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Neuroelectrical Biomarkers for Alzheimer's Disease Stages (ESTIMATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880151
Recruitment Status : Completed
First Posted : June 18, 2013
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Device: EEG Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: NEw approacheS for The dIagnosis of AlzeiMer's diseAse Through neuroElectrical Changes in the Brain
Actual Study Start Date : July 12, 2013
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Frequency band charactersitics of the electrophysiological brain response [ Time Frame: Baseline ]

Eligibility Criteria
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Ages Eligible for Study:   70 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880151


Locations
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France
Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital
Paris, France, 75013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Bruno Dubois, PhD,MD,Prof Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital
More Information
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01880151    
Other Study ID Numbers: C12-71
2013-A00344-41 ( Registry Identifier: IDRCB )
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Alzheimer's disease
Dementia
Prodromal
 EEG
ERP
Biomarkers
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders