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P1‐607: INSIGHTS TO MODEL ALZHEIMER'S PROGRESSION IN REAL LIFE (IMAP): RATIONALE, OBJECTIVE, AND METHODOLOGY
Author(s) -
Risson Valéry,
Tzivelekis Spiros,
Gustavsson Anders,
Bezlyak Vladimir,
Callan Aoife,
Viglietta Vissia,
Lopez-Lopez Cristina,
Graf Ana
Publication year - 2018
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2018.06.620
Subject(s) - repeatable battery for the assessment of neuropsychological status , medicine , cohort , disease , dementia , clinical endpoint , cognition , cognitive decline , longitudinal study , cohort study , neuropsychology , gerontology , physical therapy , clinical trial , psychiatry , pathology
Background: Investigative treatment strategies in Alzheimer’s disease (AD) are now focused on testing disease modifying therapies (DMTs) in pre-dementia stages including subjects at risk of developing AD. The APCC (Alzheimer’s Prevention Initiative Cognitive Composite) and RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) are two sensitive cognitive function scales aimed at tracking changes in pre-dementia AD. In order to better understand the clinical meaningfulness of early APCC and RBANS score changes, disease models are needed to help predict long-term outcomes. The intend of the study is to collect realworld, longitudinal data in order to develop an empirically-derived disease model and to validate the clinical primary endpoint, APCC Test Score and the secondary endpoint, RBANS. Methods: IMAP (Insights to Model Alzheimer’s Progression in real life) is a 5-year, prospective, longitudinal, non-interventional cohort study in AD that intends to collect real-world data to increase the understanding of the disease, help develop robust disease models, and validate the APCC and RBANS instruments. In this non-interventional cohort study, approximately 1300 subjects will be included from ongoing cohort studies across the US and Europe, and will be followed annually for 5 years. Participants (age >60-80 years) will be recruited irrespective of the disease stage and will be categorized by clinical diagnostic group and APOE status. The study should enable simulation of an individual throughout the full spectrum of the disease until death, including early measures of cognitive decline (APCC), APOE genotype, age, biomarkers, cognitive function, functional ability and behavioral symptoms. Results: IMAP will provide an opportunity to better understand the natural history of AD and demonstrate how changes in APCC and RBANS as separate measures of early decline in cognitive function predict long term, clinically meaningful, outcomes or events. Conclusions: This study will provide updated disease progression data on the full continuum of AD that might help better understand the relationship between outcomes in the different disease stages andmodel the individual trajectory over the full AD spectrum.