Novel diagnostic approaches for the diagnosis of Alzheimer's Disease: Technology assessment and clinical effectiveness.

Many diagnostic procedures have been developed and applied on patients with
dementia, in which most diagnoses are based on clinical judgment and
neuropsychological testing. In recent years, many efforts have been made to
develop more accurate and less time consuming biotechnical diagnostics,
including brain imaging (MRI, PET) and markers in CSF. These diagnostics
however, are not recommended as part of the routine workup for people with
suspected dementia. Furthermore, the diagnostic added-value of these techniques
has not been established yet. There needs to be an economic model to validate
and assess the accuracy, quality of life and costs of those new techniques.
Moreover, costs and benefits of these tests need to be compared with the tests
of the current clinical standard, and besides that, the model should take into
account the advantages of an earlier diagnosis with relation to Alzheimer*s
disease.

The general objective is to validate and assess the clinical and economic
added-value of a) innovative diagnostic tests developed in WP1 (PET tracers),
WP2 (ultra high field MRI) and WP3 (CSF), and b) other emerging diagnostic
tests for Alzheimer's Disease vis-a-vis the diagnostic work-up that is the
current clinical standard, and c) to develop a 'decision analytic model' that
can be used to integrate the data from a) and b).

Prospective cohortstudy.
The regular diagnostics of patients visiting the memoryclinics is arranged in a
way that the data, which are gathered in a standardized manner during the
diagnostic process, are unambiguously saved. This enables exchange of data
between the participating Academic Medical Centres (UMC's). In consultation
with each other, the responsible participants of those UMC's have established a
minimal dataset, to be registered at some specified moments in time (baseline
and follow-up). This dataset consists of data that already are collected during
the common healthprocess, but not always in a standardized way. The
standardisation is about both the way data are collected and of registering it
in a database. Even though the type of healthcare remains the same, it might be
necessary to adjust the organisation of the healthcare pathway to meet the
needs of standardisation.
The gathering of data will be prospective and (in part) longitudinal, with a
follow-up once a year. Expectation is that inclusion will start in 2009, with
an open end.
Additional liquor (3ml) will be gathered and registered in a biobank, adapted
to the regular acquisition of bodily material as much as possible. This
additional material will be collected during baseline. It will be centrifuged,
... (uitgevuld in 0.5ml cryovials) and stored by a temperature of -80 degrees
Celcius. The bodily material will be encoded and stored in the biobanks of the
participating UMC's.

Liquor: there is great vagueness about the involved risk of lumbal punctures.
However, this risk seems to be considerably negligible, as it turns out that
with the use of a thin a-traumatical needle the chance of getting a
postpunctional headache (the most probable complication) is reduced to less
than 10%. The amount of liquor that is taken is of no account, as long as it
remains less than 30ml. Patients suffering from Alzheimer's Disease or mild
cognitieve impairments even show a smaller risk, that is, less than 2%.
Moreover, they also seem to be less troubled by pain during the puncture. Other
complications like meningitis and subdural spinal haematoma are extremely
uncommon (Peskind ER, Alz Dis Assoc Disord 2005; 19:220-225).
MRI: patiens and caregivers will not be exposed to invasive methods or other
risky cirumstances. MRI scans are performed mainly as part of the regular
healthcare package.