Cognitive Dysfunction Clinical Trial
— DENDRITEOfficial title:
Personalised Medicine in the Early Identification of Preclinical Cognitive Impairment. Development of a Predictive Risk Model.
NCT number | NCT06114290 |
Other study ID # | PMP22/00084 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2023 |
Est. completion date | July 2025 |
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.
Status | Recruiting |
Enrollment | 1150 |
Est. completion date | July 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 70 Years |
Eligibility | Inclusion Criteria: - Non-institutionalised subjects from the study locations. - Aged between 55 and 70 years, attached to the PC centres of the territories included in the study - Living history (at least one record in the last 12 months) - Without an established diagnosis of CI. Exclusion Criteria: - Participants with significant difficulties in completing self-reported questionnaires - Those in whom genetic or biological testing may be affected by an underlying genetic or health condition. - Underlying genetic or health condition. - Patients who are hospitalised or institutionalised during follow-up will be excluded. |
Country | Name | City | State |
---|---|---|---|
Spain | Zone 8 Health Center | Albacete | Castilla-La Mancha |
Spain | Irala Health Center | Bilbao | |
Spain | Gibraleón Health Center | Gibraleón | Huelva |
Spain | Onze de Setembre Health Center | Lleida | |
Spain | San Andres Health Centre | Madrid | |
Spain | Punta Umbría Health Center | Punta Umbría | Huelva |
Spain | Sant Vicent I Health Center | San Vicente Del Raspeig | Alicante |
Spain | Camps Blanc Health Center | Sant Boi De Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Instituto de Salud Carlos III | Biomedical Research Networking Centre on Epidemiology and Public Health, Biomedical Research Networking Centre on Frailty and Healthy Ageing, Biomedical Research Networking Centre on Mental Health, Carlos III Health Institute, Carlos III University of Madrid, Foundation for Biosanitary Research and Innovation in Primary Health Care, Institute of Biomedical Research of Lleida, Institute of Health and Biomedical Research of Alicante, Instituto de Investigación Biomédica de Salamanca, Research Network on Chronicity, Primary Care and Health Prevention and Promotion, Universidad Complutense de Madrid, University of Vigo |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 16 months | |
Secondary | 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. | 16 months | |
Secondary | 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. | 16 months | |
Secondary | 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. | 16 months | |
Secondary | 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. | 16 months | |
Secondary | Gait speed | the time it takes the person to walk a given distance, usually 4 m, expressed in metres/second. | 16 months | |
Secondary | 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. | 16 months |
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