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CompletedNCT01880151ESTIMATEUpdated Aug 26, 2021

Neuroelectrical Biomarkers for Alzheimer's Disease Stages

An interventional study of EEG in Alzheimer Disease, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 1 site in France. Open to participants aged 70 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-26.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
70 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer Disease

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Keywords

  • Alzheimer's disease
  • Dementia
  • Prodromal
  • EEG
  • ERP
  • Biomarkers
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 87 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 375 studies on the registry; 82 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
87 participants (actual)

Study arms

  • Experimental
    Prodromal AD

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

    Device: EEG

  • Experimental
    Mild AD dementia

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

    Device: EEG

  • Experimental
    Healthy control group

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

    Device: EEG

Interventions

  • DeviceEEG

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

    Also known as: Electroencephalography, Electrical Geodesics Incorporated

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What researchers measure

Primary outcomes

  1. Frequency band charactersitics of the electrophysiological brain response

    Time frame: Baseline

07

Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01880151
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Jun 18, 2013
Start date
Jul 12, 2013
Primary completion
Jan 2019
Completion
Jan 2019
Last update
Aug 26, 2021

Study contacts

Bruno Dubois, PhD,MD,Prof
principal investigator · Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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