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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02556502
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : August 11, 2017
Information provided by (Responsible Party):
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

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)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
Experimental: FDG PET positive or negative Device: 18F-Florbetaben PET

Primary Outcome Measures :
  1. number of positive or negative amyloid PET [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02556502

Contact: Antoine VERGER, AHU 03 83 15 51 48

CHRU Nancy Recruiting
Vandoeuvre les Nancy, France, 54511
Contact: VERGER Antoine, AHU         
Sponsors and Collaborators
Central Hospital, Nancy, France

Responsible Party: Central Hospital, Nancy, France Identifier: NCT02556502     History of Changes
Other Study ID Numbers: 2015-A01149-40
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Proteostasis Deficiencies
Metabolic Diseases