The Vallecas Project

Initial assessment

Before entering the study, volunteers interested in participating underwent an initial assessment to determine whether they met the four inclusion criteria (signing an informed consent form, being between 70 and 85 years of age, availability and ability to travel to the Alzheimer Centre for visits, as well as visual and hearing abilities that would allow the study assessments to be carried out).

In addition, a series of exclusion criteria were established, including the following:

• Suspicion or diagnosis of dementia
• Inability to perform neuroimaging studies
• Alcohol abuse
• Mental retardation
• History of certain psychiatric or neurological diseases (e.g. schizophrenia, stroke, severe head injury, central nervous system infections, uncorrected vitamin deficiencies, etc.).

Socio-demographic profile

The following personal data were collected during the baseline visit by means of a structured interview: sex, educational level, marital status, number of children, type and amount of income, main occupation, sleep habits, social relations, diet, physical exercise, hobbies and leisure activities, etc.

In addition, volunteers are also asked to fill in an annual quality of life and subjective well-being scale (mobility, self-care, daily activities, pain/discomfort, anxiety/depression, perception of health status).

Clinical assessment

At each visit, relevant information is collected from each volunteer by means of a semi-structured clinical interview:

• Vascular risk factors
• Neurological history
• Habitual alcohol consumption
• Psychiatric pathology
• Other relevant systemic diseases
• Family history
• Usual pharmacological treatment

General examination

All volunteers undergo a standardised general and neurological examination at each visit, which includes: cranial nerves, muscle balance, coordination, extrapyramidal system, gait, osteotendinous reflexes, midline release reflexes, etc. Special attention is paid to parameters such as alterations in gait, manual writing or instrumental activities of daily living.

Neuropsychological exploration

The neuropsychological protocol has been designed with the aim of comprehensively assessing the cognitive profile of the study participants.

Based on the application of different measurement instruments (screening and cognitive assessment tests, scales and questionnaires), information is collected annually on both global neuropsychological functioning and specific cognitive processes, with special emphasis on information processing speed, attention, episodic memory, language, visuo-construction and executive functions. In addition, the neuropsychological study is completed with a self-reported questionnaire of subjective memory complaints, a scale to assess the performance of instrumental activities of daily living and other scales to assess anxious and depressive symptomatology.

Determination of biomarkers

It is now widely accepted that the molecular changes associated with AD, including the formation of amyloid plaques and neurofibrillary tangles, begin many years before the onset of clinical symptoms. In recent years, the scientific community has shown great interest in the development of new AD biomarkers and their usefulness in risk assessment and early diagnosis of the disease. Thus, in the Vallecas Project, blood samples are collected for the study of a series of genetic and biochemical markers.

On the other hand, the blood samples and derivatives collected will be used for the determination of a series of biochemical markers.

The usefulness of these biomarkers is complementary to the information derived from the study of genetic risk markers already mentioned and may define risk factors already revealed in previous studies.

Neuroimaging studies

Knowledge of the morphological variations that occur in brain structure throughout life is essential to assess the corresponding pathological changes that occur in neurodegenerative diseases. In this context, neuroimaging techniques such as Magnetic Resonance Imaging (MRI) have enabled important advances in the understanding of age-related brain changes.

MRI is a non-invasive tool that allows the study of normal ageing in individuals at different points in their lives. However, conventional MRI techniques are unable to detect and quantify age-dependent microstructural changes that have been described in post-mortem studies of brain tissue. Consequently, the project aims to conduct a series of studies based on various modern MRI techniques that can provide volumetric quantitative indices of morphological changes.

Featured publications