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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-30

Study Completion Date

2025-12-31

Brief Summary

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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）

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Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CANDI

China Aging and Neurodegenerative Initiative

[18F]SDM-8

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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[18F]SDM-8

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes