Neuroelectrical Biomarkers for Alzheimer's Disease Stages (ESTIMATE)

August 25, 2021 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 85 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Prodromal AD
Presence of memory impairment Absence of impairment in activities of daily life EEG
Device: EEG
EEG recorded during a resting condition and during an episodic memory task condition
Other Names:
  • Electroencephalography
  • Electrical Geodesics Incorporated
EXPERIMENTAL: Mild AD dementia
Presence of memory impairment Presence of impairment in activities of daily life EEG
Device: EEG
EEG recorded during a resting condition and during an episodic memory task condition
Other Names:
  • Electroencephalography
  • Electrical Geodesics Incorporated
EXPERIMENTAL: Healthy control group
Absence of memory impairment Absence of impairment in activities of daily life Absence of known neurological conditions EEG
Device: EEG
EEG recorded during a resting condition and during an episodic memory task condition
Other Names:
  • Electroencephalography
  • Electrical Geodesics Incorporated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency band charactersitics of the electrophysiological brain response
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Bruno Dubois, PhD,MD,Prof, Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 12, 2013

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

January 1, 2019

Study Registration Dates

First Submitted

June 14, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (ESTIMATE)

June 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C12-71
  • 2013-A00344-41 (REGISTRY: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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