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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
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

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

70 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
June 14, 2013
Last Updated
August 25, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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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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