Alzheimer's Disease, Mild Cognitive Impairment, PET, florbetaben, dementia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All patients presenting at VUmc memory clinic will be invited to participate in the study.
Exclusion criteria
Exclusion criteria: Patients who - are mentally incompetent - 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 for whatever reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |