Back to results18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study (MAF)
Primary Purpose
Amyloid PET Imaging
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
18F-Florbetaben PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Amyloid PET Imaging
Eligibility Criteria
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.
Sites / Locations
- CHRU Nancy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FDG PET positive or negative
Arm Description
Outcomes
Primary Outcome Measures
number of positive or negative amyloid PET
Secondary Outcome Measures
Full Information
NCT ID
NCT02556502
First Posted
September 21, 2015
Last Updated
May 3, 2019
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT02556502
Brief Title
18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study
Acronym
MAF
Official Title
18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloid PET Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FDG PET positive or negative
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
18F-Florbetaben PET
Primary Outcome Measure Information:
Title
number of positive or negative amyloid PET
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHRU Nancy
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
12. IPD Sharing Statement
Learn more about this trial
18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study
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