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

NCT ID: NCT04804722

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-20

Study Completion Date

2023-07-01

Brief Summary

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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

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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.

Conditions

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Neurodegenerative Diseases Cognitive Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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

18F-FDG PET-CT exams during 30 minutes with injection of radiopharmaceutical product

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Antoine VERGER

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nuclear medicine Department CHRU de NANCY

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 39135067 (View on PubMed)

Other Identifiers

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2021PI044

Identifier Type: -

Identifier Source: org_study_id

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