Alzheimer DiseaseNCT06826157
The Role of Advanced Electroencephalographic Data as Marker of Pathology and Prognosis in Primary Dementias
A study testing Electroencephalogram, 3 Tesla MRI and Apolipoprotein E genetic test in people with Alzheimer Disease and Lewy Body Dementia (LBD), run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The study aims to use advanced brainwave recordings of electroencephalogram (EEG) to understand early signs of Alzheimer's disease (AD) in people with mild memory problems, known as amnestic Mild Cognitive Impairment (MCI). The goals of the study are to: 1. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Lewy Body Dementia (LBD), Mild Alzheimer Disease
- What is being tested?
- Electroencephalogram, 3 Tesla MRI and Apolipoprotein E genetic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteItaly
- Study dates
- 5 Nov 2021to 1 Jan 2027
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- right-handed participants;
- monolingual native Italian speakers;
- age between 50-85 years old;
- normal or corrected-to-normal visual acuity;
- oral and written informed consent to study participation.
- if assuming psychotropic drugs (i.e., benzodiazepines, antipsychotics, antidepressants), they should be at stable dosage for more than 4 weeks.
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- diagnosis of amnestic MCI;
- mini Mental State Examination (MMSE) score ≥ 24;
- if assuming anticholinesterase inhibitors (i.e., galantamine, rivastigmine, donepezil) or memantine, they should be at stable dosage for more than 4 weeks;
- available CSF AD biomarkers.
- diagnosis of AD dementia, FTD or LBD.
- MMSE score ≥ 15;
- if assuming anticholinesterase inhibitors (i.e., galantamine, rivastigmine, donepezil) or memantine, they should be at stable dosage for more than 4 weeks.
Who cannot join
- secondary forms of cognitive impairment on the basis of historical data, neurologic examination, and cerebral neuroimaging findings;
- very rapid cognitive decline that occurs over weeks or months, typically indicative of prion disease, neoplasm or metabolic disorders;
- history of other systemic (including systemic neoplasms in the last 3 years and abnormal hepatorenal functions), neurologic (including epilepsy), psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations;
- alcohol and/or psychotropic drugs abuse;
- enrolment in clinical trials testing disease-modifying drugs for AD during study;
- contraindications to MRI study:
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- Cardiac pacemakers or other types of cardiac catheters;
- metal splinters or fragments;
- metal prostheses not compatible with the magnetic field generated during MRI;
- claustrophobia.
- Women who are pregnant or intending to become pregnant during the study; breastfeeding women.
- History of other systemic (including systemic neoplasms in the last 3 years and abnormal hepatorenal functions), neurologic (including epilepsy), psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations;
- alcohol and/or psychotropic drugs abuse;
- contraindications to MRI study (see above);
- women who are pregnant or intending to become pregnant during the study; breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing the Role of Advanced Electroencephalographic Data as Marker of Pathology and Prognosis in Primary Dementias
The study aims to use advanced brainwave recordings of electroencephalogram (EEG) to understand early signs of Alzheimer's disease (AD) in people with mild memory problems, known as amnestic Mild Cognitive Impairment (MCI). The goals of the study are to:
- Find early markers of Alzheimer by analyzing EEG recordings, the researchers hope to identify patterns that indicate the presence of Alzheimer's disease. They will compare these patterns with other brain scans, like Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) scans, and look at different biological markers in the participants' spinal fluid and genetic data.
- Predict the risk of Alzheimer's disease. The study will try to find EEG patterns that can predict whether someone with MCI will develop full-blown Alzheimer's disease. The aim is to create a system that combines EEG data with other brain scans and genetic information to better understand the risk of disease progression.
- Track changes over time: The research will also monitor changes in brain activity and structure over time to understand how Alzheimer's disease progresses.
In addition to studying people with MCI, the researchers will also look at EEG patterns in people with mild Alzheimer's disease (MILD AD), frontotemporal dementia (FTD), and Lewy-body dementia (LBD) to see how these patterns differ across various brain conditions. This could help improve the accuracy of diagnosing these diseases and understanding their link to genetic factors.
Read the detailed description
The main aim of the project is to examine resting-state high definition EEG cortical sources of participants diagnosed with amnestic MCI with the goal of:
- exploring EEG-markers of Alzheimer's disease pathology and their relationships with both conventional and non-conventional brain MRI data. Researchers will explore these relationships after grouping participants according to their cerebrospinal fluid (CSF) biomarkers profile.
Researchers will explain further relationships through brain Positron Tomography Emission with fluorodeoxyglucose (PET-FDG) data performed during clinical diagnostic work-up and with Apolipoprotein E (APOE) gene profile.
- prospectively identifying EEG-markers predictive of clinical conversion to full-blown AD dementia and defining an algorithm for risk stratification by combining them with brain MRI, brain FDG-PET and genetic data;
- assessing the longitudinal changes of electrophysiological and MRI signals throughout the AD neuropathology progression;
The secondary aim of the project is to assess the accuracy of the Alzheimer-related EEG signal patterns identified in the MCI group. This will be done by comparing the EEG data with the APOE genetic information in a group of patients diagnosed with mild dementia due to Alzheimer's disease, frontotemporal dementia and Lewy-Body dementia
- Conditions
- Alzheimer Disease, Lewy Body Dementia (LBD), Mild Alzheimer Disease, Frontotemporal Dementia (FTD), Mild Cognitive Impairment (MCI), Healthy Subjects
- Being tested
- Electroencephalogram, 3 Tesla MRI, Apolipoprotein E genetic test
- Keywords
- high-definition electroencephalogram, Brain Magnetic Resonance Imaging, Biomarker profile, Positron Emission Tomography, Apolipoprotein E, Mild Cognitive Impairment, Frontotemporal dementia, Lewy-body dementia, Dementia
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease, Frontotemporal Dementia, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalogramDiagnostic test
EEGs will be acquired to explore progressive alteration of EEG patterns throughout the neuropathology progression.
3 Tesla MRIDiagnostic test
MRI evaluations will be performed to investigate structural alterations and resting state functional MRI (RS-fMRI) connectivity in participants. Longitudinal measures of cortical/subcortical atrophy and RS-fMRI connectivity will be assessed and their relationship with EEG parameters will be explored.
Apolipoprotein E genetic testGenetic
At baseline, a sample of blood will be collected to perform genetic analysis (APOE alleles) for all participants
| Study group | Role | What they receive |
|---|---|---|
| Clinical, EEG, brain MRI and genetic evaluations | Experimental | Participants will be screened to evaluate their eligibility. They will undergo clinical and cognitive assessments in addition to 32-channel EEG and 3 Tesla MRI at baseline (T0) and every year for 3 years. Furthermore, at baseline, a known genetic risk factors for AD will be explored (e., APOE gene profile). Receives: Diagnostic Test: Electroencephalogram; Diagnostic Test: 3 Tesla MRI; Genetic: Apolipoprotein E genetic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical source densities in resting-state EEG for mild cognitive impairment: Markers of differential diagnosis and dementia conversion prediction
Source densities in resting-state high-definition EEG in patients with mild cognitive impairment, measured as cortical markers for differential diagnosis of dementias and prediction of conversion to full-blown dementia
Measured: 36 months
Secondary outcomes (3)
Accuracy of EEG markers in distinguishing Alzheimer's disease from other dementias measured by sensivity
Diagnostic accuracy of EEG markers in distinguishing Alzheimer's disease (AD) from other dementias (e.g., frontotemporal dementia, Lewy-body dementia), measured as the ability to correctly identify cases that are not Alzheimer's (e.g., frontotemporal dementia, Lewy-body dementia) compared to Alzheimer's cases.
