Sustainable Method for Alzheimer's Prediction

NCT03654911 | Completed

• 1 other identifier: ROSSINI_MSD_ID1764
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 screening method in order to intercept early those subjects with a high risk for rapid progression to AD.

Conditions

Alzheimer Disease; Amnestic-Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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)

  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).

  2 years

Secondary Outcomes (1)

• Biomarker: Accuracy of digital classifier

  2 years

Study Arms (1)

aMCI subjects

EEG recording, ApoE testing

Diagnostic Test: EEG; Genetic: ApoE

Interventions

EEG DIAGNOSTIC_TEST

EEG

aMCI subjects

ApoE GENETIC

ApoE

aMCI subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

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

Rome, Italy

Location

Related Publications (1)

• 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.

  PMID: 30014515 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Electroencephalography; Apolipoproteins E

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Apolipoproteins; Lipoproteins; Lipids; Apoproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 31, 2018
• Study Start: April 11, 2018
• Primary Completion: June 28, 2019
• Study Completion: January 31, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)