Amyloid-PET as a diagnostic marker in daily practice.

Recruiting

Conditions: Alzheimer's disease
Dementia
10042258

Registration Number: NL-OMON44936

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 516

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome measure is the clinical value of [18F]FBB PET, which will be<br /><br>operationalized as follows. (i), the change in diagnosis, (ii) change in the<br /><br>level of confidence in the diagnosis, (iii) the impact on future patient<br /><br>management as measured using additional ancillary investigations, prescription<br /><br>of medication and use of health care.<br /><br>In addition, patients who do not (yet) have dementia (i.e. subjective<br /><br>complaints, MCI), clinical progression to MCI or dementia during annual<br /><br>follow-up (based on follow-up visits to neurologist and neuropsychologist) will<br /><br>serve as additional outcome measure. Furthermore, in a subset of demented<br /><br>patients we will obtain clinical follow-up to examine the relation with rate of<br /><br>progression.</p><br>

Secondary Outcome Measures