To investigate in an unselected memory clinic sample, the clinical value of 18F]FBB PET in terms of1. change in diagnosis;2. change in level of confidence of diagnosis;3. impact on patient healthcare management.
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome measure is the clinical value of [18F]FBB PET, which will be
operationalized as follows. (i), the change in diagnosis, (ii) change in the
level of confidence in the diagnosis, (iii) the impact on future patient
management as measured using additional ancillary investigations, prescription
of medication and use of health care.
In addition, patients who do not (yet) have dementia (i.e. subjective
complaints, MCI), clinical progression to MCI or dementia during annual
follow-up (based on follow-up visits to neurologist and neuropsychologist) will
serve as additional outcome measure. Furthermore, in a subset of demented
patients we will obtain clinical follow-up to examine the relation with rate of
progression.
Secondary outcome
N.a.
Background summary
In a former study, we studied diagnostic impact of [11C]PIB-PET in a large
group of memory clinic patients. We found that amyloid-PET has a large impact
on diagnosis and the clinicians* confidence in the diagnosis.1 [11C]PIB-PET can
only be used where an on-site cyclotron is available for production, hampering
its widespread implementation. With the development of [18F]-tracers, which do
not require on-site production and are therefore more suitable to be used by
local memory clinics, the question of the diagnostic value in an unselected
patient sample becomes more urgent. In the former study, [11C]PIB-PET was
performed in a selected sample. In the current project, we aim to take the next
step by studying the diagnostic value of an F18 tracer, [18F]Florbetaben
([18F]FBB), in a large and unselected memory clinic sample.
We therefore aim to assess the added clinical value of amyloid-PET scan in a
large and unselected population of patients visiting our memory clinic.
Study objective
To investigate in an unselected memory clinic sample, the clinical value of
18F]FBB PET in terms of
1. change in diagnosis;
2. change in level of confidence of diagnosis;
3. impact on patient healthcare management.
Study design
Prospective and longitudinal, observational study.
Study burden and risks
Risks associated with participation in this study are related to 1) radiation
exposure; 2) idiosyncratic reaction to the tracer; 3) placement of intravenous
catheter; 4) discomfort during scanning.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
1) Patients of the VUmc Alzheimer Center with a written informed consent.;2) Patients of the UMC Utrecht who:
a) visited the Centre of Vascular Cognitive Impairment or
b) Parelsnoer participants.
And were diagnosed with mild cognitieve impairment and provided a written informed consent.
Exclusion criteria
Patients who
- are considered medically unstable (assessed by physician);
- require additional laboratory tests or workup between enrollment and completion of the [18F]FBB PET scan;
- are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant or breast feeding at screening. Females must avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable contraceptive methods such as prescribed birth control or IUD for 24 hours following administration of [18F]FBB;
- are not able to give informed consent (personally or via authorized person) for whatever reason.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-000562-21-NL |
| CCMO | NL50318.029.14 |