Page 70 - Memora anual Fundación CIEN 2015

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