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

NCT04804722 | Completed

• 1 other identifier: 2021PI044
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodegenerative Diseases; Cognitive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Predictive parameters for the occurrence of dementia

  3 years

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Nuclear medicine Department CHRU de NANCY

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

• 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.

  PMID: 39135067 DERIVED

MeSH Terms

Conditions

Neurodegenerative Diseases; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: January 20, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)