Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05640141 |
Other study ID # |
PRESAGE |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 26, 2022 |
Est. completion date |
December 30, 2024 |
Study information
Verified date |
December 2021 |
Source |
University Hospital, Caen |
Contact |
Leslie M. Decker, PhD |
Phone |
06.70.40.58.44 |
Email |
leslie.decker[@]unicaen.fr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The main aim of the study is to characterize and understand the pathological mechanisms
underlying the motoric cognitive risk syndrome, which is a predictor of Alzheimer disease.
Description:
Alzheimer's disease (AD) is affecting more than 46.8 million people worldwide, making
dementia one of the greatest public health challenges of the 21st century. The progression of
AD is slow with a presymptomatic course over several years to decades, during which
pathophysiological changes are underway, but the disease has not yet caused any noticeable
symptoms to warrant a clinical diagnosis. A strong effort is ongoing to identify biomarkers
preceding cognitive decline that can aid diagnosis and early intervention. Criteria for the
motoric cognitive risk syndrome (MCR), including subjective cognitive decline (SCD) and
slower preferred walking speed, but otherwise normal functioning, are powerful risk
indicators of developing cognitive impairment and dementia. The presence of MCR is associated
with a more than three-fold risk of developing dementia while the risk is only two-fold for
SCD or slow gait alone. However, the pathophysiology of MCR is unknown and getting into the
processes that cause such condition is needed to complement the MCR-based criteria and
increase their predictive validity of cognitive decline and dementia. Impaired attentional
control related to white matter alterations of presumed vascular origin may be responsible
for the MCR phenotype. Individuals with SCD exhibit loss of white matter integrity in brain
regions typically involved in attentional control, and abnormally slow gait has been linked
to the disruption of white matter tracts associated with executive attention. Furthermore, a
deeper understanding of MCR requires considering not only regional white matter changes but
also the individuals' cognitive capacity to cope with brain damages, namely the cognitive
reserve. Hence, the PRESAGE project intends to evaluate the interplay of white matter
integrity and cognitive reserve on attentional control in MCR and non-MCR individuals aged 60
or older. Attentional control will be explored at both the behavioral and brain levels using
dual-task challenges where individuals will have to divide attention between a cognitive
(stroop) task and a motor task (walking). The working hypothesis is that the dual-task cost -
a proxy of attentional control - is predictive of white matter abnormalities which, when
adjusted for cognitive reserve, age and sex, should discriminate between MCR and non-MCR
individuals. The project also includes a prospective, longitudinal study (two-year follow-up)
whose purpose is to determine whether this marker, alone or in combination with other
potentially relevant markers (i.e., neuropsychological, functional and chronobiological),
have predictive value for conversion from MCR to mild cognitive impairment and dementia.
Findings will increase knowledge about the pathophysiology of MCR and will contribute to
improve MCR criteria and early identification of at-risk individuals.