Cognitive DeclinePREVIEWNCT05569083
PRedicting the EVolution of SubjectIvE Cognitive Decline to Alzheimer's Disease With Machine Learning
An observational study of Cognitive Decline and Mild Cognitive Impairment, run by Azienda Ospedaliero-Universitaria Careggi at 4 sites in Italy.
Trial summary
Alzheimer's disease (AD) has a presymptomatic course which can last from several years to decades. Identification of subjects at an early stage is crucial for therapeutic intervention and possible prevention of cognitive decline. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Genetic analysis of APOE and BDNF genes., EEG recording and CSF collection and AD biomarker measurement
- How many people
- 350 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Oct 2020to 30 Mar 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The investigators will include in the study, consecutive spontaneous subjects who self-referred to the Centre for Alzheimer's Disease and Adult Cognitive Disorders of Careggi Hospital in Florence. The investigators will include in the study 300 patients with SCD already selected and evaluated one time (baseline) or more (follow-up) in our clinic, and they will increase the baseline sample by adding new subjects with SCD or MCI.
Who may be able to join
- Complaining of cognitive decline with a duration of ≥ 6 months;
- Normal functioning on the Activities of Daily Living and the Instrumental Activities of Daily Living scales (Lawton and Brody, 1969);
- Unsatisfied criteria for dementia at baseline (DSM-V, American Psychiatric Association, 2013).
Who cannot join
- History of head injury, current neurological and/or systemic disease, symptoms of psychosis, major depression, alcoholism or other substance abuse
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Recruiting
AOU Careggi
Florence, Tuscany, 50134
Valentina Bessi, MD, PhD, +393496096308, valentina.bessi@unifi.it
Salvatore Mazzeo, MD, +393477219137, salvatore.mazzeo@unifi.it
- Recruiting
IRCCS Don Gnocchi
Florence, 50143
Antonello Grippo, MD, PhD
Sandro Sorbi, MD, PhD
- Recruiting
Department of Neuroscience, Psychology, Drug Research and Child Health, University of Florence
Florence
Benedetta Nacmias, PhD, 055/7948910, nacmias@unifi.it
Benedetta Nacmias, PhD
- Recruiting
Istituto di Biorobotica e Dipartimento di Eccellenza in Robotica e AI, Scuola Superiore Sant'Anna
Pisa
Alberto Mazzoni, PhD
Alberto Mazzoni
About this study
Alzheimer's disease (AD) has a presymptomatic course which can last from several years to decades. Identification of subjects at an early stage is crucial for therapeutic intervention and possible prevention of cognitive decline. Current research is focused on identifying characteristics of the early stages of AD and several concepts have been developed to that end.
Subjective cognitive decline (SCD) is defined as a self-experienced persistent decline in cognitive capacity in comparison with the subject's previously normal status, during which the subject has normal age-, gender-, and education-adjusted performance on standardized cognitive tests. SCD is not related to current cognitive impairment, however it has been considered for its potential role as risk factors for AD.
The aim of this study is to evaluate, through machine learning tools, the accuracy data, neuropsychological assessment, personality traits, cognitive reserve, genetic factors, cerebrospinal fluid (CSF) neurodegeneration biomarkers, EEG and Event Related Potential recordings in predicting conversion from SCD condition, to Mild Cognitive Impairment (MCI) and AD.
Read the detailed description
The Regional Reference Center for Alzheimer's Disease and Cognitive Disorders of Careggi Hospital, Florence, started about 25 years ago to collect clinical, neuropsychological, personality and lifestyles data for patients with of Subjective Cognitive Decline (SCD). Starting from these data the aim of the present study is to increase the number of variables collected on SCD subjects and expand the clinical follow-up to delineate more accurate pathway of disease and to identify very early subject at risk of conversion in Alzheimer's Disease (AD).
The advantages of detection of cognitive impairment at the early stages are critical. Such detection has traditionally been performed manually by one or more clinicians based on reports and test results. Machine learning algorithms offer a method of detection that may provide an automated process and valuable insights into diagnosis and classification. With this tool clinicians could design optimal screenings to predict, already at the stage of SCD, possible evolutions of the patient's conditions, and, through decisional protocols, establish the degree of appropriateness of the investigations/exam to perform for each patient, based on current state of risk.
The aim of this study is to evaluate, through machine learning tools, the accuracy of clinical data, neuropsychological assessment, personality traits, cognitive reserve, genetic factors, cerebrospinal fluid (CSF) neurodegeneration biomarkers and features from EEG and event-related potentials (ERP) in predicting conversion from SCD condition, to Mild Cognitive Impairment (MCI) and AD.
All participants will undergo a comprehensive familial and clinical history, general and neurological examination, extensive neuropsychological battery (about 19 tests exploring all cognitive domains: memory, attention, executive functions, language, praxis), estimation of premorbid intelligence (TIB - Test di Intelligenza Breve, an Italian version of the National Adult Reading Test - NART), personality traits (Big Five Factors Questionnaire - BFFQ), and leisure activities evaluation (structured interviewed regarding participation in intellectual, sporting and social activities) as well as assessment of depression (Hamilton Depression Rating Scale - HDRS). Moreover, all patients will undergo a CSF analysis to assess established biomarkers (Aβ42, total tau, p-tau) and blood samples for DNA analysis will be collected to identify the Apolipoprotein E (APOE) and brain-derived neurotrophic factor (BDNF) genotypes. In particular, will be analyzed three different single nucleotide polymorphisms (SNPs):
- BDNF SNP Val66Met (valine-methionine substitution) was already associated with poorer episodic memory and abnormal hippocampal activation assayed with MRI
- APOE gene rs429358 and rs7412 that are involved in the Amyloid plaque formation Only clinical and neuropsychological assessment are repeated yearly in order to evaluate progression of decline.
