Neuroelectrical Biomarkers for Alzheimer's Disease Stages

NCT ID: NCT01880151

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-12
• Study Completion Date: 2019-01-31

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Prodromal AD

Presence of memory impairment Absence of impairment in activities of daily life EEG

Group Type: EXPERIMENTAL

EEG

Intervention Type: DEVICE

EEG recorded during a resting condition and during an episodic memory task condition

Mild AD dementia

Presence of memory impairment Presence of impairment in activities of daily life EEG

Group Type: EXPERIMENTAL

EEG

Intervention Type: DEVICE

EEG recorded during a resting condition and during an episodic memory task condition

Healthy control group

Absence of memory impairment Absence of impairment in activities of daily life Absence of known neurological conditions EEG

Group Type: EXPERIMENTAL

EEG

Intervention Type: DEVICE

EEG recorded during a resting condition and during an episodic memory task condition

Interventions

EEG

EEG recorded during a resting condition and during an episodic memory task condition

Intervention Type: DEVICE

Other Intervention Names

Electroencephalography; Electrical Geodesics Incorporated

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno Dubois, PhD,MD,Prof

Role: PRINCIPAL_INVESTIGATOR

Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital

Locations

Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital

Paris, , France

Countries

France

Other Identifiers

2013-A00344-41

Identifier Type: REGISTRY

Identifier Source: secondary_id

C12-71

Identifier Type: -

Identifier Source: org_study_id