Aβ PET and Tau PET Imaging in the Diagnosis and Progression Assessment of Alzheimer's Disease

NCT ID: NCT07114224

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2027-06-01

Brief Summary

This prospective study recruited 20 healthy volunteers and 50 patients diagnosed with Alzheimer's disease (AD) and mild cognitive impairment (MCI) according to clinical guidelines. Participants underwent AV45/AV-1 and AV1451 PET imaging to obtain information on Aβ protein deposition, tau protein distribution, and structural and functional information. The study aims to evaluate the value of multimodal imaging features in the diagnosis and progression assessment of AD, providing imaging evidence for novel treatment modalities such as lecanemab therapy and deep cervical vein-lymphatic anastomosis.

Conditions

Alzheimer Disease (AD); Cognitive Dysfunction, Cognitive Disorder; PET Imaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

normal volunteer group

Group Type: EXPERIMENTAL

AV45/AV-1、AV1451 PET

Intervention Type: DIAGNOSTIC_TEST

Use PET equipment to collect multimodal imaging data. Sixty to ninety minutes after intravenous injection of 3.7 MBq/kg of 18F-AV45 or 18F-AV1, perform PET imaging in list mode to simultaneously collect structural and functional information under the same pathophysiological conditions.

The next day, perform 18F-AV1451 PET imaging to obtain tau protein distribution information.

Alzheimer's disease and cognitive impairment group

Group Type: EXPERIMENTAL

AV45/AV-1、AV1451 PET

Intervention Type: DIAGNOSTIC_TEST

Use PET equipment to collect multimodal imaging data. Sixty to ninety minutes after intravenous injection of 3.7 MBq/kg of 18F-AV45 or 18F-AV1, perform PET imaging in list mode to simultaneously collect structural and functional information under the same pathophysiological conditions.

The next day, perform 18F-AV1451 PET imaging to obtain tau protein distribution information.

Interventions

AV45/AV-1、AV1451 PET

Use PET equipment to collect multimodal imaging data. Sixty to ninety minutes after intravenous injection of 3.7 MBq/kg of 18F-AV45 or 18F-AV1, perform PET imaging in list mode to simultaneously collect structural and functional information under the same pathophysiological conditions.

The next day, perform 18F-AV1451 PET imaging to obtain tau protein distribution information.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age: 18-75 years old; Healthy volunteers: males weighing ≥50 kg, females weighing ≥45 kg, with a body mass index (BMI = weight (kg)/height² (m²)) within the range of 19.0-28.0 kg/m² (including boundary values); Cognitive disorders diagnosed clinically according to guidelines include Alzheimer's disease (AD) and mild cognitive impairment (MCI). Diagnostic criteria are as follows: 1) Clinical manifestations include symptoms such as memory impairment, difficulty concentrating, slowed thinking, and poor language skills; 2) Neuropsychological tests show that functions such as memory, attention, thinking, and language are below the normal population level; 3) Blood or cerebrospinal fluid tests show elevated levels of human β-amyloid 1-42, human β-amyloid 1-40, and human phosphorylated tau protein. 4) Exclusion of other factors that may cause cognitive impairment, such as drug or substance abuse, environmental factors, etc.; Signing an informed consent form for PET/MR or PET/CT examinations and voluntarily participating in this study.

Exclusion Criteria

• Minors, pregnant women, breastfeeding women, individuals with severe liver or kidney dysfunction, and those with a history of allergy to contrast agents or other medications; Diagnosed with viral encephalitis, acute myelitis, idiopathic epilepsy, or antibody-negative AIE; Diagnosed with any major illness; history of alcohol or drug abuse/dependence; History of cardiovascular disease, tumours, blood disorders, or poorly controlled chronic conditions; Contraindications for PET/MR imaging. History of head trauma or surgery; History of other neurological disorders.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

KY20252271

Identifier Type: -

Identifier Source: org_study_id