The sub-sample will be selected including all new cases of SCD included in the study (about 50), all subjects converted to MCI (about 25), and all patients, already studied, who report a subjective cognitive disorder for less than 10 years (about 75).
This selected sub-sample will also perform additional investigations: CSF biomarkers, resting state EEG recordings and ERP registration.
For about 150 subject the EEG activity will be recorded. The participants will be administered an ERP test battery with concurrently recorded EEG. Analysis of EEG data, in particular, will start with a standardized early-stage EEG processing pipeline (PREP Pipeline) focusing on high-filtering at 1 Hz, the identification of bad channels and the calculation of a robust average reference. The investigators will perform signal epoching using fixed length epochs for resting state measurements, and stimulus-locked epochs for signals acquired during tasks. Epochs containing artifactual signal will be removed with a semi-automatic procedure. The investigators will then apply independent component analysis (ICA) to the data, followed by a semiautomatic detection of artifactual components based on measures of autocorrelation, correlation with EOG electrode, focal channel topography and quality of mono-source dipole fitting. Finally, the investigators will compute power features at the sensor space, i.e. frequency bands powers, and linear/non-linear functional connectivity metrics, i.e. direct transfer function and mutual information, at the source level after a source reconstruction procedure, i.e. Low Resolution Brain Electromagnetic Tomography (LORETA) method (Pascual-Marqui et, al 2002).
Machine learning analysis will proceed as follows. The first analysis will include all the patients that were diagnosed with SCD in the preliminary work. The investigators will define a set of multi-modal features including all the 19 neuropsychological tests, a selection of the personality assessments and the genetic profile. The investigators will define a common metrics based on the dispersion of each single dimension of the profile and then they will train a machine learning algorithm to associate each profile "vector" to the associated evolution of the disease after a fixed time (at first the possible categories will be only SCD, MCI, AD with no further sublevels, but this can be improved in further rounds). First, the investigators will perform this classification with standard machine learning procedures as support vector machine (SVM, using binary decisions trees) and k-nearest neighbors (kNN). Then they will exploit the fact that neurophysiological assessments are repeated yearly (see above) to use the SuStaIn algorithm previously applied to neuroimaging data (see state of the art and Young 2018). Briefly, the algorithm z-scores each dimension of the profile and models with a piece-wise linear function the different paths of accumulations of each marker, i.e. the progression from healthy to abnormal values. This approach does not only outperform standard algorithms in predicting the final condition of the subjects based on the starting profile but highlight the different paths that can lead to the same outcome. In a separate set of analysis, the investigators will follow a deep learning approach, using exactly the same subject profiles to train a multi-level feedforward artificial neural network (ANN) predicting the condition of the patient after a fixed time. The networks will be trained with standard gradient descent and backpropagation techniques and by means of dropout and batch normalization procedures the investigators will obtain robust automatic classification results. Comparing SuStaIn and ANN classification performance they will decide the most convenient approach for the task. Moreover, they will apply standard dimensionality reduction techniques to extract the most salient features and repeat the procedure described above to assess whether it is possible to achieve the same results with a subset of the screenings.
The selected approach will be then repeated to the novel patients recruited during PREVIEW and those undergoing follow up analysis during the project. The only difference will be the novel set of factors included in the analysis, including all the data used in the first version but also BDNF, CSF biomarkers, and the novel features extracted from resting state EEG recordings and ERP. This will require defining a second multi-modal metrics across all features, and a consequent reshaping and retraining of the machine learning network. As described above, even for the second version of the algorithm the investigators will aim at defining the minimal set of features achieving the optimal performance. The final outcome of the algorithm will provide a prediction of the evolution of the condition for each patient based on his/her complete profile.
- Being tested
- Genetic analysis of APOE and BDNF genes., EEG recording, CSF collection and AD biomarker measurement, Neuropsychological evaluation, Assessment of cognitive reserve, depression, personality traits and leisure activities
- Keywords
- Dementia, Cognitive reserve, machine learning, deep learning, precision medicine, Electroencephalogram, Event Related Potential, Cerebrospinal Fluid biomarker, Apolipoprotein E, Brain-derived neurotrophic factor
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic analysis of APOE and BDNF genes.Genetic
The three SNPs (rs429358, rs7412 and rs6265 on APOE and BDNF genes respectively) will be analyzed by the polymerase chain reaction (PCR) on genomic DNA and with the analysis of melting curves (HRMA) using the Rotor-Gene 6,000 (Rotor-Gene, Corbett Research, Mortlake, Australia).
EEG recordingDiagnostic test
The EEG activity will be recorded continuously from 19 sites by using electrodes set in an elastic cap and positioned according to the 10-20 international system. The recording will be referenced to the common average of all electrodes, excluding Fp1 and Fp2. Re-referencing will be done prior to the EEG artifact detection and analysis. Data will be recorded with a band-pass filter of 0.3-70 Hz and digitized at a sampling rate of 512 Hz and analogue-digital precision was 16 bits (Gal-Nt, EbNeuro®, Florence, Italy). Horizontal and vertical eye movements will be detected by electrooculogram (EOG). Subjects will be sat in a reclined chair for approximately 20 min. Data will be collected at a sampling rate of 256 Hz, with a common mode rejection ratio of 105 dB (decibel), and the following band pass characteristics: 0.1 Hz high-pass filter, 100 Hz fifth order low-pass filter.
CSF collection and AD biomarker measurementDiagnostic test
The CSF samples will be collected by lumbar puncture, immediately centrifuged and stored at -80 °C until performing the analysis. Aβ42, Aβ42/Aβ40 ratio, t-tau, and p-tau will be measured using a chemiluminescent enzyme immunoassay (CLEIA) analyzer LUMIPULSE® G600 (Fujirebio, Tokyo, Japan).
Neuropsychological evaluationDiagnostic test
For extensive neuropsychological evaluation the investigators will use the following tools: global measurements (MMSE, Information-Memory-Concentration Test), tasks exploring verbal and spatial short- and long-term memory (Digit Span, Corsi Tapping Test, Five Words and Paired Words Acquisition and Recall after 10 min and 24 hr, Short Story Immediate and Delayed Recall), prospective memory (Rivermead Behavioral Memory Test), attention (Trail Making Test A, Dual Task), language (Token Test, naming pictures, Category Fluency Task, Phonemic Fluency Task), constructional praxis (Copying Drawings and Rey-Osterrieth complex figure) and executive function (Trail Making Test B, Stroop Test, Frontal Assessment Battery, Weigl Test).
To assess independent living skills, the investigators will use two structured interview: Activities of Daily Living Scale (ADL) and Instrumental Activities of Daily Living Scale (IADL).
Assessment of cognitive reserve, depression, personality traits and leisure activitiesDiagnostic test
In order to estimate premorbid intelligence, all cases will perform TIB test (Test di Intelligenza Breve), an Italian version of the National Adult Reading Test (NART).
To assess personality traits of the subjects, the investigators will use the Big Five Factors Questionnaire (BFFQ), that measures the five factors of emotional stability, energy, conscientiousness, agreeableness and openness to culture and experience.
For cognitive reserve. subjects will perform structured interviewed regarding participation in intellectual, sporting and social activities, in the course of their life.
The presence of depressive symptoms will be evaluated by means of the 22-item Hamilton Depression Rating Scale (HDRS).
Clinical-neuropsychological follow-upDiagnostic test
For follow-up assessment, each subject will perform a complete clinical evaluation, an extensive neuropsychological evaluation (27 test), assessment of independent living skills (ADL and IADL), estimation of premorbid intelligence (TIB test) and scale for depression (Hamilton Depression Rating Scale - HDRS).
ERP recordingDiagnostic test
For ERP acquisition the same EEG system that was used for EEG data acquisition will be used. The participants will be administered an ERP test battery with concurrently recorded EEG consisting of a 3-choice vigilance task (3CVT) designed to evaluate sustained attention and standard image recognition memory task (SIR) designed to evaluate attention, encoding, and image recognition memory. In the SIR, images will be chosen as stimuli to distinguish short term from semantic memory loss and extend previous results of image recognition ERP effects.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Subjective Cognitive Decline | Patients complaining about cognitive decline with normal functioning on the activities of daily living and unsatisfied criteria for MCI or dementia at baseline. Receives: Genetic: Genetic analysis of APOE and BDNF genes.; Diagnostic Test: EEG recording; Diagnostic Test: CSF collection and AD biomarker measurement; Diagnostic Test: Neuropsychological evaluation; Diagnostic Test: Assessment of cognitive reserve, depression, personality traits and leisure activities; Diagnostic Test: Clinical-neuropsychological follow-up; Diagnostic Test: ERP recording | |
| Patients with Mild Cognitive Impairment | Patients diagnosed with MCI Receives: Genetic: Genetic analysis of APOE and BDNF genes.; Diagnostic Test: EEG recording; Diagnostic Test: CSF collection and AD biomarker measurement; Diagnostic Test: Neuropsychological evaluation; Diagnostic Test: Assessment of cognitive reserve, depression, personality traits and leisure activities; Diagnostic Test: Clinical-neuropsychological follow-up; Diagnostic Test: ERP recording | |
| Healthy controls | Not described Receives: Diagnostic Test: EEG recording; Diagnostic Test: ERP recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical diagnosis of MCI in patients diagnosed with SCD
Patients diagnosed with SCD at baseline will be followed-up every six months by neurological evaluation and every twelve months by neuropsychological examination in order to detect progression to MCI according to National Institute on Aging and Alzheimer's Association (NIA-AA) criteria (Albert et al. 2011)
Measured: three years
Clinical diagnosis of AD in patients diangosed with SCD and MCI
Patients diagnosed with SCD or MCI at baseline will be followed-up every six months by neurological evaluation and every twelve months by neuropsychological examination in order to detect progression to AD according to NIA-AA criteria (Mc Khann et al. 2011)
Measured: three years
Secondary outcomes (1)
Variations in neuropsychological scores
All included patients will be evaluated every 12 months by extensive neuropsychological examinations in order to identify variations in cognitive performances.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Oct 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies 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
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi ETS, University of Florence, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Responsible party
- Principal investigator, Valentina Bessi, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Valentina Bessi, MD, PhD, Principal investigator, Research and Innovation Centre for Dementia-CRIDEM, AOU Careggi, Florence, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569083
- Sponsor's protocol ID
- 20RSVB
- Acronym
- PREVIEW
- Status last verified
- Oct 2022
- First submitted
- 24 Aug 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: An anonymized data that support the findings of this study will be shared by request from any qualified investigator.
Publications
Giacomucci G, Mazzeo S, Bagnoli S, Casini M, Padiglioni S, Polito C, Berti V, Balestrini J, Ferrari C, Lombardi G, Ingannato A, Sorbi S, Nacmias B, Bessi V. Matching Clinical Diagnosis and Amyloid Biomarkers in Alzheimer's Disease and Frontotemporal Dementia. J Pers Med. 2021 Jan 14;11(1):47. doi: 10.3390/jpm11010047.
PubMed 33466854Mazzeo S, Bessi V, Bagnoli S, Giacomucci G, Balestrini J, Padiglioni S, Tomaiuolo G, Ingannato A, Ferrari C, Bracco L, Sorbi S, Nacmias B. Dual Effect of PER2 C111G Polymorphism on Cognitive Functions across Progression from Subjective Cognitive Decline to Mild Cognitive Impairment. Diagnostics (Basel). 2021 Apr 18;11(4):718. doi: 10.3390/diagnostics11040718.
PubMed 33919572Bessi V, Balestrini J, Bagnoli S, Mazzeo S, Giacomucci G, Padiglioni S, Piaceri I, Carraro M, Ferrari C, Bracco L, Sorbi S, Nacmias B. Influence of ApoE Genotype and Clock T3111C Interaction with Cardiovascular Risk Factors on the Progression to Alzheimer's Disease in Subjective Cognitive Decline and Mild Cognitive Impairment Patients. J Pers Med. 2020 May 29;10(2):45. doi: 10.3390/jpm10020045.
PubMed 32485802Mazzeo S, Padiglioni S, Bagnoli S, Bracco L, Nacmias B, Sorbi S, Bessi V. The dual role of cognitive reserve in subjective cognitive decline and mild cognitive impairment: a 7-year follow-up study. J Neurol. 2019 Feb;266(2):487-497. doi: 10.1007/s00415-018-9164-5. Epub 2019 Jan 2.
PubMed 30604054Giacomucci G, Mazzeo S, Padiglioni S, Bagnoli S, Belloni L, Ferrari C, Bracco L, Nacmias B, Sorbi S, Bessi V. Gender differences in cognitive reserve: implication for subjective cognitive decline in women. Neurol Sci. 2022 Apr;43(4):2499-2508. doi: 10.1007/s10072-021-05644-x. Epub 2021 Oct 8.
PubMed 34625855Mazzeo S, Bessi V, Padiglioni S, Bagnoli S, Bracco L, Sorbi S, Nacmias B. KIBRA T allele influences memory performance and progression of cognitive decline: a 7-year follow-up study in subjective cognitive decline and mild cognitive impairment. Neurol Sci. 2019 Aug;40(8):1559-1566. doi: 10.1007/s10072-019-03866-8. Epub 2019 Apr 5.
PubMed 30953258Bessi V, Mazzeo S, Padiglioni S, Piccini C, Nacmias B, Sorbi S, Bracco L. From Subjective Cognitive Decline to Alzheimer's Disease: The Predictive Role of Neuropsychological Assessment, Personality Traits, and Cognitive Reserve. A 7-Year Follow-Up Study. J Alzheimers Dis. 2018;63(4):1523-1535. doi: 10.3233/JAD-171180.
PubMed 29782316Mazzeo S, Padiglioni S, Bagnoli S, Carraro M, Piaceri I, Bracco L, Nacmias B, Sorbi S, Bessi V. Assessing the effectiveness of subjective cognitive decline plus criteria in predicting the progression to Alzheimer's disease: an 11-year follow-up study. Eur J Neurol. 2020 May;27(5):894-899. doi: 10.1111/ene.14167. Epub 2020 Mar 8.
PubMed 32043740Amoroso N, Diacono D, Fanizzi A, La Rocca M, Monaco A, Lombardi A, Guaragnella C, Bellotti R, Tangaro S; Alzheimer's Disease Neuroimaging Initiative. Deep learning reveals Alzheimer's disease onset in MCI subjects: Results from an international challenge. J Neurosci Methods. 2018 May 15;302:3-9. doi: 10.1016/j.jneumeth.2017.12.011. Epub 2017 Dec 26.
PubMed 29287745Bansal D. et al. Comparative Analysis of Various Machine Learning Algorithms for Detecting Dementia - Procedia Computer Science (2018) 132: 1497-1502
Gouw AA, Alsema AM, Tijms BM, Borta A, Scheltens P, Stam CJ, van der Flier WM. EEG spectral analysis as a putative early prognostic biomarker in nondemented, amyloid positive subjects. Neurobiol Aging. 2017 Sep;57:133-142. doi: 10.1016/j.neurobiolaging.2017.05.017. Epub 2017 Jun 1.
PubMed 28646686Guillem F, Rougier A, Claverie B. Short- and long-delay intracranial ERP repetition effects dissociate memory systems in the human brain. J Cogn Neurosci. 1999 Jul;11(4):437-58. doi: 10.1162/089892999563526.
PubMed 10471850Amato LG, Lassi M, Grippo A, Moschini V, Giacomucci G, Padiglioni S, Morinelli C, Nacmias B, Mazzoni A, Bessi V, Vergani AA. EEG recordings during visuo-attentive task reduce sex bias in Alzheimer's disease diagnosis. Alzheimers Dement (N Y). 2026 Apr 6;12(2):e70245. doi: 10.1002/trc2.70245. eCollection 2026 Apr-Jun.
PubMed 41953573Mazzeo S, Lassi M, Padiglioni S, Vergani AA, Moschini V, Scarpino M, Giacomucci G, Burali R, Morinelli C, Fabbiani C, Galdo G, Amato LG, Bagnoli S, Emiliani F, Ingannato A, Nacmias B, Sorbi S, Grippo A, Mazzoni A, Bessi V. Towards the development of a management protocol for subjective cognitive decline: Insights from a cross-sectional and longitudinal analysis of multimodal data from a memory clinic. J Alzheimers Dis. 2026 Mar;110(2):728-745. doi: 10.1177/13872877261416117. Epub 2026 Jan 28.
PubMed 41603334Amato LG, Lassi M, Vergani AA, Carpaneto J, Mazzeo S, Moschini V, Burali R, Salvestrini G, Fabbiani C, Giacomucci G, Galdo G, Morinelli C, Emiliani F, Scarpino M, Padiglioni S, Nacmias B, Sorbi S, Grippo A, Bessi V, Mazzoni A. Digital twins and non-invasive recordings enable early diagnosis of Alzheimer's disease. Alzheimers Res Ther. 2025 May 31;17(1):125. doi: 10.1186/s13195-025-01765-z.
PubMed 40450374
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRedicting the EVolution of SubjectIvE Cognitive Decline to Alzheimer's Disease With Machine Learning
- ClinicalTrials.gov ID
- NCT05569083
- Acronym / sponsor ID
- PREVIEW / 20RSVB
- Keywords
- Dementia, Cognitive reserve, machine learning, deep learning, precision medicine, Electroencephalogram, Event Related Potential, Cerebrospinal Fluid biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi ETS, University of Florence, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 6 Oct 2022 (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.
Alzheimer's disease (AD) has a presymptomatic course which can last from several years to decades. Identification of subjects at an early stage is crucial for therapeutic intervention and possible prevention of cognitive decline. Current research is focused on identifying characteristics of the early stages of AD and several concepts have been developed to that end.
Subjective cognitive decline (SCD) is defined as a self-experienced persistent decline in cognitive capacity in comparison with the subject's previously normal status, during which the subject has normal age-, gender-, and education-adjusted performance on standardized cognitive tests. SCD is not related to current cognitive impairment, however it has been considered for its potential role as risk factors for AD.
The aim of this study is to evaluate, through machine learning tools, the accuracy data, neuropsychological assessment, personality traits, cognitive reserve, genetic factors, cerebrospinal fluid (CSF) neurodegeneration biomarkers, EEG and Event Related Potential recordings in predicting conversion from SCD condition, to Mild Cognitive Impairment (MCI) and AD.
Detailed description
The Regional Reference Center for Alzheimer's Disease and Cognitive Disorders of Careggi Hospital, Florence, started about 25 years ago to collect clinical, neuropsychological, personality and lifestyles data for patients with of Subjective Cognitive Decline (SCD). Starting from these data the aim of the present study is to increase the number of variables collected on SCD subjects and expand the clinical follow-up to delineate more accurate pathway of disease and to identify very early subject at risk of conversion in Alzheimer's Disease (AD).
The advantages of detection of cognitive impairment at the early stages are critical. Such detection has traditionally been performed manually by one or more clinicians based on reports and test results. Machine learning algorithms offer a method of detection that may provide an automated process and valuable insights into diagnosis and classification. With this tool clinicians could design optimal screenings to predict, already at the stage of SCD, possible evolutions of the patient's conditions, and, through decisional protocols, establish the degree of appropriateness of the investigations/exam to perform for each patient, based on current state of risk.
The aim of this study is to evaluate, through machine learning tools, the accuracy of clinical data, neuropsychological assessment, personality traits, cognitive reserve, genetic factors, cerebrospinal fluid (CSF) neurodegeneration biomarkers and features from EEG and event-related potentials (ERP) in predicting conversion from SCD condition, to Mild Cognitive Impairment (MCI) and AD.
All participants will undergo a comprehensive familial and clinical history, general and neurological examination, extensive neuropsychological battery (about 19 tests exploring all cognitive domains: memory, attention, executive functions, language, praxis), estimation of premorbid intelligence (TIB - Test di Intelligenza Breve, an Italian version of the National Adult Reading Test - NART), personality traits (Big Five Factors Questionnaire - BFFQ), and leisure activities evaluation (structured interviewed regarding participation in intellectual, sporting and social activities) as well as assessment of depression (Hamilton Depression Rating Scale - HDRS). Moreover, all patients will undergo a CSF analysis to assess established biomarkers (Aβ42, total tau, p-tau) and blood samples for DNA analysis will be collected to identify the Apolipoprotein E (APOE) and brain-derived neurotrophic factor (BDNF) genotypes. In particular, will be analyzed three different single nucleotide polymorphisms (SNPs):
- BDNF SNP Val66Met (valine-methionine substitution) was already associated with poorer episodic memory and abnormal hippocampal activation assayed with MRI
- APOE gene rs429358 and rs7412 that are involved in the Amyloid plaque formation Only clinical and neuropsychological assessment are repeated yearly in order to evaluate progression of decline.
The sub-sample will be selected including all new cases of SCD included in the study (about 50), all subjects converted to MCI (about 25), and all patients, already studied, who report a subjective cognitive disorder for less than 10 years (about 75).
This selected sub-sample will also perform additional investigations: CSF biomarkers, resting state EEG recordings and ERP registration.
