Parkinson DiseasePREDICT-NEURNCT07651085
Biomarkers in Alzheimer's and Parkinson's Diseases for IA
An observational study of Parkinson Disease and Alzheimer Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
Investigate whether endogenous and exogenous risk factors, the presence of pathological amyloid aggregates and alpha-synuclein in the CSF, brain connectivity, and some clinical and biological indices such as vigilance, general motility, the sleep-wake cycle, genomic instability and possible DNA damage may correlate… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Parkinson Disease, Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Neuropsycological assesment, cerebral MRI and EEG
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 8 Feb 2024to 20 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Adult, Older adult
Study population: Parkinson's Disease with Dementia; Parkinson's Disease with Mild Cognitive Impairment; Alzheimer's Disease with Dementia; Alzheimer's Disease with Mild Cognitive Impairment; Healthy Control Group.
Who may be able to join
- The subject must be over 60 years of age;
- The Subject must have a full understanding of the Italian language;
- The subject is available to participate in the phase telemonitoring.
Who cannot join
- Inability to sign the informed consent;
- Severe dementia;
- Other concomitant diseases;
- Inability to participate in study procedures;
- Presence of arrhythmia, heart failure or previous heart attack, peripheral vascular disease or impaired circulation, valvular disease (diseases affecting the aortic valve), other diseases known conditions, end-stage renal disease (ESRD), diabetes, neurological disorders (e.g example, tremors), bleeding disorder or taking prescribed anticoagulants, tattoo(s) on the wrist where you will wear the Samsung Galaxy Watch, you will have an implanted pacemaker, a defibrillator implanted heart or other implanted electronic devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Endogenous and Exogenous Risk Factors in Patients With Alzheimer's and Parkinson's Diseases Using Clinical Indexes and Endophenotypes (Biomarkers) as Inputs to Artificial Intelligence
Investigate whether endogenous and exogenous risk factors, the presence of pathological amyloid aggregates and alpha-synuclein in the CSF, brain connectivity, and some clinical and biological indices such as vigilance, general motility, the sleep-wake cycle, genomic instability and possible DNA damage may correlate with (or predict) the clinical condition of mild cognitive impairment (MCI) and dementia in patients with Alzheimer's disease (AD) and Parkinson's disease (PD).
Read the detailed description
Study Description
Brief Summary
The study will investigate whether endogenous and exogenous risk factors, the presence of pathological amyloid aggregates and alpha-synuclein in cerebrospinal fluid (CSF), brain connectivity, and selected clinical and biological indices, including vigilance, general motility, sleep-wake cycle characteristics, genomic instability, and DNA damage, are associated with or predictive of mild cognitive impairment (MCI) and dementia in patients with Alzheimer's disease (AD) and Parkinson's disease (PD).
Detailed Description
Parkinson's disease (PD) and Alzheimer's disease (AD) are characterized by progressive neurodegeneration associated predominantly with alpha-synuclein and beta-amyloid pathology, respectively. In patients with PD, mild cognitive impairment (PD-MCI), characterized primarily by executive dysfunction, and Parkinson's disease dementia (PDD) are common and have been associated with functional abnormalities in frontal, temporal, and parietal neural networks as identified through resting-state electroencephalography (rsEEG) and magnetic resonance imaging (MRI). In patients with AD-related MCI (AD-MCI) and Alzheimer's disease dementia (ADD), these techniques have revealed predominant episodic memory deficits associated with alterations in default mode and visuospatial neural networks.
Both disorders are also associated with frequently underrecognized abnormalities in vigilance and sleep regulation. Endogenous risk factors, including genetic profile, frailty, sex, and age, as well as exogenous factors such as lifestyle, may significantly influence cognitive impairment in PD and AD. Biomarkers derived from MRI and rsEEG may reflect these effects and contribute to variability in disease progression, prevention strategies, and therapeutic interventions.
Artificial intelligence (AI) systems integrating genetic, clinical, neuropsychological, neuroimaging, and EEG data obtained in hospital settings and through home-based telemonitoring may improve the classification and prediction of clinical status in individuals with PD and AD presenting with MCI or dementia. Clinical and instrumental data will be collected both in hospital and at home during a one-week monitoring period and will be used as input for AI-based predictive models.
Hospital-based assessments will include blood sampling, neurological and neuropsychological evaluations, MRI and EEG recordings in patients with PD, AD, and healthy control participants. Additional assessments in patients with PD and AD will include cerebrospinal fluid biomarkers, dopamine transporter single-photon emission computed tomography (DAT-SPECT), and home-based telemonitoring of vigilance, cognition, heart rate, and sleep.
