NCT04604600

Multimodal Biomarkers for Diagnosis and Prognosis in VCI

Multimodal Biomarkers for Diagnosis and Prognosis in Vascular Cognitive Impairment

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Accepted

Summary

We will try to 1. establish the correlation of plasma Aβ40 and Aβ42 level, ApoE genotype, MRI imaging markers in the diagnosis and prognosis of VCI patients 2. understand more on the pathophysiology of VCI.

Detailed description

Background and objectives Owing to the aging problem, cognitive impairment has been a worldwide health issue. Vascular cognitive impairment (VCI) and Alzheimer's disease (AD) are the two most common causes. It has been reported that VCI and AD share many common risk factors. MRI is essential in assessing the extent, location and type of vascular lesions. Amyloid PET has been used in detecting cerebral amyloid burden non-invasively since 2004. There are only small number of studies using amyloid PET in VCI and the results are still controversial. In the current proposal, we will investigate 1. the correlation of clinical risk factors, ApoE genotype, various MRI markers, and amyloid PET expression 2. assess the influence of ApoE genotype on different biomarkers, including MRI markers, amyloid retention, and plasma Aβ40 and Aβ42 levels 3. the potential of amyloid PET as a prognostic factor for VCI patients. Materials and methods This study will be conducted in National Taiwan University Hospital and Bei-Hu Branch Hospital. Sixty clinical diagnosed VCI, 30 AD patients and 30 normal subjects will be enrolled in this 3-year prospective study. We will collect vascular risk factors, neuropsychological tests, 10 cc venous blood for plasma Aβ40, Aβ42, total tau and phosphorylated level measurement by IMR assay, ApoE genotype, brain MRI, and amyloid PET of each patient and control subject. All the data will be analyzed together. Expected Results We will try to 1. establish the correlation of plasma Aβ40 and Aβ42 level, ApoE genotype, MRI imaging markers in the diagnosis and prognosis of VCI patients 2. understand more on the pathophysiology of VCI.

Conditions

• Vascular Cognitive Impairment
• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	amyloid PET	Dynamic PET acquisition for 70 minutes will be acquired after injection of 10±5 mCi 11C-PiB.

Timeline

• Start date: 2020-09-03
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2020-10-27
• Last updated: 2020-10-27

Locations

1 site across 1 country: Taiwan