Cognitive DysfunctionDENDRITENCT06114290
Personalised Medicine in the Identification of Preclinical Cognitive Impairment. Development of a Predictive Risk Model
An observational study of Cognitive Dysfunction, run by Instituto de Salud Carlos III at 8 sites in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Cognitive Dysfunction
- How many people
- 1,150 participants
- Where
- 8 sitesSpain
- Study dates
- 1 Nov 2023to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites, 8 recruiting
- Recruiting
Zone 8 Health Center
Albacete, Castille-La Mancha, 02006
María Emilia Villena
- Recruiting
Irala Health Center
Bilbao, 48012
Mª Ángeles Cidoncha
Verónica Tiscar
- Recruiting
Gibraleón Health Center
Gibraleón, Huelva, 21500
Rafaela Camacho
- Recruiting
Onze de Setembre Health Center
Lleida, 25005
Esther Rubinat
- Recruiting
San Andres Health Centre
Madrid
Pedro Otones
- Recruiting
Punta Umbría Health Center
Punta Umbría, Huelva, 21100
Rafaela Camacho
- Recruiting
Sant Vicent I Health Center
San Vicent del Raspeig, Alicante, 03690
María Isabel Orts
- Recruiting
Camps Blanc Health Center
Sant Boi de Llobregat, Barcelona, 08830
Mª Isabel Feria
About this study
Official title: Personalised Medicine in the Early Identification of Preclinical Cognitive Impairment. Development of a Predictive Risk Model.
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.
Read the detailed description
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.
- Conditions
- Cognitive Dysfunction
- Keywords
- Cognitive Dysfunction, Early Diagnosis, Primary Health Care, Biomarkers, Artificial Intelligence, Precision Medicine, Care
- Medical subject headings
- Cognitive Dysfunction, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 16 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 months
Gait speed
the time it takes the person to walk a given distance, usually 4 m, expressed in metres/second.
Measured: 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.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Nov 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Salud Carlos III
- Sponsor type
- Other government
- Collaborators
- Instituto de Investigación Biomédica de Salamanca, Carlos III Health Institute, Universidad Complutense de Madrid, Biomedical Research Networking Centre on Frailty and Healthy Ageing, Biomedical Research Networking Centre on Mental Health, Institute of Biomedical Research of Lleida, Institute of Health and Biomedical Research of Alicante, Universidad Carlos III de Madrid, University of Vigo, Foundation for Biosanitary Research and Innovation in Primary Health Care, Biomedical Research Networking Centre on Epidemiology and Public Health, Research Network on Chronicity, Primary Care and Health Prevention and Promotion
- Responsible party
- Principal investigator, Teresa Moreno Casbas, Instituto de Salud Carlos III
- Investigators
- Angeles Almeida, PhD, Principal investigator, Consejo Superior de Investigaciones Científicas (CSIC)Rodrigo Barderas, PhD, Principal investigator, Instituto de Salud Carlos IIIMARIA TERESA MORENO-CASBAS, PhD, Principal investigator, Nursing and Healthcare Research Unit (Investén-isciii). Instituto de Salud Carlos III. Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114290
- Sponsor's protocol ID
- PMP22/00084
- Acronym
- DENDRITE
- Status last verified
- Jan 2024
- First submitted
- 11 Oct 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Medicine in the Early Identification of Preclinical Cognitive Impairment. Development of a Predictive Risk Model.
- ClinicalTrials.gov ID
- NCT06114290
- Acronym / sponsor ID
- DENDRITE / PMP22/00084
- Conditions
- Cognitive Dysfunction
- Keywords
- Cognitive Dysfunction, Early Diagnosis, Primary Health Care, Biomarkers, Artificial Intelligence, Precision Medicine, Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- Instituto de Salud Carlos IIIOther government
- Collaborators
- Instituto de Investigación Biomédica de Salamanca, Carlos III Health Institute, Universidad Complutense de Madrid, Biomedical Research Networking Centre on Frailty and Healthy Ageing, Biomedical Research Networking Centre on Mental Health, Institute of Biomedical Research of Lleida, Institute of Health and Biomedical Research of Alicante, Universidad Carlos III de Madrid, University of Vigo, Foundation for Biosanitary Research and Innovation in Primary Health Care, Biomedical Research Networking Centre on Epidemiology and Public Health, Research Network on Chronicity, Primary Care and Health Prevention and Promotion
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive level
Time frame: 16 months
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)
6 secondary outcomes
multi-omics biomarkers
Time frame: 16 months
Social support network.
Time frame: 16 months
social interactions
Time frame: 16 months
personalised behavioural patterns.
Time frame: 16 months
Gait speed
Time frame: 16 months
The fluency and content of speech
Time frame: 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angeles Almeida, PhD principal investigator
Consejo Superior de Investigaciones Científicas (CSIC)
Rodrigo Barderas, PhD principal investigator
Instituto de Salud Carlos III
MARIA TERESA MORENO-CASBAS, PhD principal investigator
Nursing and Healthcare Research Unit (Investén-isciii). Instituto de Salud Carlos III. Madrid
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction, run by Instituto de Salud Carlos III at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mayte Moreno-Casbas (+34 637390052, mmoreno@isciii.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive level (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.