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The ABIDE-PET study.


- candidate number21278
- NTR NumberNTR5026
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jan-2015
- Secondary IDs2014.483 NL50318.029.14
- Public TitleThe ABIDE-PET study.
- Scientific TitleAmyloid-PET as a diagnostic marker in daily practice.
- ACRONYMABIDE-PET
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedAlzheimer, Mild Cognitive Impairment, PET scan, Florbetaben, Dementia
- Inclusion criteriaAll patients presenting at VUmc memory clinic will be invited to participate in the study.
- Exclusion criteriaPatients 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-jan-2015
- planned closingdate1-jan-2017
- Target number of participants500
- InterventionsFlorbetaben PET-scan.
- Primary outcomeThe 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 outcomeIn 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.
- TimepointsN.a.
- Trial web siten.a.
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD Arno de Wilde
- CONTACT for SCIENTIFIC QUERIESMD Arno de Wilde
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Piramal Imaging
- Publicationsn.a.
- Brief summarySUMMARY
Rationale
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.

Primary 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 population: Unselected patient population of n=500 subjects visiting the memory clinic of the VUmc Alzheimer center.

Intervention (if applicable): [18F]FBB PET scan.

Main study parameters/endpoints:
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. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.
- Main changes (audit trail)15-april-2015: Wijziging titel trial:

Old: "the Florbateben study"

New: The ABIDE-PET study.
- RECORD5-jan-2015 - 15-apr-2015


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