Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582199
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Precision Medicine in Alzheimers Disease Integration of Resilience Metrics and Risk Factors - Validation Cohort BioCogBank-AD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Precision Medicine in Alzheimers Disease Integration of Resilience Metrics and Risk Factors - Validation Cohort BioCogBank-AD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BioCogBank-AD
Brief Summary:
BioCogBankAD aims at building a prospective clinical practice cohort of 244 patients with biologically confirmed mild cognitive impairment due to Alzheimers Disease AD or mild AD in order to validate data regarding markers of resilience toward AD pathophysiological process discovered in an upstream project called AD-Resilience
Detailed Description:
Alzheimers disease AD is a leading cause for individual and caregiver burden associated with neurodegenerative diseases NDs in an aging population afflicting 35 million people worldwide and spiraling costs Major advances have been made during the last 20 years in the understanding of AD pathophysiological process It is now well demonstrated that the course of the disease extend over more than 20 years with long pre and pauci-symptomatic periods
A major need and challenge in translational research on Alzheimers disease AD is to predict disease progression rate andor time to clinical conversion notably in the early phases of the AD process such as mild cognitive impairment MCI Current markers such as Aß and tau species measured in cerebrospinal fluid CSF can differentiate AD from control and are currently used in daily clinical practice to assess presence of AD pathological process in patients with cognitive complaints However they do not account for cellular compensation and resistance mechanisms the so-called resilience process
Consequently both prediction of AD progression in single patients and personalized adaptation of management and treatment remain highly limited Moreover there is an important unmet need regarding targeted prevention
AD-Resilience is a translational research study funded by Agence Nationale pour la Recherche ANR and Direction Générale de lOrganisation des Soins DGOS that aims at identifying and validating markers of the biological processes underlying the mechanisms of brain resilience toward AD pathological process Using blood samples the investigators will produce the molecular-profile data that are needed to assess the resilience and brain homeostasis status of patients facing the AD process Results will be processed using high-end machine learning ML to overcome the limitations associated with sub-optimal reliability and precision of dimensional data analysis
These biomarkers will be identified using data and samples from an already available nationwide research cohort BALTAZAR In order to ensure validity and facilitate transfer to clinical practice results from this preliminary study will have to be confirmed in an independent prospective cohort of patients reflecting the full spectrum and real-life heterogeneity of AD
For this purpose BioCogBankAD study aims at building this validation cohort 244 patients with MCI or early dementia due to AD will be recruited in the present study and prospectively followed during three years Blood samples plasma DNA and PaxGen will be taken from these patients in order to measure the biomarkers previously identified in the exploratory study Clinical follow-up including including standardized neuropsychological examination and blood sampling plasma will be performed annually
A major need and challenge in translational research on Alzheimers disease AD is to predict disease progression rate andor time to clinical conversion notably in the early phases of the AD process such as mild cognitive impairment MCI Current markers such as Aß and tau species measured in cerebrospinal fluid CSF can differentiate AD from control and are currently used in daily clinical practice to assess presence of AD pathological process in patients with cognitive complaints However they do not account for cellular compensation and resistance mechanisms the so-called resilience process
Consequently both prediction of AD progression in single patients and personalized adaptation of management and treatment remain highly limited Moreover there is an important unmet need regarding targeted prevention
AD-Resilience is a translational research study funded by Agence Nationale pour la Recherche ANR and Direction Générale de lOrganisation des Soins DGOS that aims at identifying and validating markers of the biological processes underlying the mechanisms of brain resilience toward AD pathological process Using blood samples the investigators will produce the molecular-profile data that are needed to assess the resilience and brain homeostasis status of patients facing the AD process Results will be processed using high-end machine learning ML to overcome the limitations associated with sub-optimal reliability and precision of dimensional data analysis
These biomarkers will be identified using data and samples from an already available nationwide research cohort BALTAZAR In order to ensure validity and facilitate transfer to clinical practice results from this preliminary study will have to be confirmed in an independent prospective cohort of patients reflecting the full spectrum and real-life heterogeneity of AD
For this purpose BioCogBankAD study aims at building this validation cohort 244 patients with MCI or early dementia due to AD will be recruited in the present study and prospectively followed during three years Blood samples plasma DNA and PaxGen will be taken from these patients in order to measure the biomarkers previously identified in the exploratory study Clinical follow-up including including standardized neuropsychological examination and blood sampling plasma will be performed annually
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None