Measured: 36 months
Accuracy of EEG markers in distinguishing Alzheimer's disease from other dementias measured by specifity
Diagnostic accuracy of EEG markers in distinguishing Alzheimer's disease (AD) from other dementias measured as the ability to correctly identify cases that are not Alzheimer's (e.g., frontotemporal dementia, Lewy-body dementia) compared to Alzheimer's cases
Measured: 36 months
Relationship between Alzheimer's disease and other dementias with APOE genetic variants
Relationship with APOE genetic variants (e.g., presence of APOE ε4 allele), quantified through cortical source densities reconstructed using sLORETA.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start5 Nov 2021
- Primary completion15 Apr 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention study, monocentric and multiparametric
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Massimo Filippi, IRCCS San Raffaele
- Investigators
- Massimo MF Filippi, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826157
- Sponsor's protocol ID
- DEMEEG
- Status last verified
- Feb 2025
- First submitted
- 4 Dec 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pascual-Marqui RD. Discrete, 3D distributed, linear imaging methods of electric neuronal activity. Part 1: exact, zero error localization. 2007.
Teipel SJ, Kurth J, Krause B, Grothe MJ; Alzheimer's Disease Neuroimaging Initiative. The relative importance of imaging markers for the prediction of Alzheimer's disease dementia in mild cognitive impairment - Beyond classical regression. Neuroimage Clin. 2015 May 21;8:583-93. doi: 10.1016/j.nicl.2015.05.006. eCollection 2015.
PubMed 26199870International AsD. World Alzheimer Report 2019: Attitudes to dementia. London: Alzheimer's Disease International, 2019
Cecchetti G, Agosta F, Basaia S, Cividini C, Cursi M, Santangelo R, Caso F, Minicucci F, Magnani G, Filippi M. Resting-state electroencephalographic biomarkers of Alzheimer's disease. Neuroimage Clin. 2021;31:102711. doi: 10.1016/j.nicl.2021.102711. Epub 2021 May 29.
PubMed 34098525McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7.
PubMed 28592453Rascovsky K, Hodges JR, Knopman D, Mendez MF, Kramer JH, Neuhaus J, van Swieten JC, Seelaar H, Dopper EG, Onyike CU, Hillis AE, Josephs KA, Boeve BF, Kertesz A, Seeley WW, Rankin KP, Johnson JK, Gorno-Tempini ML, Rosen H, Prioleau-Latham CE, Lee A, Kipps CM, Lillo P, Piguet O, Rohrer JD, Rossor MN, Warren JD, Fox NC, Galasko D, Salmon DP, Black SE, Mesulam M, Weintraub S, Dickerson BC, Diehl-Schmid J, Pasquier F, Deramecourt V, Lebert F, Pijnenburg Y, Chow TW, Manes F, Grafman J, Cappa SF, Freedman M, Grossman M, Miller BL. Sensitivity of revised diagnostic criteria for the behavioural variant of frontotemporal dementia. Brain. 2011 Sep;134(Pt 9):2456-77. doi: 10.1093/brain/awr179. Epub 2011 Aug 2.
PubMed 21810890McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
PubMed 21514250Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
PubMed 21514249Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
PubMed 29653606
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Role of Advanced Electroencephalographic Data as Marker of Pathology and Prognosis in Primary Dementias
- ClinicalTrials.gov ID
- NCT06826157
- Acronym / sponsor ID
- DEMEEG
- Conditions
- Alzheimer Disease, Lewy Body Dementia (LBD), Mild Alzheimer Disease, Frontotemporal Dementia (FTD), Mild Cognitive Impairment (MCI), Healthy Subjects
- Keywords
- high-definition electroencephalogram, Brain Magnetic Resonance Imaging, Biomarker profile, Positron Emission Tomography, Apolipoprotein E, Mild Cognitive Impairment, Frontotemporal dementia, Lewy-body dementia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to use advanced brainwave recordings of electroencephalogram (EEG) to understand early signs of Alzheimer's disease (AD) in people with mild memory problems, known as amnestic Mild Cognitive Impairment (MCI). The goals of the study are to:
- Find early markers of Alzheimer by analyzing EEG recordings, the researchers hope to identify patterns that indicate the presence of Alzheimer's disease. They will compare these patterns with other brain scans, like Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) scans, and look at different biological markers in the participants' spinal fluid and genetic data.
