Using advanced imaging to diagnose early Alzheimer's disease

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。

This study is testing new imaging techniques to see if they can help doctors diagnose early Alzheimer's disease more accurately by looking at changes in the brain.

Quick facts

• Study type: Observational
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan Provincial People's Hospital (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06833645 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate early pathological changes in Alzheimer's disease using novel molecular probes, [18F]AV45(Aβ) and [18F]AV1451(Tau), through PET/CT imaging. The study will focus on identifying primary brain regions affected by Alzheimer's and the distribution of lesions that impact cognitive assessments. By establishing objective and quantitative diagnostic criteria, the study seeks to improve the accuracy of early Alzheimer's diagnosis, moving away from subjective evaluations by clinicians.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with mild cognitive impairment (MCI) or early-stage Alzheimer's disease who meet specific clinical criteria.

Not a fit: Patients with advanced dementia or those with significant neurological conditions unrelated to Alzheimer's may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and earlier diagnoses of Alzheimer's disease, allowing for timely interventions.

How similar studies have performed: Other studies utilizing similar molecular imaging techniques have shown promise in diagnosing Alzheimer's disease, suggesting a potential for success in this approach.

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.

Where this trial is running

Chengdu, Sichuan

• Departments of Nuclear Medicine, Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Hao Wang

Conditions Alzheimer's Disease