Parkinson's Disease Clinical Trial
Official title:
Predictive and Diagnostic Value of Tau and Beta-amyloid Markers in Cerebrospinal Fluid and Positron Emission Tomography in the Dementia of Parkinson's Disease
The PET tracer Fluoro-ethyl-methyl-amino-naphthyl-ethylidene-malononitrile ([F18]-FDDNP) has
a specific affinity for lesions containing tau protein and beta-amyloid The study consists
of two phases
- In a first transversal phase, 8 neurologically unimpaired controls, 15 patients with PD
and no dementia (PDND) and 8 with PD and dementia (PDD) will undergo lumbar puncture
for study of tau, phospho-tau and beta-amyloid levels in cerebrospinal fluid (CSF), as
well as positron emission tomography (PET) with ([F18]-FDDNP. Concentration of CSF
markers and both the degree and topography of FDDNP-PET uptake will be compared among
groups, along with correlation analysis between CSF and PET findings.
- During the second phase (18 months follow-up), the PDND patients will undergo the same
procedures, and cognitive changes including incident dementia will be assessed. The
correlation between cognitive impairment and neurochemical and neuroimaging changes
will be established to determine the predictive value of these markers.
Since the pathological lesions observed in Alzheimer disease (AD) are common in the PD and
the concentrations of tau and beta-amyloid are altered in AD and PET with [F18]-FDDNP is
able to separate patients with AD and cognitive impairment from controls, we hypothesized
that:
1. - Patients with PD will show a biomarkers profile similar to the AD (decreased levels
of beta-amyloid and increased phospho-tau and tau) in CSF, and an abnormal uptake of
[F18]-FDDNP PET compared to PDND patients and controls.
2. -The distribution of cortical [F18]-FDDNP in the PD will be different from the AD and
similar to dementia with Lewy bodies, predominantly in posterior cortical areas.
3. PDND patients will show a [F18]-FDDNP PET uptake and levels of protein markers in CSF
intermediate between controls and patients with PD.
4. -In the subsequent follow-up, PDND patients will show cognitive impairment correlate to
changes in the levels of protein markers in CSF and uptake of PET with [F18]-FDDNP
5. - The predictive value for the development of dementia in PD of specific patterns of
PET uptake and CSF proteins profile will be established.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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