NCT04169126

Topography Staging and Dual Phase Image Quantification of Tau PET in Cognitive Impairment Subjects

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A second-generation tau PET image tracer 18F-PM-PBB3 (APN-1607 or MNI-958) has been developed by National Institute of Radiological Sciences. The new tracer solved the off-target binding issue. This study will evaluate new quantitative methods with PMPBB3, by utilized dual phase scanning protocol to extract blood flow and Tau protein binding information, to evaluate appropriate reference brain regions, to improve the normalization efficiency of brain imaging, and to establish a brain template image analysis platform.

Detailed description

Dementia is the top issue in the aging society. Aging population also has its negative implications for the global economy. Effective diagnosis and treatment of dementia is important. Alzheimer's disease accounts for more than 60% of dementia. The main pathological features are the amyloid deposition and Tau neurofibrillary tangles. Currently, our understanding for these misfolded proteins and dementia is limited. There is a need for development of new imaging biomarkers to help clarify the pathophysiology of dementia. In recent years, molecular imaging technology has developed rapidly. In addition to amyloid imaging tracer have been put into clinical use, Tau protein imaging biomarkers have also entered clinical research. However, the tau protein within the patient's brain is not evenly distributed. And the amount of the Tau protein radioactivity is not simply correlate to dementia disease staging. In addition, the problem of off-target binding of the first generation of tracers has yet to be resolved. Recently a second-generation tau PET image tracer 18F-PM-PBB3 (APN-1607 or MNI-958) has been developed by National Institute of Radiological Sciences. The new tracer solved the off-target binding issue. This study will evaluate new quantitative methods with PMPBB3, by utilized dual phase scanning protocol to extract blood flow and Tau protein binding information, to evaluate appropriate reference brain regions, to improve the normalization efficiency of brain imaging, and to establish a brain template image analysis platform. The investigators will evaluate the relationship between Tau protein uptake pattern and disease classifications, and the correlation between Tau protein neurofibrillary tangles and amyloid deposition, and the correlation between MRI and glucose brain connectivity. Finally, to understand the pathophysiology of Tau protein in dementia disease.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	F-18 PMPBB3	The study will enroll 200 patients with prodromal AD and AD dementia and 100 normal controls, men and women aged 55-80 years across core clinical criteria of prodromal AD and mild AD dementia based on IWG-2 criteria.

Timeline

• Start date: 2019-04-01
• Primary completion: 2023-03-31
• Completion: 2023-09-30
• First posted: 2019-11-19
• Last updated: 2021-01-27

Locations

1 site across 1 country: Taiwan