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

NCT06833645 | Recruiting

• 1 other identifier: SichuanPPH-AD
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To establish diagnostic criteria of Aβ and TauPET/CT imaging

  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.

  2 months

Study Arms (3)

Mild cognitive impairment，MCI

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

Alzheimer's disease，AD

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

Healthy volunteer

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

Interventions

molecular probe [18F]AV45(Aβ) and [18F]AV1451(Tau) 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; Healthy volunteer; Mild cognitive impairment，MCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

It is expected to include 100 patients with MCI, 100 patients with AD, and 80 patients in the NC group, A total of 280 patients, all of whom received Aβ and TauPET/CT imaging. There were 180 males and 100 females.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Departments of Nuclear Medicine, Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Molecular Probes

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Laboratory Chemicals; Specialty Uses of Chemicals

Study Officials

• Hao Wang

  Sichuan Provincial People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Hao Wang

CONTACT

+8618313820216; 474556259@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: February 19, 2025
• Study Start: May 10, 2024
• Primary Completion: February 19, 2025
• Study Completion: February 25, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

CN (1)