Primary objective:1. To investigate the clinical value of [18F]Flutemetamol PET in memory clinic patients and especially those with suspicion of young onset dementia in terms ofa. change in (level of confidence of) diagnosis;b. impact on patient…
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Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome measure is the clinical value of [18F]Flutemetamol PET, which
can be subdivided into four outcome measures. First, the change in (the level
of confidence in) the diagnosis as assessed by the clinician after the
disclosure of the PET results will be measured. Secondly, the impact on future
patient management as measured using additional ancillary investigations,
prescription of medication and use of health care will be measured. Third, the
diagnostic accuracy for final diagnosis defined by a consensus panel of
clinicians at 2 years follow-up (used as a reference diagnosis) will be
estimated. Fourth, cost-effectiveness will be assessed using questionnaires
that enables quality of life and care related costs calculation.
Secondary outcome
The concordance of [18F]Flutemetamol PET with CSF markers (A* 1-42, total tau
and p-tau 181) and MRI markers (atrophy medial temporal lobe) will be assessed
by binary rating (e.g. *normal* or *abnormal*) for each of these measures.
Furthermore, the prognostic value of [18F]Flutemetamol will be measured using
(repeated) cognitive measures (Mini Mental State Examination (MMSE) and the
Cambridge Cognitive Test (CAMCOG)) obtained at baseline and at 1 and 2 year
follow-up.
Background summary
Neuropathologically, Alzheimer*s Disease (AD) is characterized by amyloid
plaques and neurofibrillary tangles. Development of the positron emission
tomography (PET) tracer [11C]Pittsburgh compound-B ([11C]PIB) has for the first
time enabled the visualization of amyloid-beta (A*) in vivo, and evidence shows
high sensitivity and specificity in separating AD from controls.
However, [11C]PIB-PET can only be used where an on-site cyclotron is available
for production, hampering it*s widespread implementation. [18F]-tracers, which
do not require on-site production are therefore more suitable to be used by
many more centers and enable studying the discriminatory value in the
diagnostic setting. Recently, [18F]Flutemetamol has become available for study.
Study objective
Primary objective:
1. To investigate the clinical value of [18F]Flutemetamol PET in memory clinic
patients and especially those with suspicion of young onset dementia in terms of
a. change in (level of confidence of) diagnosis;
b. impact on patient healthcare management;
c. diagnostic accuracy of final diagnosis at 2 years follow-up;
d. cost-effectiveness.
Secondary objectives:
1. To assess the concordance of [18F]Flutemetamol PET with established
biomarkers acquired from CSF (A* 1-42, total tau and p-tau 181) and MRI
(atrophy medial temporal lobe);
2. To assess the prognostic value of [18F]Flutemetamol PET.
Study design
This is an observational open study.
Study burden and risks
Risks associated with participation in this study are related to 1) radiation
exposure; 2) idiosyncratic reaction to the tracer; 3) placement of an
intra-venous catheter; 4) discomfort during scanning.
1) Administration of 185 MBq [18F]Flutemetamol will result in a whole body
effective dose of 3.5 mSv according to the GE-067study (see IB Edition 6/
March 2012). For comparison, the natural background radiation dose in the
Netherlands gives an annual dose of 2 - 2.5 mSv. Thus, the total radiation
exposure of the total PET procedure is within an acceptable range of a yearly
(unnatural) radiation exposure with a maximum of 10 mSv. In case of previous
exposure to radioactivity, subjects will be eligible if the yearly cumulative
dose due to exposure to radiation remains below 10 mSv.
2) Idiosyncratic reaction to the tracer
The injected mass of [18F]Flutemetamol PET used in this study is negligible.
[18F]Flutemetamol PET is a radiotracer that have been used in humans. Side
effects have never been reported at the tracer doses used in PET studies. A
physician will be available during each injection of the radiotracer.
3) Intravenous cannulation
There is a very small risk of infection and bleeding associated with
intravenous catheters, which are prevented by proper techniques.
4) Discomfort during scanning
It may be uncomfortable to lie motionless in the cameras (both PET and MRI) and
it may cause some subjects to feel anxious. Subjects will be made acquainted
with the surroundings beforehand. Our staff will be available to provide
support, reduce anxiety, optimise the comfort of the subject and remove the
subject from the scanner if requested.
De Boelelaan 1118
Amsterdam 1081HZ
NL
De Boelelaan 1118
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
- Written informed consent;
- age *80 years;
- weight >50 kg;
- Mini Mental State Examination score * 18.
Exclusion criteria
Patients who
- are considered medically unstable;
- require additional laboratory tests or workup between enrolment and completion of the PET scan;
- are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days prior to the PET scan;
- have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, *-secretase or *-secretase inhibitor) unless it can be documented that the subject received only placebo during the course of the trial;
- 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 (negative serum *-hCG at the time of screening and negative urine *-hCG on the day of imaging) 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]Flutemetamol;
- are claustrophobic;
- have abnormalities on MRI, other than white matter changes or an incidental small lacunar lesion, which may affect visual reading of Flutemetamol PET.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-002303-18-NL |
| CCMO | NL39995.029.12 |
| OMON | NL-OMON24675 |