Alzheimer DiseaseNCT03654911
Sustainable Method for Alzheimer's Prediction
An observational study of Alzheimer Disease and Amnestic-Mild Cognitive Impairment, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
This is an observational study with the aim of validating, in a consistent population sample, with appropriate follow-up, whether EEG connectivity analysis combined with the neuropsychological evaluation and ApoE genotype testing in aMCI could be of help in early identification of converted aMCI as a first-line… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Amnestic-Mild Cognitive Impairment
- What is being tested?
- EEG and ApoE
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 11 Apr 2018to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants 150 aMCI will be recruited (including 90 already available EEG and clinical data recordings) in order to obtain two homogeneous sub-groups according to the clinical follow-up, classifying them as converted to AD or stable aMCI after a 12 to 24 months period from the time of baseline EEG recording.
Who may be able to join
None listed.
Who cannot join
- frontotemporal dementia;
- behavioural variant of frontotemporal dementia;
- vascular dementia;
- extra-pyramidal syndromes;
- reversible dementias (including pseudodementia of depression);
- Lewy body dementia.
Show all 13Show fewer
- The exclusion criteria for aMCI will be:
- mild AD, as diagnosed by standard protocols including National Institute on Aging-Alzheimer's Association workgroups (McKhann et al. 2011);
- evidence (including magnetic resonance imaging -MRI procedures) of concomitant dementia such as frontotemporal, vascular and reversible dementias (including pseudo-depressive dementia), marked fluctuations in cognitive performance compatible with Lewy body dementia and/or features of mixed dementias;
- evidence of concomitant extrapyramidal symptoms;
- clinical and indirect evidence of depression as revealed by the Geriatric Depression Scale GDS (Yesavage et al. 1982); scores lower than 14 (no depression);
- other psychiatric diseases, epilepsy, drug addiction, alcohol dependence, use of neuro/psychoactive drugs including acetylcholinesterase inhibitors;
- current or previous uncontrolled or complicated systemic diseases (including diabetes mellitus) or traumatic brain injuries.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico A.Gemelli IRCCS, Università Cattolica del Sacro Cuore
Rome
About this study
Official title: Sustainable Method for Alzheimer's Prediction in Mild Cognitive Impairment: EEG Connectivity and Graph Theory Combined With ApoE Testing.
This is an observational study with the aim of validating, in a consistent population sample, with appropriate follow-up, whether EEG connectivity analysis combined with the neuropsychological evaluation and ApoE genotype testing in aMCI could be of help in early identification of converted aMCI as a first-line screening method in order to intercept early those subjects with a high risk for rapid progression to AD.
Read the detailed description
Primary aim of the present project is to investigate the dynamic connectivity among brain centers by using a mathematical (Small World) approach to the analysis of EEG-related neural networks. The aim is to provide reliable discrimination of amnesic-Mild Cognitive Impairment (a MCI) subjects who, on individual basis, will rapidly convert to Alzheimer Disease (AD) after a relatively brief follow-up. Moreover, keeping in mind that the epsilon-4 allele of the ApoE gene is a genetically determined risk factor for pathogenesis of late-onset AD, a secondary endpoint is introduced to investigate whether the EEG connectivity markers together with a genetically determined risk of dementia as represented by ApoE testing can reach higher sensitivity/specificity for early discrimination of MCI converting to AD
- Being tested
- EEG, ApoE
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDiagnostic test
EEG
ApoEGenetic
ApoE
| Study group | Role | What they receive |
|---|---|---|
| aMCI subjects | EEG recording, ApoE testing Receives: Diagnostic Test: EEG; Genetic: ApoE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers: EEG
EEG recording will be performed at rest, with closed eyes from routine electrode scalp positions according to the International 10-20 system. Functional connectivity analysis will be performed using eLORETA evaluating intracortical Lagged Linear Coherence. Weighted and undirected networks will be built from the above measure. Small World parameter is a dimentionless number that will be assessed as Biomarker of brain connectivity networks, since it measures the balance between local connectedness and the global integration of a network, representing brain network organization. Small world index will be computed in the seven EEG frequency bands delta (2-4 Hz), theta (4-8 Hz), alpha 1 (8-10.5 Hz), alpha 2 (10.5-13 Hz), beta 1 (13-20 Hz), beta 2 (20-30 Hz) and gamma (30-45 Hz) (Vecchio et al., 2018 doi: 10.1002/ana.25289)
Measured: 2 years
Biomarker: ApoE4
It will be evaluated the allele of the Apo-E gene as biomarker for the pathogenesis of late-onset and sporadic AD. The Apo-E test provides a dimentionless value represented by the type of the allele (ε2, ε3,ε4).
