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059577) titled 'PET studies on synaptic function alterations in neurological disorders' on Dec. 1.

Study Type: Interventional

Study Design: Basic Design - Factorial Randomization - Non-randomized Blinding - Open -no one is blinded Control - Placebo

Primary Sponsor: Institute - The University of Osaka

Condition: Condition - Healthy subjects, and patients diagnosed with occlusion or stenosis of the major cerebral arteries, neuroinflammatory disorders, neurodegenerative disorders, vascular dementia, and epilepsy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim is to evaluate changes in the pathology and pathophysiology of cerebrovascular disorders, neuroinflammatory diseases, and neurodegenerative diseases with respect to synaptic function. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Subjects shall have an intravenous access route established in an upper limb vein using either a hypodermic needle or an indwelling needle, and receive a single intravenous dose of [18F]SynVesT-1 at 3.7 MBq/kg (minimum dose 111 MBq, maximum dose 370 MBq). Interventions/Control_2 - Head PET imaging is performed for approximately 20 minutes, commencing 60 minutes after administration.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Individuals from whom written consent for study participation has been obtained Healthy subjects aged 20 to 60 years without brain or neurological disorders Key exclusion criteria - Pregnant or breastfeeding individuals Individuals with gross organic brain abnormalities Other individuals deemed unsuitable by the principal investigator or co-investigators Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 20 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2027 Year 03 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068126

Disclaimer: Curated by HT Syndication.