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NCT Number: NCT06833645

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Departments of Nuclear Medicine, Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location status: Recruiting

Location contact

Hao Wang, Doctor

CONTACT

[email protected]

+86-18313820216

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. To establish diagnostic criteria of Aβ and TauPET/CT imaging

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study 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。

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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