Risk of Developing Dementia and Associated Factors in Pat... | NCT04804722

Studies
Risk of Developing Dementia and Associated Factors in Patients With Normal Brain FDG PET

NCT04804722

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Jul 6, 2023Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Neurodegenerative Diseases
Cognitive Disorder

Interventions

18F-FDG PET-CT (fluorodesoxyglucose positron emission tomography)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2022Actual

Primary Completion Date

Jul 1, 2023Actual

Completion Date

Jul 1, 2023Actual

First Submitted Date

Mar 16, 2021

First Submission Date that Met QC Criteria

Mar 16, 2021

First Posted Date

Mar 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2023

Last Update Posted Date

Jul 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Antoine VERGER, MD, PhD, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 0.1 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 Alzheimer's 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 0.1 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 Alzheimer's 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-FDG PET-CT (fluorodesoxyglucose positron emission tomography)	Device	18F-FDG PET-CT exams during 30 minutes with injection of radiopharmaceutical product

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Normal brain 18F-FDG PET	Number of patients with normal brain 18F-FDG PET who developed dementia with a clinical follow-up of at least 3 years	3 years

Secondary Outcomes

Measure	Description	Time Frame
Predictive parameters for the occurrence of dementia	Predictive parameters for the occurrence of dementia in patients with normal brain 18F-FDG PET with a clinical follow-up of at least 3 years	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient who had a PET scan with 18F-FDG in the brain at least 3 years previously
Patients referred for PET scans for cognitive disorders, whether or not they have been diagnosed
Patients referred for PET scans for neurodegenerative pathology 18F-FDG PET brain scan interpreted as normal

Exclusion Criteria:

Brain 18F-FDG PET scan considered abnormal after semi-quantitative analysis

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient who had a PET scan with 18F-FDG in the brain at least 3 years previously for cognitive disorders or neurodegenrative pathology

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nuclear medicine Department CHRU de NANCY		Vandœuvre-lès-Nancy		54511	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39135067	Derived	Heyer S, Simon M, Doyen M, Mortada A, Roch V, Jeanbert E, Thilly N, Malaplate C, Kearney-Schwartz A, Jonveaux T, Bannay A, Verger A. 18F-FDG PET can effectively rule out conversion to dementia and the presence of CSF biomarker of neurodegeneration: a real-world data analysis. Alzheimers Res Ther. 2024 Aug 13;16(1):182. doi: 10.1186/s13195-024-01535-3.

ID	Term
D019636	Neurodegenerative Diseases
D060825	Cognitive Dysfunction

ID	Term
D009422	Nervous System Diseases
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders