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Recruiting NCT06833645

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

Observational Alzheimer's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: molecular probe [18F]AV45(Aβ) and [18F]AV1451(Tau).
Who it may be relevant to
Registry conditions: Alzheimer's Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

To Investigate the Mechanism of Novel Molecular Probe [18F]AV45(Aβ) and [18F]AV1451(Tau)PET/CT in the Diagnosis of Early Pathological Changes of Alzheimer's Disease。

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • To establish diagnostic criteria of Aβ and TauPET/CT imaging [Time frame: 2 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Departments of Nuclear Medicine, Sichuan Provincial People's Hospital — Chengdu

Identifiers

NCT: NCT06833645 · SichuanPPH-AD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