- Predict the risk of Alzheimer's disease. The study will try to find EEG patterns that can predict whether someone with MCI will develop full-blown Alzheimer's disease. The aim is to create a system that combines EEG data with other brain scans and genetic information to better understand the risk of disease progression.
- Track changes over time: The research will also monitor changes in brain activity and structure over time to understand how Alzheimer's disease progresses.
In addition to studying people with MCI, the researchers will also look at EEG patterns in people with mild Alzheimer's disease (MILD AD), frontotemporal dementia (FTD), and Lewy-body dementia (LBD) to see how these patterns differ across various brain conditions. This could help improve the accuracy of diagnosing these diseases and understanding their link to genetic factors.
Detailed description
The main aim of the project is to examine resting-state high definition EEG cortical sources of participants diagnosed with amnestic MCI with the goal of:
- exploring EEG-markers of Alzheimer's disease pathology and their relationships with both conventional and non-conventional brain MRI data. Researchers will explore these relationships after grouping participants according to their cerebrospinal fluid (CSF) biomarkers profile.
Researchers will explain further relationships through brain Positron Tomography Emission with fluorodeoxyglucose (PET-FDG) data performed during clinical diagnostic work-up and with Apolipoprotein E (APOE) gene profile.
- prospectively identifying EEG-markers predictive of clinical conversion to full-blown AD dementia and defining an algorithm for risk stratification by combining them with brain MRI, brain FDG-PET and genetic data;
- assessing the longitudinal changes of electrophysiological and MRI signals throughout the AD neuropathology progression;
The secondary aim of the project is to assess the accuracy of the Alzheimer-related EEG signal patterns identified in the MCI group. This will be done by comparing the EEG data with the APOE genetic information in a group of patients diagnosed with mild dementia due to Alzheimer's disease, frontotemporal dementia and Lewy-Body dementia
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention study, monocentric and multiparametric
| Arm | Type | Receives |
|---|---|---|
| Clinical, EEG, brain MRI and genetic evaluations | Experimental | Diagnostic Test: Electroencephalogram, Diagnostic Test: 3 Tesla MRI, Genetic: Apolipoprotein E genetic testParticipants will be screened to evaluate their eligibility. They will undergo clinical and cognitive assessments in addition to 32-channel EEG and 3 Tesla MRI at baseline (T0) and every year for 3 years. Furthermore, at baseline, a known genetic risk factors for AD will be explored (e., APOE gene profile). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- right-handed participants;
- monolingual native Italian speakers;
- age between 50-85 years old;
- normal or corrected-to-normal visual acuity;
- oral and written informed consent to study participation.
Key exclusion criteria (15 listed)
- secondary forms of cognitive impairment on the basis of historical data, neurologic examination, and cerebral neuroimaging findings;
- very rapid cognitive decline that occurs over weeks or months, typically indicative of prion disease, neoplasm or metabolic disorders;
- history of other systemic (including systemic neoplasms in the last 3 years and abnormal hepatorenal functions), neurologic (including epilepsy), psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations;
- alcohol and/or psychotropic drugs abuse;
- enrolment in clinical trials testing disease-modifying drugs for AD during study;
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 |
|---|---|---|
| ElectroencephalogramEEGs will be acquired to explore progressive alteration of EEG patterns throughout the neuropathology progression. | Diagnostic test | Clinical, EEG, brain MRI and genetic evaluations |
| 3 Tesla MRIMRI evaluations will be performed to investigate structural alterations and resting state functional MRI (RS-fMRI) connectivity in participants. Longitudinal measures of cortical/subcortical atrophy and RS-fMRI connectivity will be assessed and their relationship with EEG parameters will be explored. | Diagnostic test | Clinical, EEG, brain MRI and genetic evaluations |
| Apolipoprotein E genetic testAt baseline, a sample of blood will be collected to perform genetic analysis (APOE alleles) for all participants | Genetic | Clinical, EEG, brain MRI and genetic evaluations |
Primary outcome
Cortical source densities in resting-state EEG for mild cognitive impairment: Markers of differential diagnosis and dementia conversion prediction
Time frame: 36 months
Source densities in resting-state high-definition EEG in patients with mild cognitive impairment, measured as cortical markers for differential diagnosis of dementias and prediction of conversion to full-blown dementia
3 secondary outcomes
Accuracy of EEG markers in distinguishing Alzheimer's disease from other dementias measured by sensivity
Time frame: 36 months
Accuracy of EEG markers in distinguishing Alzheimer's disease from other dementias measured by specifity
Time frame: 36 months
Relationship between Alzheimer's disease and other dementias with APOE genetic variants
Time frame: 36 months
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 17 Feb 2025.
