Amyloid PET Imaging Clinical Trial
— MAFOfficial title:
18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study
| Verified date | May 2019 |
| Source | Central Hospital, Nancy, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | November 2017 |
| Est. primary completion date | November 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 / Aß40 normal (Ab42 / Aß40 > 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU Nancy | Vandoeuvre les Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Central Hospital, Nancy, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | number of positive or negative amyloid PET | 2 years |