For about 150 subject the EEG activity will be recorded. The participants will be administered an ERP test battery with concurrently recorded EEG. Analysis of EEG data, in particular, will start with a standardized early-stage EEG processing pipeline (PREP Pipeline) focusing on high-filtering at 1 Hz, the identification of bad channels and the calculation of a robust average reference. The investigators will perform signal epoching using fixed length epochs for resting state measurements, and stimulus-locked epochs for signals acquired during tasks. Epochs containing artifactual signal will be removed with a semi-automatic procedure. The investigators will then apply independent component analysis (ICA) to the data, followed by a semiautomatic detection of artifactual components based on measures of autocorrelation, correlation with EOG electrode, focal channel topography and quality of mono-source dipole fitting. Finally, the investigators will compute power features at the sensor space, i.e. frequency bands powers, and linear/non-linear functional connectivity metrics, i.e. direct transfer function and mutual information, at the source level after a source reconstruction procedure, i.e. Low Resolution Brain Electromagnetic Tomography (LORETA) method (Pascual-Marqui et, al 2002).
Machine learning analysis will proceed as follows. The first analysis will include all the patients that were diagnosed with SCD in the preliminary work. The investigators will define a set of multi-modal features including all the 19 neuropsychological tests, a selection of the personality assessments and the genetic profile. The investigators will define a common metrics based on the dispersion of each single dimension of the profile and then they will train a machine learning algorithm to associate each profile "vector" to the associated evolution of the disease after a fixed time (at first the possible categories will be only SCD, MCI, AD with no further sublevels, but this can be improved in further rounds). First, the investigators will perform this classification with standard machine learning procedures as support vector machine (SVM, using binary decisions trees) and k-nearest neighbors (kNN). Then they will exploit the fact that neurophysiological assessments are repeated yearly (see above) to use the SuStaIn algorithm previously applied to neuroimaging data (see state of the art and Young 2018). Briefly, the algorithm z-scores each dimension of the profile and models with a piece-wise linear function the different paths of accumulations of each marker, i.e. the progression from healthy to abnormal values. This approach does not only outperform standard algorithms in predicting the final condition of the subjects based on the starting profile but highlight the different paths that can lead to the same outcome. In a separate set of analysis, the investigators will follow a deep learning approach, using exactly the same subject profiles to train a multi-level feedforward artificial neural network (ANN) predicting the condition of the patient after a fixed time. The networks will be trained with standard gradient descent and backpropagation techniques and by means of dropout and batch normalization procedures the investigators will obtain robust automatic classification results. Comparing SuStaIn and ANN classification performance they will decide the most convenient approach for the task. Moreover, they will apply standard dimensionality reduction techniques to extract the most salient features and repeat the procedure described above to assess whether it is possible to achieve the same results with a subset of the screenings.
The selected approach will be then repeated to the novel patients recruited during PREVIEW and those undergoing follow up analysis during the project. The only difference will be the novel set of factors included in the analysis, including all the data used in the first version but also BDNF, CSF biomarkers, and the novel features extracted from resting state EEG recordings and ERP. This will require defining a second multi-modal metrics across all features, and a consequent reshaping and retraining of the machine learning network. As described above, even for the second version of the algorithm the investigators will aim at defining the minimal set of features achieving the optimal performance. The final outcome of the algorithm will provide a prediction of the evolution of the condition for each patient based on his/her complete profile.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Subjective Cognitive Decline | – | Genetic: Genetic analysis of APOE and BDNF genes., Diagnostic Test: EEG recording, Diagnostic Test: CSF collection and AD biomarker measurement, Diagnostic Test: Neuropsychological evaluation, Diagnostic Test: Assessment of cognitive reserve, depression, personality traits and leisure activities, Diagnostic Test: Clinical-neuropsychological follow-up, Diagnostic Test: ERP recordingPatients complaining about cognitive decline with normal functioning on the activities of daily living and unsatisfied criteria for MCI or dementia at baseline. |
| Patients with Mild Cognitive Impairment | – | Genetic: Genetic analysis of APOE and BDNF genes., Diagnostic Test: EEG recording, Diagnostic Test: CSF collection and AD biomarker measurement, Diagnostic Test: Neuropsychological evaluation, Diagnostic Test: Assessment of cognitive reserve, depression, personality traits and leisure activities, Diagnostic Test: Clinical-neuropsychological follow-up, Diagnostic Test: ERP recordingPatients diagnosed with MCI |
| Healthy controls | – | Diagnostic Test: EEG recording, Diagnostic Test: ERP recording |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators will include in the study, consecutive spontaneous subjects who self-referred to the Centre for Alzheimer's Disease and Adult Cognitive Disorders of Careggi Hospital in Florence. The investigators will include in the study 300 patients with SCD already selected and evaluated one time (baseline) or more (follow-up) in our clinic, and they will increase the baseline sample by adding new subjects with SCD or MCI.
Key inclusion criteria (3 listed)
- Complaining of cognitive decline with a duration of ≥ 6 months;
- Normal functioning on the Activities of Daily Living and the Instrumental Activities of Daily Living scales (Lawton and Brody, 1969);
- Unsatisfied criteria for dementia at baseline (DSM-V, American Psychiatric Association, 2013).
