Loading clinical trials...
Loading clinical trials...
Cholinergic Markers as Predictive Tools of Therapeutic Response in Alzheimer's Disease (CHOLINE)
Several previous studies have assessed acetylcholine (Ach) and acetylcholinesterase activity (AchE-a) levels in Alzheimer's disease (AD) pathophysiology. The cerebrospinal fluid (CSF) Ach level was significantly decreased in AD patients, and correlated positively with dementia score and MMSE (1, 2). Two studies have demonstrated positive correlations between CSF AchE-a and CSF Tau, phosphorylated-Tau (P-Tau) and AB 1-42 peptide (3,4). ChEIs (cholinesterase inhibitors) have been approved for the treatment of AD but only 20 to 30 % of patients are responders (5). Any consistent data allow the clinician to predict the response to the treatment. The link between basal cholinergic status and ChEIs efficiency has never been done. Even if, there is a wild research in AD treatment, ChEIs or treatment acting on the Ach pathways will remain a long time valuable treatment particularly in moderate AD in which disease modifying therapies did not show any efficiency. The investigators's objective is to prospectively explore the predicting value of CSF Ach and AchE-a levels on ChEIs response in AD patients.
Strategy: Within the framework of the usual management, the investigators propose the protocol to patients who had an assay of the CSF biomarkers with a CSF AD biological profile before the introduction of an IChEs and having accepted Their CSF will stocked in our biobank. Patients will only have additional neuropsychological assessments. The rest of the care comes under the current care. The quantification of ACh in the CSF will be performed in tandem mass spectrometry after separation by liquid chromatography (LC-MS / MS). AChE activity will be determined by colorimetric determination. The investigators's objective is to prospectively explore the predicting value of CSF Ach and AchE-a levels on ChEIs response in AD patients. The evaluation criteria will be * Difference of the mean value of the ACh level and AChE activity in the CSF between the responder and non-respondier groups of patients. * "Responder" patients are defined by an improvement of at least 4 points on the ADAS-Cog (cognitive part) ADAS-Cog after 6 months of treatment. * "Non-responders" are defined as aggravation, lack of improvement or improvement \<4 points on the ADAS-Cog scale.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
Centre Mémoire de Ressources et de Recherche Paris Nord
Paris, France
Start Date
November 8, 2017
Primary Completion Date
January 12, 2021
Completion Date
January 12, 2021
Last Updated
February 18, 2021
100
ACTUAL participants
ADASCog
DIAGNOSTIC_TEST
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
NCT04123314
NCT07178210
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions