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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSichuan Provincial People's Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

280 Participants
are divided into 3 treatment groups
Group A: Mild cognitive impairment,MCI1 intervention
Group B: Alzheimer's disease,AD1 intervention
Group C: Healthy volunteer1 intervention

Trial outcomes

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.

Time frame
2 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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