Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01926249 |
| Other study ID # |
CHUBX 2010/47 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 8, 2011 |
| Est. completion date |
October 29, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
University Hospital, Bordeaux |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
A Multicenter national prospective cohort study including at least 2300 individuals
consecutively recruited from French Research Memory Centers and followed-up over 5 years.
Description:
The increasing incidence of Alzheimer's disease (AD) and related disorders with the change in
the world age demographic is a source of major public health concern. Early and accurate
identification of individuals at high risk of Alzheimer's Disease has become a priority. Over
the last years, research has focused on the concept of "Mild Cognitive Impairment" which
happens to be a heterogeneous condition as, depending on the studies, Mild Cognitive
Impairment patients' conversion rates to dementia range from 2 to 15 percent per year. A
study of the full range of stages of evolution, from preclinical stage, to clinical
expression of dementia or death is therefore of utmost importance to improve our knowledge on
AD and trigger the development of new treatments, especially if between stages transition can
be related to neuroimaging (either structural or molecular), biological (Cerebro-Spinal
Fluid, serum or plasma) or vascular damages markers. However, if all the above markers have
been shown to be individually associated with worsening of cognitive status, no prior study
has simultaneously explored the association of a large panel of risk factors and biomarkers
with the progression through early signs of cognitive impairment until AD in a large sample
of study participants. In parallel to improving the knowledge on AD, it is also important to
better estimate the social and economic burden of AD and their consequences on the
individuals and their circle and how they evolve from early phase (pre-clinical) of the
disease to the most severe stages.
This cohort, solution to the item 29 of the Plan Alzheimer 2008-2012, has been developed
according to the initial memorandum of understanding prepared by the "Comité Plan Cohortes"
of the Fondation Plan Alzheimer, and taking on board comments provided by the Scientific
Advisory Board (July 2010) of the Fondation Plan Alzheimer and the whole working groups
constituted for the preparation of the pilot phase: clinicians, neuro-imaging specialists,
biologists, social sciences researchers (from June 2010). The cohort is built to fulfil the
guiding principles as follows:
- It should be scientifically original and identify hypothesis-driven research, allowing a
corpus of new or confirmatory knowledge of a high-level of evidence to be acquired. In
addition, the infrastructure (standardised collection of socio-demographic, clinical,
imaging, biological data) may allow to respond, in a timely manner, to additional
questions that may emerge over time;
- An interdisciplinary approach is set up as the condition of individuals affected by
neurodegenerative dementias involves clinical and biological aspects but also
environmental, social and economic components;
- While pursuing its own original scientific objectives, the cohort should have the
potential for a comparison with other equivalent cohorts around the world.
This cohort will be including individuals at high risk of developing a neurodegenerative
dementia. As such, the cohort is aiming at providing results with an expected impact for
those individuals of the same profile, as well as their caregivers and their case management.
One expected impact is to increase knowledge on the progression from early signs of cognitive
impairment to AD and estimate associations between these signs and level of biomarkers
assessed through imaging or blood or CSF samples. Another major expected impact is to
standardise and harmonise protocols in terms of clinical and neuro-psychological
examinations, biological markers, neuroimaging markers, diagnosis of dementia, support to
caregivers and informants.
