Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04804722
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2021-03-16
Brief Title:
Risk of Developing Dementia and Associated Factors in Patients With Normal Brain FDG PET
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Risk of Developing Dementia and Associated Factors in Patients With Normal Brain FDG PET
Status:
COMPLETED
Status Verified Date:
2023-07
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:
NOBET
Brief Summary:
Brain 18F-FDG PET positron emission tomography is recognised as having a good negative predictive value in the search for a neurodegenerative origin of cognitive disorders Indeed a ratio of 01 on the occurrence of worsening cognitive disorders has been reported in case of normal brain FDG PET
However the risk of developing objective cognitive disorders in patients with no cognitive complaints is estimated at 8 per year and the risk of developing dementia in patients with mild cognitive disorders at 22 per year
Cerebral 18F-FDG PET is a prognostic factor for the occurrence of unusual clinical manifestations MCI or the conversion of MCI to Alzheimers disease but we do not really know the impact on the longer term occurrence of cognitive impairment in patients with normal cerebral 18F-FDG PET
Only a longitudinal study will allow us to really know the true negative predictive value of a normal 18F-FDG PET scan and the factors associated with a risk of dementia in these subjects This will allow us to better understand the prognostic impact of a normal brain 18F-FDG PET scan and to identify a sub-population that remains at risk including in the case of normal brain 18F-FDG PET
However the risk of developing objective cognitive disorders in patients with no cognitive complaints is estimated at 8 per year and the risk of developing dementia in patients with mild cognitive disorders at 22 per year
Cerebral 18F-FDG PET is a prognostic factor for the occurrence of unusual clinical manifestations MCI or the conversion of MCI to Alzheimers disease but we do not really know the impact on the longer term occurrence of cognitive impairment in patients with normal cerebral 18F-FDG PET
Only a longitudinal study will allow us to really know the true negative predictive value of a normal 18F-FDG PET scan and the factors associated with a risk of dementia in these subjects This will allow us to better understand the prognostic impact of a normal brain 18F-FDG PET scan and to identify a sub-population that remains at risk including in the case of normal brain 18F-FDG PET
Detailed Description:
Brain 18F-FDG PET is known to have a good negative predictive value in the search for a neurodegenerative origin to cognitive disorders Indeed a ratio of 01 on the occurrence of worsening cognitive disorders has been reported in case of normal brain FDG PET
However in patients without cognitive complaints the risk of developing objective cognitive impairment is estimated to be 8 per year and the risk of developing dementia in patients with mild cognitive impairment 22 per year
Brain 18F-FDG PET is a prognostic factor for the occurrence of MCI or for the conversion of MCI to Alzheimers disease but we do not really know the impact on the longer-term occurrence of cognitive impairment in patients with a normal brain 18F-FDG PET
Also it is commonly accepted that a normal brain 18F-FDG PET scan can rule out a neurodegenerative origin for cognitive impairment
However the detection sensitivity of brain 18F-FDG PET is about 90 Furthermore we do not know the pathophysiological factors that cause false negative PET scans and it would be interesting to study them age sex medical history results of neuropsychological tests etc
Based on subjects available freely on the internet an American team showed that brain 18F-FDG PET was predictive of cognitive decline in subjects with no or minor cognitive disorders
Only a longitudinal study will allow to really know the true negative predictive value of a normal 18F-FDG PET scan and the factors associated with a risk of dementia in these subjects This will allow us to better understand the prognostic impact of a normal brain 18F-FDG PET scan and to identify a subpopulation that remains at risk including in case of normal brain 18F-FDG PET
However in patients without cognitive complaints the risk of developing objective cognitive impairment is estimated to be 8 per year and the risk of developing dementia in patients with mild cognitive impairment 22 per year
Brain 18F-FDG PET is a prognostic factor for the occurrence of MCI or for the conversion of MCI to Alzheimers disease but we do not really know the impact on the longer-term occurrence of cognitive impairment in patients with a normal brain 18F-FDG PET
Also it is commonly accepted that a normal brain 18F-FDG PET scan can rule out a neurodegenerative origin for cognitive impairment
However the detection sensitivity of brain 18F-FDG PET is about 90 Furthermore we do not know the pathophysiological factors that cause false negative PET scans and it would be interesting to study them age sex medical history results of neuropsychological tests etc
Based on subjects available freely on the internet an American team showed that brain 18F-FDG PET was predictive of cognitive decline in subjects with no or minor cognitive disorders
Only a longitudinal study will allow to really know the true negative predictive value of a normal 18F-FDG PET scan and the factors associated with a risk of dementia in these subjects This will allow us to better understand the prognostic impact of a normal brain 18F-FDG PET scan and to identify a subpopulation that remains at risk including in case of normal brain 18F-FDG PET
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