NCT01880151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
24 days until next milestone

Study Start

First participant enrolled

July 12, 2013

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

5.5 years

First QC Date

June 14, 2013

Last Update Submit

August 25, 2021

Conditions

Alzheimer Disease

Keywords

Alzheimer's diseaseDementiaProdromalEEGERPBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Frequency band charactersitics of the electrophysiological brain response

    Baseline

Study Arms (3)

Prodromal AD

EXPERIMENTAL

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

Device: EEG

Mild AD dementia

EXPERIMENTAL

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

Device: EEG

Healthy control group

EXPERIMENTAL

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

Device: EEG

Interventions

EEGDEVICE

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

Also known as: Electroencephalography, Electrical Geodesics Incorporated
Healthy control groupMild AD dementiaProdromal AD

Eligibility Criteria

Age70 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age: 70-85 years old
  • Presence of memory impairment
  • Completed educational level: middle school
  • Visual and auditory acuity: normal or corrected-to-normal

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Bruno Dubois, PhD,MD,Prof

    Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 18, 2013

Study Start

July 12, 2013

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations

FR(1)