Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402370
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-02
Brief Title:
Amyloid PET in Patients With Mild Cognitive Impairment and Early Dementia
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Amyloid PET in Patients With Mild Cognitive Impairment and Early Dementia
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The National Institute on Aging together with the Alzheimers Association NIA-AA recently proposed the ATN classification which is based upon the pathological processes present in Alzheimers disease amyloid tau and neurodegeneration The amyloid and tau status can be defined using cerebrospinal fluid analysis but also non-invasively using an amyloid or tau PET scan The N status can be defined using an 18F-FDG PET scan which is in Belgium part of standard of care Recently it has been demonstrated using different amyloid PET tracers that early-frame amyloid scans can be a surrogate for 18F-FDG PET scan
Detailed Description:
With the general aging of the population neurodegenerative diseases such as Alzheimer have an increasing prevalence Recently anti-β-amyloid-antibodies such as aducanumab and donanemab are under development These treatments urge for techniques allowing early diagnosis and treatment monitoring during disease 18FFDG PET allows the visualization of metabolic disturbances and aid in the early diagnosis of Alzheimer Amyloid PET is able to detect the amyloid plaques which can be present years before symptom onset A recent meta-analysis demonstrated that amyloid PET has a high sensitivity 091 and specificity 081 in the differential diagnosis between Alzheimer and controls however very poor specificity 041 was observed when differentiating between Alzheimer and patients with mild cognitive impairment
The National Institute on Aging together with the Alzheimers Association NIA-AA recently proposed the ATN classification which is based upon the pathological processes present in Alzheimers disease amyloid tau and neurodegeneration The amyloid and tau status can be obtained using cerebrospinal fluid analysis but also non-invasively using an amyloid or tau PET scan The N status can be obtained using an 18FFDG PET scan which is in Belgium part of standard of care Both the 18FFDG PET scan and the amyloid scans using 18FVizamyl are also proposed in the diagnostic algorithm for early and differential diagnoses of dementia
Perfusion scans using 15OH2O have shown a good correlation with 18FFDG PET illustrating the potential of perfusion as a proxy for neuronal dysfunction Previously it has been demonstrated that early amyloid scans represent perfusion and can therefore be used as a proxy for neuronal activity
Next generation PETCT scanners such as the Omni Legend have a very high sensitivity which may enable ultra-short PET scans which is important is this vulnerable patient group or dynamic scans with a high effective time resolution due to the possibility to acquire short time frames with reasonable noise characteristics Moreover the ultrashort scan may limit the movement artefacts frequently encountered in this study population
The investigators hypothesize that a one minute scan 5 minutes postinjection is sufficient to determine the N-status of a patients and that a one minute scan 90-110 minutes postinjection can determine the A-status
The National Institute on Aging together with the Alzheimers Association NIA-AA recently proposed the ATN classification which is based upon the pathological processes present in Alzheimers disease amyloid tau and neurodegeneration The amyloid and tau status can be obtained using cerebrospinal fluid analysis but also non-invasively using an amyloid or tau PET scan The N status can be obtained using an 18FFDG PET scan which is in Belgium part of standard of care Both the 18FFDG PET scan and the amyloid scans using 18FVizamyl are also proposed in the diagnostic algorithm for early and differential diagnoses of dementia
Perfusion scans using 15OH2O have shown a good correlation with 18FFDG PET illustrating the potential of perfusion as a proxy for neuronal dysfunction Previously it has been demonstrated that early amyloid scans represent perfusion and can therefore be used as a proxy for neuronal activity
Next generation PETCT scanners such as the Omni Legend have a very high sensitivity which may enable ultra-short PET scans which is important is this vulnerable patient group or dynamic scans with a high effective time resolution due to the possibility to acquire short time frames with reasonable noise characteristics Moreover the ultrashort scan may limit the movement artefacts frequently encountered in this study population
The investigators hypothesize that a one minute scan 5 minutes postinjection is sufficient to determine the N-status of a patients and that a one minute scan 90-110 minutes postinjection can determine the A-status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None