Measured: 2 years
Secondary outcomes (1)
Biomarker: Accuracy of digital classifier
Secondary endpoint will be to investigate whether EEG connectivity markers (small world ) along with genetically determined risk-indicators for dementia, as represented by Apo-E testing can reach a greater sensitivity, specificity and accuracy for a digital classifier (i.e. an algorithm that solve the problem of identifying to which of a set of categories a new observation belongs) able to predict the MCI conversion to AD. The accuracy value is dimentionless number represented by a percentual value and it is the biomarker for the ability of the classifier for the early identification of AD (Vecchio F. et al., 2018 doi: 10.1002/ana.25289)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start11 Apr 2018
- Primary completion28 Jun 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer 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 only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Maria Rossini, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654911
- Sponsor's protocol ID
- ROSSINI_MSD_ID1764
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vecchio F, Miraglia F, Iberite F, Lacidogna G, Guglielmi V, Marra C, Pasqualetti P, Tiziano FD, Rossini PM. Sustainable method for Alzheimer dementia prediction in mild cognitive impairment: Electroencephalographic connectivity and graph theory combined with apolipoprotein E. Ann Neurol. 2018 Aug;84(2):302-314. doi: 10.1002/ana.25289. Epub 2018 Aug 25.
PubMed 30014515
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Method for Alzheimer's Prediction in Mild Cognitive Impairment: EEG Connectivity and Graph Theory Combined With ApoE Testing.
- ClinicalTrials.gov ID
- NCT03654911
- Acronym / sponsor ID
- ROSSINI_MSD_ID1764
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study with the aim of validating, in a consistent population sample, with appropriate follow-up, whether EEG connectivity analysis combined with the neuropsychological evaluation and ApoE genotype testing in aMCI could be of help in early identification of converted aMCI as a first-line screening method in order to intercept early those subjects with a high risk for rapid progression to AD.
Detailed description
Primary aim of the present project is to investigate the dynamic connectivity among brain centers by using a mathematical (Small World) approach to the analysis of EEG-related neural networks. The aim is to provide reliable discrimination of amnesic-Mild Cognitive Impairment (a MCI) subjects who, on individual basis, will rapidly convert to Alzheimer Disease (AD) after a relatively brief follow-up. Moreover, keeping in mind that the epsilon-4 allele of the ApoE gene is a genetically determined risk factor for pathogenesis of late-onset AD, a secondary endpoint is introduced to investigate whether the EEG connectivity markers together with a genetically determined risk of dementia as represented by ApoE testing can reach higher sensitivity/specificity for early discrimination of MCI converting to AD
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aMCI subjects | – | Diagnostic Test: EEG, Genetic: ApoEEEG recording, ApoE testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants 150 aMCI will be recruited (including 90 already available EEG and clinical data recordings) in order to obtain two homogeneous sub-groups according to the clinical follow-up, classifying them as converted to AD or stable aMCI after a 12 to 24 months period from the time of baseline EEG recording.
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- frontotemporal dementia;
- behavioural variant of frontotemporal dementia;
- vascular dementia;
- extra-pyramidal syndromes;
- reversible dementias (including pseudodementia of depression);
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 |
|---|---|---|
| EEGEEG | Diagnostic test | aMCI subjects |
| ApoEApoE | Genetic | aMCI subjects |
Primary outcome
Biomarkers: EEG
Time frame: 2 years
EEG recording will be performed at rest, with closed eyes from routine electrode scalp positions according to the International 10-20 system. Functional connectivity analysis will be performed using eLORETA evaluating intracortical Lagged Linear Coherence. Weighted and undirected networks will be built from the above measure. Small World parameter is a dimentionless number that will be assessed as Biomarker of brain connectivity networks, since it measures the balance between local connectedness and the global integration of a network, representing brain network organization. Small world index will be computed in the seven EEG frequency bands delta (2-4 Hz), theta (4-8 Hz), alpha 1 (8-10.5 Hz), alpha 2 (10.5-13 Hz), beta 1 (13-20 Hz), beta 2 (20-30 Hz) and gamma (30-45 Hz) (Vecchio et al., 2018 doi: 10.1002/ana.25289)
Biomarker: ApoE4
Time frame: 2 years
It will be evaluated the allele of the Apo-E gene as biomarker for the pathogenesis of late-onset and sporadic AD. The Apo-E test provides a dimentionless value represented by the type of the allele (ε2, ε3,ε4).
1 secondary outcome
Biomarker: Accuracy of digital classifier
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Background: PubMed 30014515Vecchio F, Miraglia F, Iberite F, Lacidogna G, Guglielmi V, Marra C, Pasqualetti P, Tiziano FD, Rossini PM. Sustainable method for Alzheimer dementia prediction in mild cognitive impairment: Electroencephalographic connectivity and graph theory combined with apolipoprotein E. Ann Neurol. 2018 Aug;84(2):302-314. doi: 10.1002/ana.25289. Epub 2018 Aug 25.
- Individual participant dataSharing planned: No
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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 Alzheimer Disease and Amnestic-Mild Cognitive Impairment, run by Catholic University of the Sacred Heart 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 0 inclusion and 13 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: finished, as of the sponsor's last update on 22 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biomarkers: EEG (time frame: 2 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 NCT03654911, which also lists 1 linked publication.
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 22 Jul 2020.