DementiaPRECUBE2022NCT06227364
Prediction, Prevention, Predisposition: Applications in Neurology and Endocrinology
An observational study of Dementia and Mild Cognitive Impairment, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
This project aims to introduce solutions for strengthening the management capabilities of two types of patients, in terms of care and prevention. Specifically, it is aimed at neurological patients with mild or minor neurocognitive decline (Mild Cognitive Impairment, MCI) and endocrinological patients diagnosed with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dementia, Mild Cognitive Impairment
- What is being tested?
- MCI patients and metabolic patients
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 8 Mar 2023to 21 Jan 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: N 100 patients diagnosed with MCI and N 100 patients with BMI > 30 kg/m² with or without comorbidities, coming from the external basin, family doctors or other specialists, will be recruited at the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino Pulejo of Messina.
Who may be able to join
- For MCI patients:
- Patients aged between 18 and 80 years; Clinical and instrumental diagnosis of MCI, according to the normal clinical practice adopted; Written informed consent obtained from the patient;
- For Metabolic patients:
- Age: >18 years BMI > 30 kg/m²
- Willingness to follow requests as per protocol, including:
- Signing an informed consent. Participation in scheduled follow-up visits. Carrying out instrumental and laboratory tests
Who cannot join
- For MCI patients:
- age under 40 other concomitant neurological and/or psychiatric condition drug abuse unstable clinical conditions requiring acute hospitalization.
- For Metabolic patients:
- unstable clinical conditions requiring acute hospitalization. associated serious pathologies and/or with reduced life expectancy, including renal failure under dialysis treatment, liver cirrhosis, malignant neoplasms, NYHA class III-IV heart failure, chronic respiratory failure under oxygen therapy.
- psychological or psychiatric conditions that may reduce study cooperation.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Irccs Centro Neurolesi Bonino Pulejo
Messina, 98124
silvia marino, dr, +3909060128110, silvia.marino@irccsme.it
About this study
Official title: PRE3 PRE-CUBE. PREdiction, PREvention, PREdisposition: Applications in Neurology and Endocrinology
This project aims to introduce solutions for strengthening the management capabilities of two types of patients, in terms of care and prevention. Specifically, it is aimed at neurological patients with mild or minor neurocognitive decline (Mild Cognitive Impairment, MCI) and endocrinological patients diagnosed with obesity. The study want to enhance the predictive capacity of the care process management system through an Artificial Intelligence (AI) system. All patients diagnosed with MCI and obesity who, within 30 months, will be referred to the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina will be evaluated.
Study design
Read more
Patients will not be subjected to any procedure that goes beyond normal clinical practice; the clinical and neuropsychological variables that will be collected for the study are those that are commonly collected in normal clinical practice. All patients diagnosed with MCI and obesity who, within 30 months, will be referred to the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina will be evaluated.
All patients will undergo clinical, neuropsychological and psychological evaluation at the beginning (baseline T0), at the end (T1) and after ... months from the end of treatment (follow up T2).
Read the detailed description
This project aims to introduce solutions for strengthening the management capabilities of two types of patients, in terms of care and prevention. Specifically, it is aimed at neurological patients with mild or minor neurocognitive decline (Mild Cognitive Impairment, MCI) and endocrinological patients diagnosed with obesity. The study want to enhance the predictive capacity of the care process management system through an Artificial Intelligence (AI) system. All patients diagnosed with MCI and obesity who, within 30 months, will be referred to the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina will be evaluated.
Study design
Patients will not be subjected to any procedure that goes beyond normal clinical practice; the clinical and neuropsychological variables that will be collected for the study are those that are commonly collected in normal clinical practice. All patients diagnosed with MCI and obesity who, within 30 months, will be referred to the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina will be evaluated.
All patients will undergo clinical, neuropsychological and psychological evaluation at the beginning (baseline T0), at the end (T1) and after ... months from the end of treatment (follow up T2).
- Conditions
- Dementia, Mild Cognitive Impairment
- Being tested
- MCI patients, metabolic patients
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCI patientsDiagnostic test
patients with mild cognitive impairment submitted to Magnetic Resonance, neuropsychological evaluation, neurological assessment
metabolic patientsDiagnostic test
patients with obesity and metabolic dysfunction submitted to haematological tests, psychological and neuropsychological evaluation and endocrinologu assessment
| Study group | Role | What they receive |
|---|---|---|
| MCI patients | patients with mild cognitive impairment submitted to Magnetic Resonance, neuropsychological evaluation, neurological assessment Receives: Diagnostic Test: MCI patients | |
| Metabolic patients | patietns with obesity and metabollic dysfunction submitted to haematological tests, psychological and neuropsychological evaluations and endocrinology assessment Receives: Diagnostic Test: metabolic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
the creation of predictive algorithms capable of calculating the risk of onset and/or staging of neurodegenerative and metabolic pathologies
The project has as its primary objective the creation of predictive algorithms capable of calculating the risk of onset and/or staging of neurodegenerative and metabolic pathologies, with the aim of identifying potential targets of subjects at risk of developing such diseases, in the context of patient enrollment, as per normal clinical practice, on an outpatient basis, at our IRCCS.