The expected duration of the study is approximately two years.
Specific Aim 1
The study will evaluate whether genetic, neuropathological, neuroimaging, rsEEG, and neurophysiological markers derived from standard hospital-based procedures can be used as inputs for advanced linear regression analyses and artificial intelligence models to predict vigilance, cognitive, motor, autonomic, and clinical status (MCI and dementia) in patients with AD and PD, compared with healthy control participants, with an expected classification accuracy exceeding 80%.
Specific Aim 2
The study will evaluate whether digital markers of motor function, sleep-wake cycle regulation, cognition, and overall stress derived from one week of home-based telemonitoring can provide accurate classification of patients with PD and AD according to clinical status (MCI or dementia), with an expected accuracy exceeding 70%. Furthermore, the integration of digital telemonitoring markers with hospital-derived biomarkers will be assessed to determine whether classification performance can be improved, with an expected accuracy exceeding 85%.
Specific Aim 3
The study will evaluate the mediating and moderating effects of endogenous and exogenous risk factors on the relationships between disease-specific neuropathological biomarkers (CSF biomarkers and DAT-SPECT measures), EEG and neuroimaging markers, and the severity of cognitive impairment as reflected by MCI and dementia in patients with AD and PD. Incorporation of these risk factor effects into predictive models is expected to improve patient classification according to cognitive status, with an anticipated accuracy exceeding 90%.
- Being tested
- Neuropsycological assesment, cerebral MRI, EEG, Venous blood sample of 20ml, Sample collection of exfoliated buccal mucosa
- Keywords
- Endogenous and exogeneous risk factors, Prediction of disease progression, Biomarkers, Magnetic Resonance Imaging (MRI), Quantitative Electroencephalography (qEEG), Vigilance and Sleep disorders
- Medical subject headings
- Parkinson Disease, Alzheimer Disease, Cognitive Dysfunction, Dementia, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsycological assesmentDiagnostic test
Also called (PD-CFRS) Parkinsons's Disease Cognitive Functional Rating Scale, (ADL) Activities of daily living, (IADL) Instrumental ADL, Questionario Riserva Cognitiva
Administration of Cognitive and Behavioral Tests
cerebral MRIRadiation
Also called MRI
Brain connectivity assessed through MRI biomarkers
EEGOther
Brain connectivity assessed through EEG biomarkers
Venous blood sample of 20mlBiological
Venous blood sample of 20ml
Sample collection of exfoliated buccal mucosaBiological
Sample collection of exfoliated buccal mucosa
Telemonitoring at home for 1 weekDevice
Patients are trained in the correct use of home telemonitoring devices. The staff will guide the patient in the use of the devices, training him in the autonomous management of the instruments. The devices delivered to each patient will be the Samsung Galaxy4 smartwatch, and a Samsung tablet with the serious games SMARTME\&YOU video game application installed.
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | * Neurological examination and collection of anamnestic information;
* Collection of the instrumental data;
* Neuropsychological Assesment;
* Venous blood sample of 20ml;
* Sample collection of exfoliated buccal mucosa. Receives: Diagnostic Test: Neuropsycological assesment; Radiation: cerebral MRI; Other: EEG; Biological: Venous blood sample of 20ml; Biological: Sample collection of exfoliated buccal mucosa | |
| Alzheimer MCI | * Neurological examination and collection of anamnestic information;
* Collection of the instrumental data;
* Neuropsychological Assesment;
* Sample collection of exfoliated buccal mucosa;
* Training of the correct use of home telemonitoring devices;
* Telemonitoring at home for 1 week. Receives: Diagnostic Test: Neuropsycological assesment; Radiation: cerebral MRI; Other: EEG; Biological: Venous blood sample of 20ml; Biological: Sample collection of exfoliated buccal mucosa; Device: Telemonitoring at home for 1 week | |
| Alzheimer Dementia | * Neurological examination and collection of anamnestic information;
* Collection of the instrumental data;
* Neuropsychological Assesment;
* Venous blood sample of 20ml;
* Sample collection of exfoliated buccal mucosa;
* Training of the correct use of home telemonitoring devices;
* Telemonitoring at home for 1 week. Receives: Diagnostic Test: Neuropsycological assesment; Radiation: cerebral MRI; Other: EEG; Biological: Venous blood sample of 20ml; Biological: Sample collection of exfoliated buccal mucosa; Device: Telemonitoring at home for 1 week | |
| Parkinson Disease MCI | * Neurological examination and collection of anamnestic information;
* Collection of the instrumental data;
* Neuropsychological Assesment;
