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The ABIDE-PET study.

Amyloid-PET as a diagnostic marker in daily practice.

Status
Recruiting
Phases
Unknown
Study type
Unknown
Source
NL-OMON
Registry ID
NL-OMON21592
Enrollment
500
Registered
2015-01-05
Start date
2015-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Alzheimer's Disease, Mild Cognitive Impairment, PET, florbetaben, dementia

Interventions

Florbetaben PET-scan.

Sponsors

VU Medical Center.
Lead Sponsor

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

MeasureTime 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

MeasureTime 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.

Contacts

Public ContactArno de Wilde
a.dewilde@vumc.nl+31204440685

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)