Measured: 1 hour
Secondary outcomes (1)
Evaluate the effectiveness of the therapeutic path and define the outcomes of the treatment plan for these types of patients
Consider the macro-tasks relating to Taking Charge, Activation of the therapeutic, care and rehabilitation plan as well as the activation of care and follow-up services. With these macro-tasks, through an analysis of the data, it will be possible to carry out an evaluation of the effectiveness of the treatment path envisaged for the patient, identify the treatment process that follows the adopted PDTA (taking charge, evaluation, monitoring and follow-up up) and define the outcomes of the treatment plan for these types of patients, promoting a correct diagnostic classification and an effective therapeutic intervention aimed at managing comorbidities and improving the patients' quality of life.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start8 Mar 2023
- Primary completion30 Jun 2023
- Study completion21 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227364
- Sponsor's protocol ID
- PRECUBE2022
- Acronym
- PRECUBE2022
- Status last verified
- Jul 2023
- First submitted
- 9 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRE3 PRE-CUBE. PREdiction, PREvention, PREdisposition: Applications in Neurology and Endocrinology
- ClinicalTrials.gov ID
- NCT06227364
- Acronym / sponsor ID
- PRECUBE2022 / PRECUBE2022
- Conditions
- Dementia, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 21 Jan 2025 (estimated)
- First posted
- 26 Jan 2024 (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.
This project aims to introduce solutions for strengthening the management capabilities of two types of patients, in terms of care and prevention. Specifically, it is aimed at neurological patients with mild or minor neurocognitive decline (Mild Cognitive Impairment, MCI) and endocrinological patients diagnosed with obesity. The study want to enhance the predictive capacity of the care process management system through an Artificial Intelligence (AI) system. All patients diagnosed with MCI and obesity who, within 30 months, will be referred to the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina will be evaluated.
Study design
Patients will not be subjected to any procedure that goes beyond normal clinical practice; the clinical and neuropsychological variables that will be collected for the study are those that are commonly collected in normal clinical practice. All patients diagnosed with MCI and obesity who, within 30 months, will be referred to the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina will be evaluated.
All patients will undergo clinical, neuropsychological and psychological evaluation at the beginning (baseline T0), at the end (T1) and after ... months from the end of treatment (follow up T2).
Detailed description
This project aims to introduce solutions for strengthening the management capabilities of two types of patients, in terms of care and prevention. Specifically, it is aimed at neurological patients with mild or minor neurocognitive decline (Mild Cognitive Impairment, MCI) and endocrinological patients diagnosed with obesity. The study want to enhance the predictive capacity of the care process management system through an Artificial Intelligence (AI) system. All patients diagnosed with MCI and obesity who, within 30 months, will be referred to the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina will be evaluated.
Study design
Patients will not be subjected to any procedure that goes beyond normal clinical practice; the clinical and neuropsychological variables that will be collected for the study are those that are commonly collected in normal clinical practice. All patients diagnosed with MCI and obesity who, within 30 months, will be referred to the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina will be evaluated.
All patients will undergo clinical, neuropsychological and psychological evaluation at the beginning (baseline T0), at the end (T1) and after ... months from the end of treatment (follow up T2).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI patients | – | Diagnostic Test: MCI patientspatients with mild cognitive impairment submitted to Magnetic Resonance, neuropsychological evaluation, neurological assessment |
| Metabolic patients | – | Diagnostic Test: metabolic patientspatietns with obesity and metabollic dysfunction submitted to haematological tests, psychological and neuropsychological evaluations and endocrinology assessment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- N 100 patients diagnosed with MCI and N 100 patients with BMI > 30 kg/m² with or without comorbidities, coming from the external basin, family doctors or other specialists, will be recruited at the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino Pulejo of Messina.
Key inclusion criteria (6 listed)
- Patients aged between 18 and 80 years; Clinical and instrumental diagnosis of MCI, according to the normal clinical practice adopted; Written informed consent obtained from the patient;
- Age: >18 years BMI > 30 kg/m²
- Signing an informed consent. Participation in scheduled follow-up visits. Carrying out instrumental and laboratory tests
Key exclusion criteria (5 listed)
- age under 40 other concomitant neurological and/or psychiatric condition drug abuse unstable clinical conditions requiring acute hospitalization.
- unstable clinical conditions requiring acute hospitalization. associated serious pathologies and/or with reduced life expectancy, including renal failure under dialysis treatment, liver cirrhosis, malignant neoplasms, NYHA class III-IV heart failure, chronic respiratory failure under oxygen therapy.
- psychological or psychiatric conditions that may reduce study cooperation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCI patientspatients with mild cognitive impairment submitted to Magnetic Resonance, neuropsychological evaluation, neurological assessment | Diagnostic test | MCI patients |
| metabolic patientspatients with obesity and metabolic dysfunction submitted to haematological tests, psychological and neuropsychological evaluation and endocrinologu assessment | Diagnostic test | Metabolic patients |
Primary outcome
the creation of predictive algorithms capable of calculating the risk of onset and/or staging of neurodegenerative and metabolic pathologies
Time frame: 1 hour
The project has as its primary objective the creation of predictive algorithms capable of calculating the risk of onset and/or staging of neurodegenerative and metabolic pathologies, with the aim of identifying potential targets of subjects at risk of developing such diseases, in the context of patient enrollment, as per normal clinical practice, on an outpatient basis, at our IRCCS.
1 secondary outcome
Evaluate the effectiveness of the therapeutic path and define the outcomes of the treatment plan for these types of patients
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Mild Cognitive Impairment, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
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 6 inclusion and 5 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 26 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 1 site in Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the creation of predictive algorithms capable of calculating the risk of onset and/or staging of neurodegenerative and metabolic pathologies (time frame: 1 hour). 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 26 Jan 2024.