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

Last updated: February 18, 2025
Sponsor: Sichuan Provincial People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alzheimer's Disease

Dementia

Memory Loss

Treatment

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

Clinical Study ID

NCT06833645
SichuanPPH-AD
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 cognitivedomains;

  • 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 theDiagnostic and Statistical Manual of Mental Disorders (DSM-IV-R), Use the diagnosticcriteria for AD from the National Institute of Neurology, Speech and CommunicationDisorders and Stroke - Alzheimer's Disease and Related Disorders (NINCDS-ADRDA) orthe National Institute on Aging and Alzheimer's Disease Association (NIA-AA).

  • Clinical Dementia Rating Scale score was 1 point.

Exclusion

Exclusion Criteria:

  • Patients with a history of stroke and focal neurological signs, and imaging findingsconsistent 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 pressurehydrocephalus);

  • The presence of other systemic diseases that can cause cognitive impairment (such asliver insufficiency, renal insufficiency, thyroid dysfunction, severe anemia, folicacid 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

Total Participants: 280
Treatment Group(s): 1
Primary Treatment: molecular probe [18F]AV45(Aβ) and [18F]AV1451(Tau)
Phase:
Study Start date:
May 10, 2024
Estimated Completion Date:
February 25, 2025

Connect with a study center

  • Departments of Nuclear Medicine, Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610072
    China

    Active - Recruiting

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