Sustainable Method for Alzheimer's Prediction

NCT ID: NCT03654911

Last Updated: 2020-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-11

Study Completion Date

2020-01-31

Brief Summary

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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

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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

Conditions

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Alzheimer Disease Amnestic-Mild Cognitive Impairment

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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aMCI subjects

EEG recording, ApoE testing

EEG

Intervention Type DIAGNOSTIC_TEST

EEG

ApoE

Intervention Type GENETIC

ApoE

Interventions

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EEG

EEG

Intervention Type DIAGNOSTIC_TEST

ApoE

ApoE

Intervention Type GENETIC

Eligibility Criteria

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Exclusion Criteria

* frontotemporal dementia;
* behavioural variant of frontotemporal dementia;
* vascular dementia;
* extra-pyramidal syndromes;
* reversible dementias (including pseudodementia of depression);
* Lewy body dementia.


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Paolo Maria Rossini

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione Policlinico A.Gemelli IRCCS, Università Cattolica del Sacro Cuore

Rome, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 30014515 (View on PubMed)

Other Identifiers

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ROSSINI_MSD_ID1764

Identifier Type: -

Identifier Source: org_study_id

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