Study of the Indications for Amyloid Positon Emission Tomography (PET) Scans and Their Usefulness for Patients With Suspected Alzheimer's Disease (AD)

Alzheimer Disease Clinical Trial

— TEPAmy  

Official title:

Study of the Indications for Amyloid PET Scans and Their Usefulness in the Management of Patients With Suspected Alzheimer's Disease (AD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06467981
• Other study ID #: 2024PI105
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: Central Hospital, Nancy, France
• Contact: Antoine VERGER, MD, PhD
• Phone: 03 83 15 55 67
• Email: a.verger[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The recent clinical authorization of amyloid Positon Emission Tomography (PET) in France represents a crucial step for the nuclear medicine community involved in the diagnosis of Alzheimer's disease (AD).

Description:

The recent clinical authorization of amyloid Positon Emission Tomography (PET) in France represents a crucial step for the nuclear medicine community involved in the diagnosis of Alzheimer's disease (AD). At the era of Amyloid, Tau, Neurodegeneration (ATN) biomarkers, amyloid PET fills a need in patients with an atypical or mixed clinical presentation, in particular young patients (< 65 years old), when the lumbar puncture is contraindicated or not feasible for technical reasons. Importantly, a negative amyloid PET scan discards the diagnosis of AD. Furthermore, early phase imaging of amyloid PET allows to estimate the perfusion neuronal state, increasing the diagnostic value of such PET radiotracer. Its role could be further developed in routine care for the selection and monitoring of promising disease modifiers therapies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients aged = or > 18 years

• Patients who have had an amyloid PET scan with a PET request form including the indications for the examination

• Patient informed via a newsletter and non-opposition to the use of their data for research purposes (research objectives clearly explained in the letters)

Exclusion Criteria:

• Patient opposition to the use of their data for this research

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• Retrospective study
The data from the PET request form will be collected in each center for this population of patients who have had an amyloid PET scan with flutemetamol and the results of the PET examination reports will also be provided, all data will be made anonymous.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the indications for Amyloid PET in 7 centers in France to assess the relevance of the examination	Correlation between the request and the recommendations	1 day
Secondary	Evaluate the frequency of positive examinations for the diagnosis of AD	Number of positive PET exam	1 day