Clinical trial NCT02016352: Cerebrospinal Fluid Proteome in Hydrocephalus
Official title: Cerebrospinal Fluid Proteome in Hydrocephalus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Pressure Hydrocephalus
Keywords: hydrocephalus
proteomic
cerebrospinal fluid
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: PROLIPHYC is a collaborative prospective study that aims at discovering deep cerebrospinal fluid (CSF) proteome with a new clinically-compatible proteomics strategy, in a cohort of 100 patients suspected of neurodegenerative diseases and/or normal pressure hydrocephalus.

Detailed description: CSF proteome is the real time protein content that may reveal useful biomarkers for diagnosis and therapeutic decision-making. But the low protein concentration in CSF and the low volumes typically obtained after lumbar puncture precludes the conventional use of proteomic analysis. We miniaturized the method to be compatible with low-volume samples by combination of nanoLC-MS/MS analysis and combinatorial peptide ligand library technology to reduce the dynamic range of protein concentration in CSF and unmask previously undetected proteins. We demonstrated that this deep proteomic analysis allows profiling the CSF proteome with a reasonable depth, in short analytical times and good accuracy. We settled a clinically-compatible proteomics strategy targeting the deep CSF proteome discovery.

The PROLIPHYC study is a prospective study that aims at analysing CSF proteome with our new strategy in a cohort of patients suspected of normal pressure hydrocephalus and/or related neurodegenerative diseases. The PROLIPHYC project combines detailed clinical and neuropsychological evaluation, gait analysis, MRI brain imaging, lumbar CSF dynamics and deep proteome. We hypothesize in the PROLIPHYC study that a specific cluster of polypeptides can be associated with Alzheimer disease, vascular dementia and normal pressure hydrocephalus profiles. Validating this hypothesis might be a significant step towards a proteomic lexicon of aging brain, neurodegenerative diseases and dementia.

Neurosciences department and Alzheimer disease centre from the Toulouse University Hospital are both involved in this project. The deep proteomic study is performed in Toulouse by the Institute of Pharmacology and Structural Biology with the academic support of the Institute of Mathematics of Toulouse.

Eligibility criteria: Inclusion Criteria:

* Gait problems, cognitive decline, urinary incontinence and enlarged ventricles on imaging

Exclusion Criteria:

* Psychiatric disorders
* Lumbar punction contraindication
* RMI contraindication

Primary outcomes:
measure: CSF proteome measure
timeFrame: 48 hours
Secondary outcomes:
measure: correlation between CSF proteome and gait analysis
timeFrame: 72 hours
measure: correlation between CSF proteome and MRI brain imaging
timeFrame: 72 hours
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Eric SCHMIDT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bech-Azeddine R, Hogh P, Juhler M, Gjerris F, Waldemar G. Idiopathic normal-pressure hydrocephalus: clinical comorbidity correlated with cerebral biopsy findings and outcome of cerebrospinal fluid shunting. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):157-61. doi: 10.1136/jnnp.2006.095117. Epub 2006 Sep 29.