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

NCT ID: NCT06833645

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 280 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-10
• Study Completion Date: 2025-02-25

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.

Conditions

Alzheimer's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Mild cognitive impairment，MCI

molecular probe [18F]AV45(Aβ) and [18F]AV1451(Tau)

Intervention Type: OTHER

The new imaging agents Aβ and TauPET/CT are molecular imaging, which have the advantage of earlier and more visual, and can study the mechanism of pathological changes and PET manifestations of Alzheimer's disease before symptoms appear from the molecular level.

Alzheimer's disease，AD

molecular probe [18F]AV45(Aβ) and [18F]AV1451(Tau)

Intervention Type: OTHER

The new imaging agents Aβ and TauPET/CT are molecular imaging, which have the advantage of earlier and more visual, and can study the mechanism of pathological changes and PET manifestations of Alzheimer's disease before symptoms appear from the molecular level.

Healthy volunteer

molecular probe [18F]AV45(Aβ) and [18F]AV1451(Tau)

Intervention Type: OTHER

The new imaging agents Aβ and TauPET/CT are molecular imaging, which have the advantage of earlier and more visual, and can study the mechanism of pathological changes and PET manifestations of Alzheimer's disease before symptoms appear from the molecular level.

Interventions

molecular probe [18F]AV45(Aβ) and [18F]AV1451(Tau)

The new imaging agents Aβ and TauPET/CT are molecular imaging, which have the advantage of earlier and more visual, and can study the mechanism of pathological changes and PET manifestations of Alzheimer's disease before symptoms appear from the molecular level.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hao Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hao Wang

Role: STUDY_DIRECTOR

Sichuan Provincial People's Hospital

Locations

Departments of Nuclear Medicine, Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hao Wang

Role: CONTACT

474556259@qq.com

+8618313820216

Facility Contacts

Hao Wang, Doctor

Role: primary

474556259@qq.com

+86-18313820216

Other Identifiers

SichuanPPH-AD

Identifier Type: -

Identifier Source: org_study_id