An observational study in Cognitive Dysfunction, sponsored by Instituto de Salud Carlos III. Recruiting at 8 sites in Spain. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-01-11.
Sponsored by Instituto de Salud Carlos III · Observational
The goal of this observational study is to use the combined power of the integration of clinical, molecular, proteomic, genomic, care, social, environmental and behavioural data in patients, using advanced artificial intelligence techniques for data processing and analysis, in order to generate predictive models for the preclinical detection of CI in the population aged 55-70 years.
The "Comprehensive Plan for Alzheimer's and other Dementias" shows that more than 50% of cases of cognitive impairment (CI) in population-based studies are undetected. The figure is particularly striking in the case of mild dementias, of which up to 90% are undiagnosed. The aim is to use the combined power of the integration of clinical, molecular, proteomic, genomic, care, social, environmental and behavioural data in patients, using advanced artificial intelligence techniques for data processing and analysis, in order to generate predictive models for the preclinical detection of CI in the population aged 55-70 years.
Multicentre, non-interventional, convergent mixed methods observational study, with a prospective observational design part and a qualitative design part. Sample recruited randomly among users of the public health system in the participating geographical locations. Data will be collected in 6 regions (Andalucia, Castilla-Mancha, Catalonia, Valencia, Madrid and the Basque Country) and their rural and urban Primary Care (PC) networks.
Non-institutionalised subjects, aged between 55 and 70 years, assigned to PC centres in the territories included in the study, with a "living history" (recorded in the last 12 months) and without an established diagnosis of CI.
A descriptive analysis of the characteristics of the population will be carried out using frequencies and percentages or measures of central tendency and dispersion, with their 95% confidence intervals. Baseline socio-demographic and clinical characteristics will be compared in order to study the homogeneity of the sample. For the comparison of qualitative variables, the Chi-square test or Fisher's exact test will be used and for the comparison of quantitative variables, the t-test or Wilcoxon test will be used. Logistic regression models are proposed to analyse health outcome factors associated with mild cognitive impairment. All models will include repeated measures for each individual. All models will adjust for different risk factors, and for those factors that may change over time, the interaction between time and that factor will be studied.
Initially, multivariate linear latent models will be used for the predictive model of cognitive impairment risk. The integration of data from multiple sources of information will be done using multivariate probabilistic models, in order to find a representation of the patient in a feature space influenced by all data sources (visits).
Web tools such as Ingenuity Pathway Analysis will allow the integration of data at different molecular levels (genetic, protein and autoantibody), while artificial intelligence tools will allow the integration of such data, data derived from electrochemical sensors and data related to clinical and behavioural data with cognitive impairment in order to obtain a predictive model of cognitive impairment, neurodegeneration and AD.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 1,150 is above the median of 150 across 997 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Instituto de Salud Carlos III is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will be carried out on non-institutionalised subjects in the study locations, aged 55 to 70 years, attached to the PC centres of the territories included in the study, with a living history (at least one record in the last 12 months). The individuals will be selected from lists of patients from the participating practices in the 7 geographical locations, each of them providing 150 patients. The sample will be obtained by stratified by age (5-year wide strata) and sex who do not include any diagnosis of mild CD in their clinical records (MMSE= 24-27 points). Any refusal to participate after screening will be replaced by the next subject on the sampling list from the same centre and stratum. Samples will be collected at baseline and at 16 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Cognitive level
Evaluated with Minimental State Examination (min 0 - max 30, higher scores mean a better outcome) and Montreal Cognitive Assessment (min 0 - max 30, higher scores mean a better outcome)
Time frame: 16 months
multi-omics biomarkers
this will be performed with the Illumina Infinium Global Screening array, which allows direct analysis of 750,000 SNPs with a design aimed at Personalised Medicine. These data will be used to estimate the polygenic risk score for cognitive impairment, which is a single quantitative value of the genetic load for CD for each sample/individual.
Time frame: 16 months
Social support network.
The investigators will use the Arizona Social Support Interview Schedule (Barrera 1980) which elicits networks related to material help, physical assistance, intimate interaction, guidance, feedback and positive social interactions.
Time frame: 16 months
social interactions
The investigators will use several game-theoretic scenarios (prisoner's dilemma, trust game, investor game, risk aversion and dictator game, Cigarini et al 2018) to elicit how participants interact with each other when there may be different interaction outcomes depending on each other's behaviour. This, on the one hand, relates to the stability of social connections and, on the other hand, to their formation.
Time frame: 16 months
personalised behavioural patterns.
sing mobile applications that allow continuous and passive collection of a person's behavioural data such as daily patterns of steps, distance travelled, time spent using apps, sleep and presence at home. The aim will be to use such a monitoring tool in the cohort of patients under study, using artificial intelligence methods for the extraction of personalised behavioural patterns that can be combined with other sources of information.
Time frame: 16 months
Gait speed
the time it takes the person to walk a given distance, usually 4 m, expressed in metres/second.
Time frame: 16 months
The fluency and content of speech
two algorithms are proposed: a) paralinguistic system based on acoustic processing of the recordings with different versions depending on whether the audio comes from the recording of a memory test, or from a description of an image presented to the patient, b) analysis of speech content (obtained through an automatic speech recognition system) using natural language processing algorithms that extract the most relevant feature vector, as well as the calculation of statistics related to the hit/fail ratio of the memory tests.
Time frame: 16 months
Plan to share: Yes — All data files generated by the project studies, if they can be k-anonymised, may be distributed in open access, accompanied by a "Readme" file in free text format containing the metadata (title, project and funding information, contact information, date of collection, geographical contact information, date of collection, geographical information, keywords, data information, licence, associated Handles/DOIs, method of generation, method of method, method of processing and analysis, list of variables included (definition, description (definition, description, units of measurement)). The metadata contained in the Readme file shall use a standardised language, using W3C/ISO 8601 date and time formats; taxonomy and nomenclature accepted by the scientific community (CIE10, CIAP2, etc.) and including keywords with MeSH/DeCS terminology. In addition, publications and datasets that are deposited in repositories. https://zenodo.org/record/8379825
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: During 2026
Access criteria: They will be published on the Rapisalud platform (https://repisalud.isciii.es).
Data sharing details ↗ · repisalud.isciii.es
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Instituto de Salud Carlos III