* Venous blood sample of 20ml;
* Sample collection of exfoliated buccal mucosa;
* Training of the correct use of home telemonitoring devices;
* Telemonitoring at home for 1 week. Receives: Diagnostic Test: Neuropsycological assesment; Radiation: cerebral MRI; Other: EEG; Biological: Venous blood sample of 20ml; Biological: Sample collection of exfoliated buccal mucosa; Device: Telemonitoring at home for 1 week | |
| Parkinson Disease Dementia | * Neurological examination and collection of anamnestic information;
* Collection of the instrumental data;
* Neuropsychological Assesment;
* Venous blood sample of 20ml;
* Sample collection of exfoliated buccal mucosa;
* Training of the correct use of home telemonitoring devices;
* Telemonitoring at home for 1 week. Receives: Diagnostic Test: Neuropsycological assesment; Radiation: cerebral MRI; Other: EEG; Biological: Venous blood sample of 20ml; Biological: Sample collection of exfoliated buccal mucosa; Device: Telemonitoring at home for 1 week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictivity in changes of RMN parameters
Changes in MRI-derived measures assess brain structural integrity, including white matter damage and the preservation of cortical networks. In detail, the following parameters will be measured:
White matter lesions MRI cortical network volumes Default Mode Network (DMN) Dorsal Attention Network (DAN)
Measured: At patient's enrollment (Baseline)
Predictivity of EEG
Predictivity of changes in spectral power, measured using rsEEG sources, in detail:
Power spectral density Delta band Theta band Alpha 1 band Alpha 2 band Beta 1 band Beta 2 band Gamma band
Measured: At patient's enrollment (baseline)
Predictivity of CFS and Blood derived Biomarkers
Measurement of Biomarkers in CFS and Blood samples. In particular, from CSF we will evaluate the following biomarkers:
t-tau p-tau Aβ (Amyloid-beta)
in blood samples we will evaluate: N-oxoaspartic acid N-acetylspermidine Methylselenopyruvate N-methylethanolamine phosphate Succinylacetone Capryloylglycine Acetylhistamine Androsterone Glutaric acid Cadaverine Quinolinic acid Maleylacetic acid N-methyladenosine D-erythrose L-cysteine Dethiobiotin Tetradecenoylcarnitine Beta-hydroxybutyric acid L-pyroglutamic acid Creatine Uric acid Propionylcarnitine Ophthalmic acid Homovanillic acid L-histidine L-serine phosphate Nicotinuric acid Diaminoadenosine L-methionine L-asparagine
Measured: At patient's enrollment (Baseline)
Predictivity of clinical parameters
The following clinical assessment tools will be used:
Clinical assessment scales MDS-UPDRS Part III Beck Depression Inventory-II (BDI-II) Mini-Mental State Examination (MMSE) Montreal Cognitive Assessment (MoCA) Rey Auditory Verbal Learning Test - Immediate Recall (RAVLT Immediate) Rey Auditory Verbal Learning Test - Delayed Recall (RAVLT Delayed) Clock Drawing Test Semantic Fluency Test Phonemic Fluency Test
Clinical and lifestyle variables Heart rate Physical activity Smoking status Hypertension Comorbidities (any additional disease) Body Mass Index (BMI)
Measured: At patient's enrollment (Baseline)
Predictivity of digital telemonitoring
By using electronic devices such as tablets and smartwatch we will assess parameters of cognitive function and quality of sleep. In details, by using specifically designed video games we will measured reaction time and accuracy of reaction. Quality of sleep will be recorded by wearing a smartwatch that will measure sleep duration, efficiency and quality.
Interactive serious videogame response assessment Accuracy Reaction time
Watch-derived measures Sleep duration Sleep efficiency Sleep quality
Steps per day Intentional steps Incidental steps Average cadence during the best 30 minutes of the day
Measured: From enrollment to the end of telemonitoring at day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start8 Feb 2024
- Primary completion19 May 2026
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza, Azienda Ospedaliera di Padova, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651085
- Sponsor's protocol ID
- RP 22/26
- Acronym
- PREDICT-NEUR
- Status last verified
- Jun 2026
- First submitted
- 29 Jul 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Endogenous and Exogenous Risk Factors in Patients With Alzheimer's and Parkinson's Diseases Using Clinical Indexes and Endophenotypes (Biomarkers) as Inputs to Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07651085
- Acronym / sponsor ID
- PREDICT-NEUR / RP 22/26
- Keywords
- Endogenous and exogeneous risk factors, Prediction of disease progression, Biomarkers, Magnetic Resonance Imaging (MRI), Quantitative Electroencephalography (qEEG), Vigilance and Sleep disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza, Azienda Ospedaliera di Padova, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 16 Jun 2026 (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.