- BackgroundPascual-Marqui RD. Discrete, 3D distributed, linear imaging methods of electric neuronal activity. Part 1: exact, zero error localization. 2007.
- Background: PubMed 26199870Teipel SJ, Kurth J, Krause B, Grothe MJ; Alzheimer's Disease Neuroimaging Initiative. The relative importance of imaging markers for the prediction of Alzheimer's disease dementia in mild cognitive impairment - Beyond classical regression. Neuroimage Clin. 2015 May 21;8:583-93. doi: 10.1016/j.nicl.2015.05.006. eCollection 2015.
- BackgroundInternational AsD. World Alzheimer Report 2019: Attitudes to dementia. London: Alzheimer's Disease International, 2019
- Background: PubMed 34098525Cecchetti G, Agosta F, Basaia S, Cividini C, Cursi M, Santangelo R, Caso F, Minicucci F, Magnani G, Filippi M. Resting-state electroencephalographic biomarkers of Alzheimer's disease. Neuroimage Clin. 2021;31:102711. doi: 10.1016/j.nicl.2021.102711. Epub 2021 May 29.
- Background: PubMed 28592453McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7.
- Background: PubMed 21810890Rascovsky K, Hodges JR, Knopman D, Mendez MF, Kramer JH, Neuhaus J, van Swieten JC, Seelaar H, Dopper EG, Onyike CU, Hillis AE, Josephs KA, Boeve BF, Kertesz A, Seeley WW, Rankin KP, Johnson JK, Gorno-Tempini ML, Rosen H, Prioleau-Latham CE, Lee A, Kipps CM, Lillo P, Piguet O, Rohrer JD, Rossor MN, Warren JD, Fox NC, Galasko D, Salmon DP, Black SE, Mesulam M, Weintraub S, Dickerson BC, Diehl-Schmid J, Pasquier F, Deramecourt V, Lebert F, Pijnenburg Y, Chow TW, Manes F, Grafman J, Cappa SF, Freedman M, Grossman M, Miller BL. Sensitivity of revised diagnostic criteria for the behavioural variant of frontotemporal dementia. Brain. 2011 Sep;134(Pt 9):2456-77. doi: 10.1093/brain/awr179. Epub 2011 Aug 2.
- Background: PubMed 21514250McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
- Background: PubMed 21514249Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
- Background: PubMed 29653606Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
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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.
Massimo MF Filippi, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalogram, 3 Tesla MRI and Apolipoprotein E genetic test in people with Alzheimer Disease and Lewy Body Dementia (LBD), run by IRCCS San Raffaele 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 13 inclusion and 15 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: enrolling by invitation, as of the sponsor's last update on 17 Feb 2025. 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?
Cortical source densities in resting-state EEG for mild cognitive impairment: Markers of differential diagnosis and dementia conversion prediction (time frame: 36 months). 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 NCT06826157, which also lists 9 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 17 Feb 2025.