Development of a prediction model of conversion to Alzheimer's disease in people with mild cognitive impairment: the statistical analysis plan of the INTERCEPTOR project.
Alzheimer’s disease
Biomarker
Dementia
Longitudinal study
Mild cognitive impairment
Prediction model
Statistical analysis plan
Journal
Diagnostic and prognostic research
ISSN: 2397-7523
Titre abrégé: Diagn Progn Res
Pays: England
ID NLM: 101718985
Informations de publication
Date de publication:
25 Jul 2024
25 Jul 2024
Historique:
received:
07
12
2023
accepted:
13
06
2024
medline:
26
7
2024
pubmed:
26
7
2024
entrez:
25
7
2024
Statut:
epublish
Résumé
In recent years, significant efforts have been directed towards the research and development of disease-modifying therapies for dementia. These drugs focus on prodromal (mild cognitive impairment, MCI) and/or early stages of Alzheimer's disease (AD). Literature evidence indicates that a considerable proportion of individuals with MCI do not progress to dementia. Identifying individuals at higher risk of developing dementia is essential for appropriate management, including the prescription of new disease-modifying therapies expected to become available in clinical practice in the near future. The ongoing INTERCEPTOR study is a multicenter, longitudinal, interventional, non-therapeutic cohort study designed to enroll 500 individuals with MCI aged 50-85 years. The primary aim is to identify a biomarker or a set of biomarkers able to accurately predict the conversion from MCI to AD dementia within 3 years of follow-up. The biomarkers investigated in this study are neuropsychological tests (mini-mental state examination (MMSE) and delayed free recall), brain glucose metabolism ([ This paper contains a detailed description of the statistical analysis plan to ensure the reproducibility and transparency of the analysis. The prognostic model developed in this study aims to identify the population with MCI at higher risk of developing AD dementia, potentially eligible for drug prescriptions. The nomogram could provide a valuable tool for clinicians for risk stratification and early treatment decisions. ClinicalTrials.gov NCT03834402. Registered on February 8, 2019.
Sections du résumé
BACKGROUND
BACKGROUND
In recent years, significant efforts have been directed towards the research and development of disease-modifying therapies for dementia. These drugs focus on prodromal (mild cognitive impairment, MCI) and/or early stages of Alzheimer's disease (AD). Literature evidence indicates that a considerable proportion of individuals with MCI do not progress to dementia. Identifying individuals at higher risk of developing dementia is essential for appropriate management, including the prescription of new disease-modifying therapies expected to become available in clinical practice in the near future.
METHODS
METHODS
The ongoing INTERCEPTOR study is a multicenter, longitudinal, interventional, non-therapeutic cohort study designed to enroll 500 individuals with MCI aged 50-85 years. The primary aim is to identify a biomarker or a set of biomarkers able to accurately predict the conversion from MCI to AD dementia within 3 years of follow-up. The biomarkers investigated in this study are neuropsychological tests (mini-mental state examination (MMSE) and delayed free recall), brain glucose metabolism ([
DISCUSSION
CONCLUSIONS
This paper contains a detailed description of the statistical analysis plan to ensure the reproducibility and transparency of the analysis. The prognostic model developed in this study aims to identify the population with MCI at higher risk of developing AD dementia, potentially eligible for drug prescriptions. The nomogram could provide a valuable tool for clinicians for risk stratification and early treatment decisions.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT03834402. Registered on February 8, 2019.
Identifiants
pubmed: 39049042
doi: 10.1186/s41512-024-00172-6
pii: 10.1186/s41512-024-00172-6
doi:
Banques de données
ClinicalTrials.gov
['NCT03834402']
Types de publication
Journal Article
Langues
eng
Pagination
11Subventions
Organisme : Agenzia Italiana del Farmaco, Ministero della Salute
ID : AIFA extraordinary funds for the institutional activity
Investigateurs
Maurizio Belfiglio
(M)
Cristina Muscio
(C)
Davide Quaranta
(D)
Emanuele Cassetta
(E)
Mario Barbagallo
(M)
Carlo Gabelli
(C)
Simona Luzzi
(S)
Fulvio Lauretani
(F)
Innocenzo Rainero
(I)
Carlo Ferrarese
(C)
Orazio Zanetti
(O)
Michela Marcon
(M)
Flavio Mariano Nobili
(FM)
Giuseppe Pelliccioni
(G)
Sabina Capellari
(S)
Elena Sinforiani
(E)
Gioacchino Tedeschi
(G)
Carmen Gerace
(C)
Laura Bonanni
(L)
Sandro Sorbi
(S)
Lucilla Parnetti
(L)
Informations de copyright
© 2024. The Author(s).
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