Sustainable Method for Alzheimer's Prediction

Catholic University of the Sacred Heart

Status: Completed

Conditions: Alzheimer Disease; Amnestic-Mild Cognitive Impairment

Treatments: Genetic: ApoE; Diagnostic Test: EEG

Study type: Observational

Funder types: Other

Identifiers

NCT03654911

ROSSINI_MSD_ID1764

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Exclusion criteria for AD will be:

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

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 design

150 participants in 1 patient group

aMCI subjects

Description:

EEG recording, ApoE testing

Treatment:

Diagnostic Test: EEG

Genetic: ApoE