Neuroelectrical Biomarkers for Alzheimer's Disease Stages

Not Applicable

Completed

• Conditions: Alzheimer Disease
• Interventions: Device: EEG

• Registration Number: NCT01880151
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

Recent diagnostic criteria for Alzheimer's disease (AD) recognize an extended spectrum of AD stages as part of the disease, including a preclinical stage. This underscores the importance of early prognosis of AD when it is still possible to influence the course of the disorder. The investigators propose a comprehensive project which will target the data-driven modeling of the disease development. This goal will be achieved by creating and validating a battery of new sensitive biomarkers for clinical evaluation and prediction of AD in individuals. The AD-related brain changes will be assessed by noninvasive functional EEG measured during an episodic memory task in subjects at different stages of AD, as well as in healthy controls. The novel functional biomarkers will be extracted using a rigorous multistage selection procedure involving advanced methods for feature extraction, as well as statistics and classification for optimal selection. The ESTIMATE project will serve as a first step in an extensive array of research procedures which will enable the early clinical identification of Alzheimer's disease in elderly individuals who could then take advantage of preventive pharmaceutical therapies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-18
• Study Start: 2013-07-12
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• Age: 70-85 years old
• Presence of memory impairment
• Completed educational level: middle school
• Visual and auditory acuity: normal or corrected-to-normal

Exclusion Criteria

• Monogenic AD
• Presence of a neurological disorder
• Stroke that has occurred in the last three months
• Prohibited medications
• Residence in skilled nursing facility
• Illiteracy, is unable to count or to read
• Claustrophobia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy control group	EEG	Absence of memory impairment Absence of impairment in activities of daily life Absence of known neurological conditions EEG
Mild AD dementia	EEG	Presence of memory impairment Presence of impairment in activities of daily life EEG
Prodromal AD	EEG	Presence of memory impairment Absence of impairment in activities of daily life EEG

Primary Outcome Measures

Name	Time	Method
Frequency band charactersitics of the electrophysiological brain response	Baseline

Trial Locations

Locations (1)

Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital; 🇫🇷 Paris, France