18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study

Not Applicable

Completed

• Conditions: Amyloid PET Imaging
• Interventions: Device: 18F-Florbetaben PET

• Registration Number: NCT02556502
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The diagnosis of Alzheimer's disease (AD) is based on clinical and neuropathological criteria.

Some patients have a contributive CSF biology to determinate a high level risk of AD (Tau + phospho-tau ratio increased and Ab42 / decreased Aβ40), but others have an intermediate CSF biology (Tau and/or phospho-tau increased but Ab42 ratio / normal Aβ40) and are unclassifiable.

18F-Florbetaben (Neuraceq®), a radioisotope in positron emission tomography (PET), selectively binds to amyloid plaques, with high detection sensitivity (98%).

Detection of amyloid plaques by PET imaging separate patients according to the criteria of Dubois, as with AD and allow them to benefit a cholinesterase inhibitor treatment.

If negative, the diagnosis of AD can be excluded with a high level of confidence to prevent initiating unnecessary treatment, expensive for the community.

This is the first imaging study of amyloid plaques targeting population whose diagnosis of AD is uncertain according to the CSF biology.

The aim of this study is to describe the results of amyloid PET in case of intermediate CSF biology and to separate patients as AD or not according to the criteria of Dubois

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Study Start: 2015-11
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Major subjects who have given their consent to participate in the study.
• Patients with suspected AD and whose CSF markers give intermediate results (CSF punction less than 6 months): meaning tau and/or phospho-tau increased and Ab42 / Aβ40 normal (Ab42 / Aβ40 > 0.07).
• Non-indication to perform a PET 18F-Florbetaben.
• Affiliation to the french social security .

Exclusion Criteria

• Patients under guardianship.
• Inability to perform a PET 18F-Florbetaben (agitated patient, confused, ..).
• Pregnancy, lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FDG PET positive or negative	18F-Florbetaben PET	-

Primary Outcome Measures

Name	Time	Method
number of positive or negative amyloid PET	2 years

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Vandoeuvre les Nancy, France