Investigate whether endogenous and exogenous risk factors, the presence of pathological amyloid aggregates and alpha-synuclein in the CSF, brain connectivity, and some clinical and biological indices such as vigilance, general motility, the sleep-wake cycle, genomic instability and possible DNA damage may correlate with (or predict) the clinical condition of mild cognitive impairment (MCI) and dementia in patients with Alzheimer's disease (AD) and Parkinson's disease (PD).
Detailed description
Study Description
Brief Summary
The study will investigate whether endogenous and exogenous risk factors, the presence of pathological amyloid aggregates and alpha-synuclein in cerebrospinal fluid (CSF), brain connectivity, and selected clinical and biological indices, including vigilance, general motility, sleep-wake cycle characteristics, genomic instability, and DNA damage, are associated with or predictive of mild cognitive impairment (MCI) and dementia in patients with Alzheimer's disease (AD) and Parkinson's disease (PD).
Detailed Description
Parkinson's disease (PD) and Alzheimer's disease (AD) are characterized by progressive neurodegeneration associated predominantly with alpha-synuclein and beta-amyloid pathology, respectively. In patients with PD, mild cognitive impairment (PD-MCI), characterized primarily by executive dysfunction, and Parkinson's disease dementia (PDD) are common and have been associated with functional abnormalities in frontal, temporal, and parietal neural networks as identified through resting-state electroencephalography (rsEEG) and magnetic resonance imaging (MRI). In patients with AD-related MCI (AD-MCI) and Alzheimer's disease dementia (ADD), these techniques have revealed predominant episodic memory deficits associated with alterations in default mode and visuospatial neural networks.
Both disorders are also associated with frequently underrecognized abnormalities in vigilance and sleep regulation. Endogenous risk factors, including genetic profile, frailty, sex, and age, as well as exogenous factors such as lifestyle, may significantly influence cognitive impairment in PD and AD. Biomarkers derived from MRI and rsEEG may reflect these effects and contribute to variability in disease progression, prevention strategies, and therapeutic interventions.
Artificial intelligence (AI) systems integrating genetic, clinical, neuropsychological, neuroimaging, and EEG data obtained in hospital settings and through home-based telemonitoring may improve the classification and prediction of clinical status in individuals with PD and AD presenting with MCI or dementia. Clinical and instrumental data will be collected both in hospital and at home during a one-week monitoring period and will be used as input for AI-based predictive models.
Hospital-based assessments will include blood sampling, neurological and neuropsychological evaluations, MRI and EEG recordings in patients with PD, AD, and healthy control participants. Additional assessments in patients with PD and AD will include cerebrospinal fluid biomarkers, dopamine transporter single-photon emission computed tomography (DAT-SPECT), and home-based telemonitoring of vigilance, cognition, heart rate, and sleep.
The expected duration of the study is approximately two years.
Specific Aim 1
The study will evaluate whether genetic, neuropathological, neuroimaging, rsEEG, and neurophysiological markers derived from standard hospital-based procedures can be used as inputs for advanced linear regression analyses and artificial intelligence models to predict vigilance, cognitive, motor, autonomic, and clinical status (MCI and dementia) in patients with AD and PD, compared with healthy control participants, with an expected classification accuracy exceeding 80%.
Specific Aim 2
The study will evaluate whether digital markers of motor function, sleep-wake cycle regulation, cognition, and overall stress derived from one week of home-based telemonitoring can provide accurate classification of patients with PD and AD according to clinical status (MCI or dementia), with an expected accuracy exceeding 70%. Furthermore, the integration of digital telemonitoring markers with hospital-derived biomarkers will be assessed to determine whether classification performance can be improved, with an expected accuracy exceeding 85%.
