- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02556502
18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study (MAF)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vandoeuvre les Nancy, France, 54511
- CHRU Nancy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FDG PET positive or negative
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of positive or negative amyloid PET
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-A01149-40
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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