Neuroelectrical Biomarkers for Alzheimer's Disease Stages (ESTIMATE)
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EEG
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Alzheimer's disease, Dementia, Prodromal, EEG, ERP, Biomarkers
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
Sites / Locations
- Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Prodromal AD
Mild AD dementia
Healthy control group
Arm Description
Presence of memory impairment Absence of impairment in activities of daily life EEG
Presence of memory impairment Presence of impairment in activities of daily life EEG
Absence of memory impairment Absence of impairment in activities of daily life Absence of known neurological conditions EEG
Outcomes
Primary Outcome Measures
Frequency band charactersitics of the electrophysiological brain response
Secondary Outcome Measures
Full Information
NCT ID
NCT01880151
First Posted
June 14, 2013
Last Updated
August 25, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT01880151
Brief Title
Neuroelectrical Biomarkers for Alzheimer's Disease Stages
Acronym
ESTIMATE
Official Title
NEw approacheS for The dIagnosis of AlzeiMer's diseAse Through neuroElectrical Changes in the Brain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 12, 2013 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's disease, Dementia, Prodromal, EEG, ERP, Biomarkers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prodromal AD
Arm Type
Experimental
Arm Description
Presence of memory impairment Absence of impairment in activities of daily life EEG
Arm Title
Mild AD dementia
Arm Type
Experimental
Arm Description
Presence of memory impairment Presence of impairment in activities of daily life EEG
Arm Title
Healthy control group
Arm Type
Experimental
Arm Description
Absence of memory impairment Absence of impairment in activities of daily life Absence of known neurological conditions EEG
Intervention Type
Device
Intervention Name(s)
EEG
Other Intervention Name(s)
Electroencephalography, Electrical Geodesics Incorporated
Intervention Description
EEG recorded during a resting condition and during an episodic memory task condition
Primary Outcome Measure Information:
Title
Frequency band charactersitics of the electrophysiological brain response
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Dubois, PhD,MD,Prof
Organizational Affiliation
Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Learn more about this trial
Neuroelectrical Biomarkers for Alzheimer's Disease Stages
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