Specific Aim 3
The study will evaluate the mediating and moderating effects of endogenous and exogenous risk factors on the relationships between disease-specific neuropathological biomarkers (CSF biomarkers and DAT-SPECT measures), EEG and neuroimaging markers, and the severity of cognitive impairment as reflected by MCI and dementia in patients with AD and PD. Incorporation of these risk factor effects into predictive models is expected to improve patient classification according to cognitive status, with an anticipated accuracy exceeding 90%.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | – | Diagnostic Test: Neuropsycological assesment, Radiation: cerebral MRI, Other: EEG, Biological: Venous blood sample of 20ml, Biological: Sample collection of exfoliated buccal mucosa* Neurological examination and collection of anamnestic information; * Collection of the instrumental data; * Neuropsychological Assesment; * Venous blood sample of 20ml; * Sample collection of exfoliated buccal mucosa. |
| Alzheimer MCI | – | Diagnostic Test: Neuropsycological assesment, Radiation: cerebral MRI, Other: EEG, Biological: Venous blood sample of 20ml, Biological: Sample collection of exfoliated buccal mucosa, Device: Telemonitoring at home for 1 week* Neurological examination and collection of anamnestic information; * Collection of the instrumental data; * Neuropsychological Assesment; * Sample collection of exfoliated buccal mucosa; * Training of the correct use of home telemonitoring devices; * Telemonitoring at home for 1 week. |
| Alzheimer Dementia | – | Diagnostic Test: Neuropsycological assesment, Radiation: cerebral MRI, Other: EEG, Biological: Venous blood sample of 20ml, Biological: Sample collection of exfoliated buccal mucosa, Device: Telemonitoring at home for 1 week* Neurological examination and collection of anamnestic information; * Collection of the instrumental data; * Neuropsychological Assesment; * Venous blood sample of 20ml; * Sample collection of exfoliated buccal mucosa; * Training of the correct use of home telemonitoring devices; * Telemonitoring at home for 1 week. |
| Parkinson Disease MCI | – | Diagnostic Test: Neuropsycological assesment, Radiation: cerebral MRI, Other: EEG, Biological: Venous blood sample of 20ml, Biological: Sample collection of exfoliated buccal mucosa, Device: Telemonitoring at home for 1 week* Neurological examination and collection of anamnestic information; * Collection of the instrumental data; * Neuropsychological Assesment; * Venous blood sample of 20ml; * Sample collection of exfoliated buccal mucosa; * Training of the correct use of home telemonitoring devices; * Telemonitoring at home for 1 week. |
| Parkinson Disease Dementia | – | Diagnostic Test: Neuropsycological assesment, Radiation: cerebral MRI, Other: EEG, Biological: Venous blood sample of 20ml, Biological: Sample collection of exfoliated buccal mucosa, Device: Telemonitoring at home for 1 week* Neurological examination and collection of anamnestic information; * Collection of the instrumental data; * Neuropsychological Assesment; * Venous blood sample of 20ml; * Sample collection of exfoliated buccal mucosa; * Training of the correct use of home telemonitoring devices; * Telemonitoring at home for 1 week. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Parkinson's Disease with Dementia; Parkinson's Disease with Mild Cognitive Impairment; Alzheimer's Disease with Dementia; Alzheimer's Disease with Mild Cognitive Impairment; Healthy Control Group.
Key inclusion criteria (3 listed)
- The subject must be over 60 years of age;
- The Subject must have a full understanding of the Italian language;
- The subject is available to participate in the phase telemonitoring.
Key exclusion criteria (5 listed)
- Inability to sign the informed consent;
- Severe dementia;
- Other concomitant diseases;
- Inability to participate in study procedures;
- Presence of arrhythmia, heart failure or previous heart attack, peripheral vascular disease or impaired circulation, valvular disease (diseases affecting the aortic valve), other diseases known conditions, end-stage renal disease (ESRD), diabetes, neurological disorders (e.g example, tremors), bleeding disorder or taking prescribed anticoagulants, tattoo(s) on the wrist where you will wear the Samsung Galaxy Watch, you will have an implanted pacemaker, a defibrillator implanted heart or other implanted electronic devices.
