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• To get experience in the implementation of The participant recruitment phase for the Vallecas
the different elements of the protocol and to project lasted from October 2011 to December
estimate the burden of the evaluator and the 2013. By then, a total of 1,213 individuals of both gen-
evaluated. ders, aged 70-85 years were recruited and evalua-
ted at baseline. Once included in the study, the
• To promote the Project to achieve the project conducts an annual follow-up for five years
participation of volunteers and attracting in order to assess the evolution profile of all partici-
enough funds to carry out the Vallecas pants, specifically identifying those that develop
Project. cognitive impairment and/or dementia. At the end
of 2015, we are at the end of the third visit for the en-
A total of 175 volunteers were involved in this phase tire cohort and about the middle of the fourth visit
of the project, of which: (see figure in section 1.3 of this Report).
• 95 people were able to participate in the 4.3.1. Baseline evaluation
project.
Before entering the study, volunteers interested in
• 80 people were unable to participate participating in it were subjected to an initial assess-
because they met at least one exclusion ment to determine whether they meet the criteria
criterion. for inclusion and/or whether an exclusion criterion
exists. Overall, all volunteers were required to meet
4.3. The Vallecas Project four inclusion criteria in order to be considered for
entering the study:
Following the completion and analysis of the pilot
study the protocol was amended based on the ex- • Signing an informed consent.
perience gained and a volunteer recruitment stra- • Be aged between 70 and 85 years old.
tegy was established (social awareness campaign • Availability and ability to reach the Alzheimer
in the media, visits to centers for seniors, contact
pensioner's organizations, etc.). In September 2011, Centre for visits.
after the "Global Summit on Alzheimer Disease Re- • Visual and hearing abilities that allow
search" held in Madrid and with the financial support
of the Queen Sofia Foundation. conducting the study tests.
The Vallecas Project is being carried out in the In addition, a number of exclusion criteria were es-
Queen Sofia Foundation Alzheimer Center Research tablished, including the following: i) suspected or
Unit by researchers from the CIEN Foundation (Car- diagnosed dementia; ii) inability to perform neuroi-
los III Institute of Health). It aims to develop a proba- maging studies; iii) alcohol abuse; iv) mental retar-
bilistic algorithm to identify individuals at risk dation; or v) history of certain psychiatric or
for AD-type dementia over the course of a few neurological diseases (eg schizophrenia, stroke, se-
years. Such an algorithm will be based on a combi- vere head trauma, Central nervous system infec-
nation of socio-demographic, historical, clinical, tions, uncorrected vitamin deficiencies, etc.
neurological and neuropsychological, biological
(from blood tests) and neuroimaging (various forms In the table below some global data from the co-
of 3T MRI). hort of approximately 1,213 individuals evaluated to
date are indicated.
CIEN Foundation Annual Report 2015 / 72