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

June 4, 2025 updated by: Antoine VERGER, Central Hospital, Nancy, France

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre/les/Nancy, France, 54511
        • Nuclear Medicine Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients who had a flutemetamol amyloid PET scan with a PET request form including the indications for the examination and who received the information letter on the objectives of the research and who did not object to the use of their data.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the indications for Amyloid PET in 7 centers in France to assess the relevance of the examination
Time Frame: 1 day
Correlation between the request and the recommendations
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the frequency of positive examinations for the diagnosis of AD
Time Frame: 1 day
Number of positive PET exam
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

February 15, 2025

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024PI105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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