Key exclusion criteria (1 listed)
- History of head injury, current neurological and/or systemic disease, symptoms of psychosis, major depression, alcoholism or other substance abuse
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 |
|---|---|---|
| Genetic analysis of APOE and BDNF genes.The three SNPs (rs429358, rs7412 and rs6265 on APOE and BDNF genes respectively) will be analyzed by the polymerase chain reaction (PCR) on genomic DNA and with the analysis of melting curves (HRMA) using the Rotor-Gene 6,000 (Rotor-Gene, Corbett Research, Mortlake, Australia). | Genetic | Patients with Mild Cognitive Impairment, Patients with Subjective Cognitive Decline |
| EEG recordingThe EEG activity will be recorded continuously from 19 sites by using electrodes set in an elastic cap and positioned according to the 10-20 international system. The recording will be referenced to the common average of all electrodes, excluding Fp1 and Fp2. Re-referencing will be done prior to the EEG artifact detection and analysis. Data will be recorded with a band-pass filter of 0.3-70 Hz and digitized at a sampling rate of 512 Hz and analogue-digital precision was 16 bits (Gal-Nt, EbNeuro®, Florence, Italy). Horizontal and vertical eye movements will be detected by electrooculogram (EOG). Subjects will be sat in a reclined chair for approximately 20 min. Data will be collected at a sampling rate of 256 Hz, with a common mode rejection ratio of 105 dB (decibel), and the following band pass characteristics: 0.1 Hz high-pass filter, 100 Hz fifth order low-pass filter. | Diagnostic test | Healthy controls, Patients with Mild Cognitive Impairment, Patients with Subjective Cognitive Decline |
| CSF collection and AD biomarker measurementThe CSF samples will be collected by lumbar puncture, immediately centrifuged and stored at -80 °C until performing the analysis. Aβ42, Aβ42/Aβ40 ratio, t-tau, and p-tau will be measured using a chemiluminescent enzyme immunoassay (CLEIA) analyzer LUMIPULSE® G600 (Fujirebio, Tokyo, Japan). | Diagnostic test | Patients with Mild Cognitive Impairment, Patients with Subjective Cognitive Decline |
| Neuropsychological evaluationFor extensive neuropsychological evaluation the investigators will use the following tools: global measurements (MMSE, Information-Memory-Concentration Test), tasks exploring verbal and spatial short- and long-term memory (Digit Span, Corsi Tapping Test, Five Words and Paired Words Acquisition and Recall after 10 min and 24 hr, Short Story Immediate and Delayed Recall), prospective memory (Rivermead Behavioral Memory Test), attention (Trail Making Test A, Dual Task), language (Token Test, naming pictures, Category Fluency Task, Phonemic Fluency Task), constructional praxis (Copying Drawings and Rey-Osterrieth complex figure) and executive function (Trail Making Test B, Stroop Test, Frontal Assessment Battery, Weigl Test). To assess independent living skills, the investigators will use two structured interview: Activities of Daily Living Scale (ADL) and Instrumental Activities of Daily Living Scale (IADL). | Diagnostic test | Patients with Mild Cognitive Impairment, Patients with Subjective Cognitive Decline |
| Assessment of cognitive reserve, depression, personality traits and leisure activitiesIn order to estimate premorbid intelligence, all cases will perform TIB test (Test di Intelligenza Breve), an Italian version of the National Adult Reading Test (NART). To assess personality traits of the subjects, the investigators will use the Big Five Factors Questionnaire (BFFQ), that measures the five factors of emotional stability, energy, conscientiousness, agreeableness and openness to culture and experience. For cognitive reserve. subjects will perform structured interviewed regarding participation in intellectual, sporting and social activities, in the course of their life. The presence of depressive symptoms will be evaluated by means of the 22-item Hamilton Depression Rating Scale (HDRS). | Diagnostic test | Patients with Mild Cognitive Impairment, Patients with Subjective Cognitive Decline |
| Clinical-neuropsychological follow-upFor follow-up assessment, each subject will perform a complete clinical evaluation, an extensive neuropsychological evaluation (27 test), assessment of independent living skills (ADL and IADL), estimation of premorbid intelligence (TIB test) and scale for depression (Hamilton Depression Rating Scale - HDRS). | Diagnostic test | Patients with Mild Cognitive Impairment, Patients with Subjective Cognitive Decline |
| ERP recordingFor ERP acquisition the same EEG system that was used for EEG data acquisition will be used. The participants will be administered an ERP test battery with concurrently recorded EEG consisting of a 3-choice vigilance task (3CVT) designed to evaluate sustained attention and standard image recognition memory task (SIR) designed to evaluate attention, encoding, and image recognition memory. In the SIR, images will be chosen as stimuli to distinguish short term from semantic memory loss and extend previous results of image recognition ERP effects. | Diagnostic test | Healthy controls, Patients with Mild Cognitive Impairment, Patients with Subjective Cognitive Decline |
Primary outcome
Clinical diagnosis of MCI in patients diagnosed with SCD
Time frame: three years
Patients diagnosed with SCD at baseline will be followed-up every six months by neurological evaluation and every twelve months by neuropsychological examination in order to detect progression to MCI according to National Institute on Aging and Alzheimer's Association (NIA-AA) criteria (Albert et al. 2011)
Clinical diagnosis of AD in patients diangosed with SCD and MCI
Time frame: three years
Patients diagnosed with SCD or MCI at baseline will be followed-up every six months by neurological evaluation and every twelve months by neuropsychological examination in order to detect progression to AD according to NIA-AA criteria (Mc Khann et al. 2011)
1 secondary outcome
Variations in neuropsychological scores
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Background: PubMed 33466854Giacomucci G, Mazzeo S, Bagnoli S, Casini M, Padiglioni S, Polito C, Berti V, Balestrini J, Ferrari C, Lombardi G, Ingannato A, Sorbi S, Nacmias B, Bessi V. Matching Clinical Diagnosis and Amyloid Biomarkers in Alzheimer's Disease and Frontotemporal Dementia. J Pers Med. 2021 Jan 14;11(1):47. doi: 10.3390/jpm11010047.
