Neuroelectrical Biomarkers for Alzheimer's Disease Stages

Alzheimer Disease Clinical Trial

— ESTIMATE  

Official title:

NEw approacheS for The dIagnosis of AlzeiMer's diseAse Through neuroElectrical Changes in the Brain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880151
• Other study ID #: C12-71
• Secondary ID: 2013-A00344-41
• Status: Completed
• Phase: N/A
• Start date: July 12, 2013
• Est. completion date: January 2019

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• EEG
EEG recorded during a resting condition and during an episodic memory task condition

Locations

Country	Name	City	State
France	Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency band charactersitics of the electrophysiological brain response		Baseline