18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study (MAF)
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|ClinicalTrials.gov Identifier: NCT02556502|
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : August 11, 2017
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
|Condition or disease||Intervention/treatment|
|Amyloid PET Imaging||Device: 18F-Florbetaben PET|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2017|
U.S. FDA Resources
|Experimental: FDG PET positive or negative||Device: 18F-Florbetaben PET|
- number of positive or negative amyloid PET [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556502
|Contact: Antoine VERGER, AHU||03 83 15 51 48|
|Vandoeuvre les Nancy, France, 54511|
|Contact: VERGER Antoine, AHU|