SV2A-PET/CT and PET/MRI Combined Clinical Criteria Score in the Diagnosis of Early Cognitive Alteration

N/ANot Yet RecruitingNCT06445582

Anhui Provincial Hospital80 enrolled

Overview

Using SV2A-PET to character a cohort of patients with early cognitive impairment using the novel synaptic probe 18F-labeled difluoro-analog of UCB-J（also known as 18F-SDM-8）

A community-based population (Han Chinese) in Hefei, China, based on the CANDI cohort；Single-center prospective case-control study；The projected enrollment population is 80; 40 patients with Alzheimer's Disease（AD）, 30 patients with Mild Cognitive Impairment（MCI）; 10 healthy controls. Diagnostic experiments and predictive prognostic experiments with new probes.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Alzheimer Disease

Interventions

[18F]SDM-8DIAGNOSTIC_TEST

synaptic vesicle glycoprotein 2 A（SV2A）PET tracer \[18F\]SDM-8

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * AD Group * All diagnostic criteria for AD patients met the National Institute of Neurological Speech-Language Disorders Stroke Institute and Alzheimer's Disease and Related Disorders Association criteria; * Comply with the American Psychiatric Association Diagnostic and Statistical Workbook of Mental Disorders, 5th edition (DSMIV); * All subjects were unconscious and could be accompanied by behavioral and psychiatric abnormalities. Subjects who meet the above criteria are eligible for enrollment. * Those who understand the process of this clinical trial and sign the informed consent form (in addition, non-AD volunteers will be recruited through verbal dissemination and posting of paper advertisements to serve as the non-AD control group, and the final control group will be screened by the clinician and consist of healthy people of similar age and gender). * MCI Group * Concerns about cognitive changes, and concerns about finding changes in comparison with one's prior level may originate from the patient himself or herself, from an informed person, or from an experienced specialist; * Impairment of one or more cognitive areas, primarily memory, executive function, attention, language, and visuospatial function; * Maintaining independence in daily living, there can be minor impairment in complex instrumental daily abilities; * Absence of dementia, mild disease, and no evidence of serious impairment of social or occupational abilities; * Presence of one of the Aβ class biomarkers and/ neuronal damage class markers detected by imaging, cerebrospinal fluid; * All subjects and their guardians give informed consent to the study and sign the informed consent form; Exclusion Criteria: * With confirmed cerebrovascular disease, the presence of multiple or extensive cerebral infarcts; * Other types of dementia: Parkinson's disease dementia, vascular dementia, frontotemporal lobe dementia, dementia with Lewy bodies; * Sudden onset or stroke-like episodes; * Early onset of focal neurological symptoms, such as hemiparesis, computational deficits, ataxia, or sensory loss; * Seizures or gait abnormalities early in the onset of the disease; * Evidence of drug applications that cause significant effects on cognitive function; * Those who are allergic to alcohol; * Persons with alcohol allergy; (ix) Persons with left-handedness; (x) Persons with left-handedness; * Those with claustrophobia or other reasons for not being able to cooperate with the examination; * Those with serious heart, liver, lung, kidney and other organ diseases, meeting the above conditions were excluded from the group.

Outcomes

Primary Outcomes

SUVR（Standardized Uptake Value Ratio）

Standardized semi-quantitative values of SUVR for each brain region of the cerebral cortex；Standardized Uptake Value ratio (SUVr) is a metric used to evaluate the results of PET scans of the brain. It is a measure of the extent of abnormal metabolism or abnormal deposits in a brain region by comparing the uptake value of a specific brain region to the uptake values of neighboring regions. SUVr is calculated as follows: 1. first, a reference region is selected, usually an adjacent region of healthy tissue that is unaffected by disease. 2. then, the uptake value for the region of interest (e.g., the brain region), denoted as SUV, is calculated. 3. next, the average uptake value of the reference region, denoted as SUVref, is calculated. 4. finally, the SUVr is calculated, obtained by dividing the SUV of the region of interest by the SUVref of the reference region.

Time frame: 1year

Secondary Outcomes

AUC（Area under the curve）of SUVR

AUC is defined as the area under the ROC curve enclosed with the axes. ROC (receiver operating characteristic curve) receiver operating characteristic curve, is invented by electronic engineers and radar engineers in World War II used to detect enemy carriers (aircraft, ships) on the battlefield indicators, belongs to the signal detection theory. The SV2A SUVR calculation was performed using the reference brain region method described above, and the AUC was used to measure the ability of the SUVR to classify the AD disease spectrum versus healthy controls, and its correlation with clinical scale scores was analyzed.

Time frame: 1year

Central Contacts

Zehua Zhu, MD

CONTACT

15243611341 zhuzehua2023@ustc.edu.cn

Data from ClinicalTrials.gov

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