Alzheimer's Disease: Clinical Investigation and Neuroimage Studies Including 18F-PM-PBB3 and 18F-florbetapir (AV-45) PET Examination (PMPBB3/AV45)
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|ClinicalTrials.gov Identifier: NCT04305210|
Recruitment Status : Unknown
Verified March 2019 by Chang Gung Memorial Hospital.
Recruitment status was: Recruiting
First Posted : March 12, 2020
Last Update Posted : March 12, 2020
Dementia is a common neurodegenerative syndrome in aged population. Alzheimer's disease (AD) is the most common disease. The main pathological findings in AD include senile plaques (SP) and neurofibrillary tangles (NFT). The b-amyloid is the main peptide in SP and tau protein is the main finding in NFT. In addition, b-amyloid is considered as a disease biomarker, but the severity of AD is related with the tau protein.
Recently a new tracer 18F-PM-PBB3 has been introduced in tau PET images. In a prelimary study with the 18F-PM-PBB3, the tau PET scan provide a good tool to evaluate tau deposition pattern among healthy volunteers, and patients with mild and moderate dementia due to AD. In this study we will enroll 20 healthy controls, 20 amnestic mild cognitive impairment patients (aMCI), 20 mild-moderate dementia due to AD patients and 10 other dementia such as frontotemporal dementia patients. All of the subjects will receive 18F-PM-PBB3 tau PET scan, and 18F-flobetapir (AV-45) amyloid PET scan, brain magnetic resonance images and clinical evaluation. We will follow up the clinical features for 2 years to understand the disease progression, disease conversion from aMCI to AD.
The study aims to investigate the deposition patterns of tau protein with 18F-PM-PBB3 and amyloid protein with 18F-flobetapir in patients with amnestic mild cognitive impairment due to AD, mild to moderate degree of dementia due to AD and healthy controls. The study will provide the information of these two proteins in different stages of dementia patients. The results may help the strategy in selection of anti-dementia drugs in the pharmaceutical company and industry and reduce the economic burden for the society. The study also can improve the understanding of Alzheimer's disease in academic research.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: F-18 PMPBB3 Drug: 18F-florbetapir||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Alzheimer's Disease: Clinical Investigation and Neuroimage Studies Including 18F-PM-PBB3 and 18F-florbetapir (AV-45) PET Examination|
|Actual Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||January 23, 2021|
|Estimated Study Completion Date :||January 23, 2021|
Drug: F-18 PMPBB3
In this study we will enroll 20 healthy controls, 20 amnestic mild cognitive impairment patients (aMCI), 20 mild-moderate dementia due to AD patients and 10 other dementia such as frontotemporal dementia patients. All of the subjects will receive 18F-PM-PBB3 tau PET scan, and 18F-flobetapir (AV-45) amyloid PET scan, brain magnetic resonance images and clinical evaluation.
18F-florbetapir (AV45) imaging
- Tau Distribution [ Time Frame: 1 YEAR ]Tau Distribution Among healthy controls, amnestic mild cognitive impairment patients (aMCI), mild-moderate dementia due to AD and other dementia such as frontotemporal dementia. Subjects Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-PM-PBB3 tau PET Scan and AV45 amyloid pet scan.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04305210
|Contact: Chin-Chang Huang, MD||03-3281200 ext email@example.com|
|Chang Gung Memorial Hospital,Linkou||Recruiting|
|Taoyuan, Guishan Dist,, Taiwan, 333|
|Contact: Chin-Chang Huang, MD 03-3281200 ext 8340 firstname.lastname@example.org|