[18F]AV45(Aβ) and [18F]AV1451(Tau)PET/CT in the Diagnosis of Early Pathological Changes of Alzheimer's Disease

Recruiting

• Conditions: Alzheimer's Disease

• Registration Number: NCT06833645
• Lead Sponsor: Sichuan Provincial People's Hospital

Brief Summary

To investigate the primary brain regions of precursors of Alzheimer's disease and Alzheimer's disease by novel molecular probe \[18F\]AV45(Aβ) and \[18F\]AV1451(Tau)PET/CT imaging. And the distribution of positive lesions in the brain area affecting the simple mental state examination and the Montreal Cognitive Assessment Scale in AD patients; It is expected to provide molecular imaging information for further study of the pathogenesis of AD. After clinical transformation, objective and quantitative positive diagnostic criteria for \[18F\]AV45 and \[18F\]AV1451PET/CT in the diagnosis of early Alzheimer's disease were established to avoid the defects of relying on the subjective experience of doctors and time-consuming diagnosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-10
• Study First Submitted: 2024-07-13
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Primary Completion: 2025-02-19
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Study Completion: 2025-02-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Meet the MCI diagnostic criteria of Peterson in 2004;
• The clinicaldementiarating Scale (CDR) score was 0.5;
• Prominent memory loss may also be accompanied by impairment of other cognitive domains;
• Insidious onset and slow progression;
• Not at the level of dementia.

AD entry criteria:

• Meet the criteria for diagnosing dementia as described in the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R), Use the diagnostic criteria for AD from the National Institute of Neurology, Speech and Communication Disorders and Stroke - Alzheimer's Disease and Related Disorders (NINCDS-ADRDA) or the National Institute on Aging and Alzheimer's Disease Association (NIA-AA).
• Clinical Dementia Rating Scale score was 1 point.

Exclusion Criteria

• Patients with a history of stroke and focal neurological signs, and imaging findings consistent with small cerebral vascular disease (Fazekas score ≥2);
• The presence of other neurological disorders that can cause brain dysfunction (e.g., depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, Normal facial pressure hydrocephalus);
• The presence of other systemic diseases that can cause cognitive impairment (such as liver insufficiency, renal insufficiency, thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
• There is mental and neurological retardation.
• There are other diseases that are known to cause cognitive impairment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish diagnostic criteria of Aβ and TauPET/CT imaging	2 months	The areas of aβ and Tau positive lesions correlated with MMSE and MOCA scores were obtained.The SUVR cut-off values of aβ and Tau PET/CT for detecting positive lesions were obtained.

Trial Locations

Locations (1)

Departments of Nuclear Medicine, Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China