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 |
|---|---|---|
| Neuropsycological assesmentAlso: (PD-CFRS) Parkinsons's Disease Cognitive Functional Rating Scale, (ADL) Activities of daily living, (IADL) Instrumental ADL, Questionario Riserva CognitivaAdministration of Cognitive and Behavioral Tests | Diagnostic test | Alzheimer Dementia, Alzheimer MCI, Parkinson Disease Dementia, Parkinson Disease MCI, healthy subjects |
| cerebral MRIAlso: MRIBrain connectivity assessed through MRI biomarkers | Radiation | Alzheimer Dementia, Alzheimer MCI, Parkinson Disease Dementia, Parkinson Disease MCI, healthy subjects |
| EEGBrain connectivity assessed through EEG biomarkers | Other | Alzheimer Dementia, Alzheimer MCI, Parkinson Disease Dementia, Parkinson Disease MCI, healthy subjects |
| Venous blood sample of 20mlVenous blood sample of 20ml | Biological | Alzheimer Dementia, Alzheimer MCI, Parkinson Disease Dementia, Parkinson Disease MCI, healthy subjects |
| Sample collection of exfoliated buccal mucosaSample collection of exfoliated buccal mucosa | Biological | Alzheimer Dementia, Alzheimer MCI, Parkinson Disease Dementia, Parkinson Disease MCI, healthy subjects |
| Telemonitoring at home for 1 weekPatients are trained in the correct use of home telemonitoring devices. The staff will guide the patient in the use of the devices, training him in the autonomous management of the instruments. The devices delivered to each patient will be the Samsung Galaxy4 smartwatch, and a Samsung tablet with the serious games SMARTME\&YOU video game application installed. | Device | Alzheimer Dementia, Alzheimer MCI, Parkinson Disease Dementia, Parkinson Disease MCI |
Primary outcome
Predictivity in changes of RMN parameters
Time frame: At patient's enrollment (Baseline)
Changes in MRI-derived measures assess brain structural integrity, including white matter damage and the preservation of cortical networks. In detail, the following parameters will be measured: White matter lesions MRI cortical network volumes Default Mode Network (DMN) Dorsal Attention Network (DAN)
Predictivity of EEG
Time frame: At patient's enrollment (baseline)
Predictivity of changes in spectral power, measured using rsEEG sources, in detail: Power spectral density Delta band Theta band Alpha 1 band Alpha 2 band Beta 1 band Beta 2 band Gamma band
Predictivity of CFS and Blood derived Biomarkers
Time frame: At patient's enrollment (Baseline)
Measurement of Biomarkers in CFS and Blood samples. In particular, from CSF we will evaluate the following biomarkers: t-tau p-tau Aβ (Amyloid-beta) in blood samples we will evaluate: N-oxoaspartic acid N-acetylspermidine Methylselenopyruvate N-methylethanolamine phosphate Succinylacetone Capryloylglycine Acetylhistamine Androsterone Glutaric acid Cadaverine Quinolinic acid Maleylacetic acid N-methyladenosine D-erythrose L-cysteine Dethiobiotin Tetradecenoylcarnitine Beta-hydroxybutyric acid L-pyroglutamic acid Creatine Uric acid Propionylcarnitine Ophthalmic acid Homovanillic acid L-histidine L-serine phosphate Nicotinuric acid Diaminoadenosine L-methionine L-asparagine
Predictivity of clinical parameters
Time frame: At patient's enrollment (Baseline)
The following clinical assessment tools will be used: Clinical assessment scales MDS-UPDRS Part III Beck Depression Inventory-II (BDI-II) Mini-Mental State Examination (MMSE) Montreal Cognitive Assessment (MoCA) Rey Auditory Verbal Learning Test - Immediate Recall (RAVLT Immediate) Rey Auditory Verbal Learning Test - Delayed Recall (RAVLT Delayed) Clock Drawing Test Semantic Fluency Test Phonemic Fluency Test Clinical and lifestyle variables Heart rate Physical activity Smoking status Hypertension Comorbidities (any additional disease) Body Mass Index (BMI)
Predictivity of digital telemonitoring
Time frame: From enrollment to the end of telemonitoring at day 7
By using electronic devices such as tablets and smartwatch we will assess parameters of cognitive function and quality of sleep. In details, by using specifically designed video games we will measured reaction time and accuracy of reaction. Quality of sleep will be recorded by wearing a smartwatch that will measure sleep duration, efficiency and quality. Interactive serious videogame response assessment Accuracy Reaction time Watch-derived measures Sleep duration Sleep efficiency Sleep quality Steps per day Intentional steps Incidental steps Average cadence during the best 30 minutes of the day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Parkinson Disease and Alzheimer Disease, run by IRCCS San Raffaele Roma 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 3 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: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictivity in changes of RMN parameters (time frame: At patient's enrollment (Baseline)). The study lists 5 primary outcomes in all. 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 16 Jun 2026.