- Background: PubMed 33919572Mazzeo S, Bessi V, Bagnoli S, Giacomucci G, Balestrini J, Padiglioni S, Tomaiuolo G, Ingannato A, Ferrari C, Bracco L, Sorbi S, Nacmias B. Dual Effect of PER2 C111G Polymorphism on Cognitive Functions across Progression from Subjective Cognitive Decline to Mild Cognitive Impairment. Diagnostics (Basel). 2021 Apr 18;11(4):718. doi: 10.3390/diagnostics11040718.
- Background: PubMed 32485802Bessi V, Balestrini J, Bagnoli S, Mazzeo S, Giacomucci G, Padiglioni S, Piaceri I, Carraro M, Ferrari C, Bracco L, Sorbi S, Nacmias B. Influence of ApoE Genotype and Clock T3111C Interaction with Cardiovascular Risk Factors on the Progression to Alzheimer's Disease in Subjective Cognitive Decline and Mild Cognitive Impairment Patients. J Pers Med. 2020 May 29;10(2):45. doi: 10.3390/jpm10020045.
- Background: PubMed 30604054Mazzeo S, Padiglioni S, Bagnoli S, Bracco L, Nacmias B, Sorbi S, Bessi V. The dual role of cognitive reserve in subjective cognitive decline and mild cognitive impairment: a 7-year follow-up study. J Neurol. 2019 Feb;266(2):487-497. doi: 10.1007/s00415-018-9164-5. Epub 2019 Jan 2.
- Background: PubMed 34625855Giacomucci G, Mazzeo S, Padiglioni S, Bagnoli S, Belloni L, Ferrari C, Bracco L, Nacmias B, Sorbi S, Bessi V. Gender differences in cognitive reserve: implication for subjective cognitive decline in women. Neurol Sci. 2022 Apr;43(4):2499-2508. doi: 10.1007/s10072-021-05644-x. Epub 2021 Oct 8.
- Background: PubMed 30953258Mazzeo S, Bessi V, Padiglioni S, Bagnoli S, Bracco L, Sorbi S, Nacmias B. KIBRA T allele influences memory performance and progression of cognitive decline: a 7-year follow-up study in subjective cognitive decline and mild cognitive impairment. Neurol Sci. 2019 Aug;40(8):1559-1566. doi: 10.1007/s10072-019-03866-8. Epub 2019 Apr 5.
- Background: PubMed 29782316Bessi V, Mazzeo S, Padiglioni S, Piccini C, Nacmias B, Sorbi S, Bracco L. From Subjective Cognitive Decline to Alzheimer's Disease: The Predictive Role of Neuropsychological Assessment, Personality Traits, and Cognitive Reserve. A 7-Year Follow-Up Study. J Alzheimers Dis. 2018;63(4):1523-1535. doi: 10.3233/JAD-171180.
- Background: PubMed 32043740Mazzeo S, Padiglioni S, Bagnoli S, Carraro M, Piaceri I, Bracco L, Nacmias B, Sorbi S, Bessi V. Assessing the effectiveness of subjective cognitive decline plus criteria in predicting the progression to Alzheimer's disease: an 11-year follow-up study. Eur J Neurol. 2020 May;27(5):894-899. doi: 10.1111/ene.14167. Epub 2020 Mar 8.
- Background: PubMed 29287745Amoroso N, Diacono D, Fanizzi A, La Rocca M, Monaco A, Lombardi A, Guaragnella C, Bellotti R, Tangaro S; Alzheimer's Disease Neuroimaging Initiative. Deep learning reveals Alzheimer's disease onset in MCI subjects: Results from an international challenge. J Neurosci Methods. 2018 May 15;302:3-9. doi: 10.1016/j.jneumeth.2017.12.011. Epub 2017 Dec 26.
- BackgroundBansal D. et al. Comparative Analysis of Various Machine Learning Algorithms for Detecting Dementia - Procedia Computer Science (2018) 132: 1497-1502
- Background: PubMed 28646686Gouw AA, Alsema AM, Tijms BM, Borta A, Scheltens P, Stam CJ, van der Flier WM. EEG spectral analysis as a putative early prognostic biomarker in nondemented, amyloid positive subjects. Neurobiol Aging. 2017 Sep;57:133-142. doi: 10.1016/j.neurobiolaging.2017.05.017. Epub 2017 Jun 1.
- Background: PubMed 10471850Guillem F, Rougier A, Claverie B. Short- and long-delay intracranial ERP repetition effects dissociate memory systems in the human brain. J Cogn Neurosci. 1999 Jul;11(4):437-58. doi: 10.1162/089892999563526.
- Individual participant dataSharing planned: Undecided. An anonymized data that support the findings of this study will be shared by request from any qualified investigator.
Related trials for Cognitive Decline
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
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.
Valentina Bessi, MD, PhD principal investigator
Research and Innovation Centre for Dementia-CRIDEM, AOU Careggi, Florence, Italy
4 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 Decline and Mild Cognitive Impairment, run by Azienda Ospedaliero-Universitaria Careggi at 4 sites 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 1 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 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Contact Valentina Bessi, MD, PhD (+393496096308, valentina.bessi@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical diagnosis of MCI in patients diagnosed with SCD (time frame: three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05569083, which also lists 16 linked publications.
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 7 Oct 2022.