Amyloid-PET as a diagnostic marker in daily practice.

Amyloid-PET as a diagnostic marker in daily practice. - ABIDE-PET

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44936

Enrollment

516

Registered

2014-12-18

Start date

2015-01-26

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's disease Dementia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 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. 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.	—

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. 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

Measure	Time frame
N.a.	—

Countries

Netherlands

Outcome results