Tokyo, April 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061168) titled 'Longitudinal study of brain synaptic function and symptom changes in neurological and psychiatric disorders' on April 6.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - National Institutes for Quantum Science and Technology, Institute for Quantum Medical Science

Condition: Condition - Dementia-related disorders: Mild cognitive impairment (MCI), Alzheimer's disease (AD), Frontotemporal lobar degeneration, Chronic traumatic encephalopathy (CTE) Movement disorders: Dystonia, Parkinsonism (PD, DLB, PSP, CBS, etc.), Essential tremor Epilepsy Psychiatric disorders: Mood disorders (Bipolar disorder, Major depressive disorder), Schizophrenia, Obsessive-compulsive disorder, Anxiety disorders Healthy volunteers Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to longitudinally evaluate changes in brain synaptic function in patients with neurological and psychiatric disorders using positron emission tomography (PET) with radiolabeled ligands targeting synaptic molecules, and to elucidate their associations with clinical symptoms, MRI indices, and blood biomarkers. Basic objectives2 - Others

Intervention: Interventions/Control_1 - PET scanning: Two of the following four synaptic radioligands are selected based on disease and ligand characteristics and administered to patient groups, healthy volunteers receive up to three ligands to minimize radiation exposure. [11C]UCB-J [18F]EST-604 [11C]ABP688 [11C]K-2 Interventions/Control_2 - Brain MRI (T1-weighted, T2-weighted, resting-state fMRI, and DTI)

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patient group

Participants must have the capacity to provide informed consent and be able to read and understand the informed consent document. In cases where the patient lacks decision-making capacity, a legally authorized representative must be able to accompany them on the day of study participation at QST. Aged 18 years or older at the time of informed consent. Patients diagnosed with one of the following conditions: dementia-related disorders (mild cognitive impairment, Alzheimer's disease, frontotemporal lobar degeneration, chronic traumatic encephalopathy), movement disorders (dystonia, Parkinsonism, essential tremor), epilepsy, or psychiatric disorders (mood disorders, schizophrenia, obsessive-compulsive disorder, anxiety disorders).

Diagnostic criteria for each condition are as follows: 1 MCI: Patients meeting the Petersen diagnostic criteria 2 AD: Patients meeting the NINCDS-ADRDA diagnostic criteria 3 Frontotemporal lobar degeneration 4 Chronic traumatic encephalopathy 5 Dystonia 6 Parkinsonism 7 Essential tremor 8 Epilepsy 9 Mood disorders 10 Schizophrenia 11 Obsessive-compulsive disorder 12 Anxiety disorders

Healthy volunteer group

Aged 18 years or older at the time of informed consent. Healthy individuals who have the capacity to provide informed consent and are able to read and understand the informed consent document. Key exclusion criteria - Patient group

1. Individuals with organic brain disorders (e.g., disturbance of consciousness, head trauma requiring hospitalization, or evident cerebral infarction or hemorrhage) 2. Individuals with comorbid substance-related disorders (e.g., drug dependence) 3. Individuals with severe comorbid medical conditions, or those with a history of such conditions, who are judged by the investigator to be inappropriate for participation in this study 4. Individuals with severe claustrophobia 5. Individuals who are pregnant, possibly pregnant, or breastfeeding 6. Individuals judged by the investigator to be unsuitable as study participants for any other reason

Healthy volunteer group 1. Individuals with organic brain disorders (e.g., disturbance of consciousness, head trauma requiring hospitalization, or evident cerebral infarction or hemorrhage) 2. Individuals with substance-related disorders (e.g., drug dependence) 3. Individuals with severe comorbid medical conditions, or those with a history of such conditions, who are judged by the investigator to be inappropriate for participation in this study 4. Individuals with pacemakers or metallic implants (e.g., intracranial clips, bolts) 5. Individuals with tattoos (including cosmetic tattoos or permanent makeup) 6. Individuals with severe claustrophobia 7. Individuals who are pregnant, possibly pregnant, or breastfeeding 8. Individuals judged by the investigator to be unsuitable as study participants for any other reason Target Size - 280

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 27 Day Date of IRB - 2026 Year 03 Month 27 Day Anticipated trial start date - 2026 Year 04 Month 14 Day Last follow-up date - 2033 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069982

Disclaimer: Curated by HT Syndication.