NCT02263235: PROMARA

In Vivo Alzheimer Proteomics

Terminated NA Last updated 28 December 2021

What this trial tests

NA trial testing administration of stable isotope-labelled leucine- in Probable Alzheimer Disease in 89 participants. Terminated before completion.

Timeline

8 October 2013

Primary endpoint
22 May 2018

22 May 2018

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	89
Start date	8 October 2013
Primary completion	22 May 2018
Estimated completion	22 May 2018
Sites	1 location across France

Drugs / interventions tested

• administration of stable isotope-labelled leucine- — full drug profile →
• collection of CSF, blood, urine, saliva

Conditions studied

• Probable Alzheimer Disease — all drugs for Probable Alzheimer Disease →
• Parkinson Disease — all drugs for Parkinson Disease →
• Neurological Disease Without Cognitive Degradation — all drugs for Neurological Disease Without Cognitive Degradation →
• Brain Trauma — all drugs for Brain Trauma →

Sponsor

University Hospital, Montpellier

Who can join

Adults 55 to 85, any sex, with Probable Alzheimer Disease or Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In France, an estimated 860 000 patients are affected by Alzheimer Disease (AD) which represents, as in other developed countries, a major public health issue. In many cases, AD diagnosis is uncertain and its clinical evolution unpredictable. The exactitude of the diagnosis is however particularly important in the perspective of the validation and use of new therapeutic strategies in AD. Detection of cerebrospinal fluid (CSF) diagnosis biomarkers fell short in the detection, of atypical/mixed cases, of some differential diagnosis, and in differentiating rapid or slow clinical evolutions. Hence, CSF analysis gives a unique opportunity to detect and validate biomarkers in many neurological disorders. Nevertheless, in medical practice, CSF biological analysis is currently limited to a small number of analytes.Quantitative and targeted mass spectrometry, especially operated in the Multiple reaction monitoring mode (MRM), represents an alternative to immunodetection and could be used to detect specific biomarkers in complex matrices such as plasma by specifically discriminating the proteotypic peptides corresponding to each proteins. Mass spectrometry has also the ability to distinguish and quantify isotopically labelled and unlabeled selected targets. This ability was used in a publication by the group of R. Bateman (Washington University, St Louis, USA) who could, after administering stable isotope-labelled leucine, evaluate Ab synthesis and clearance in humans. This approach has an enormous potential to study the metabolism of proteins within the human CNS and consequently help in the understanding and diagnosis of neurological disorders.The main objective of this program is set up a targeted quantitative mass spectrometry method for existing and stable isotope-labelled CSF biomarkers in the neurological field; exploit this approach for diagnostic purpurses and to gain knowledge in the pathophysiology of diseases.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biomarkers in Neurodegenerative Diseases: Proteomics Spotlight on ALS and Parkinson's Disease.
   Raghunathan R, Turajane K, Wong LC. · · 2022 · cited 44× · PMID 36012563 · DOI 10.3390/ijms23169299
2. Modeling the Simultaneous Dynamics of Proteins in Blood Plasma and the Cerebrospinal Fluid in Human <i>In Vivo</i>.
   Giroux P, Vialaret J, Kindermans J, Gabelle A, et al · · 2024 · cited 2× · PMID 38857467 · DOI 10.1021/acs.jproteome.4c00059
3. Enabling population protein dynamics through Bayesian modeling.
   Lehmann S, Vialaret J, Gabelle A, Bauchet L, et al · · 2024 · PMID 39078204 · DOI 10.1093/bioinformatics/btae484