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Alzheimer DiseaseESTIMATENCT01880151

Neuroelectrical Biomarkers for Alzheimer's Disease Stages

A study testing EEG in people with Alzheimer Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
EEG
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteFrance
Study dates
12 Jul 2013to Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Paris, 75013

Other trials in France

About this study

Official title: 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.

Being tested
EEG
Keywords
Alzheimer's disease, Dementia, Prodromal, EEG, ERP, Biomarkers
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EEGDevice

    Also called Electroencephalography, Electrical Geodesics Incorporated

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

Study groups in NCT01880151
Study groupRoleWhat they receive
Prodromal ADExperimentalPresence of memory impairment Absence of impairment in activities of daily life EEG
Receives: Device: EEG
Mild AD dementiaExperimentalPresence of memory impairment Presence of impairment in activities of daily life EEG
Receives: Device: EEG
Healthy control groupExperimentalAbsence of memory impairment Absence of impairment in activities of daily life Absence of known neurological conditions EEG
Receives: Device: EEG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency band charactersitics of the electrophysiological brain response

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2013 (estimated)
  2. Study start12 Jul 2013
  3. Primary completionJan 2019
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01880151
Sponsor's protocol ID
C12-71
Other IDs
2013-A00344-41
Acronym
ESTIMATE
Status last verified
Aug 2021
First submitted
14 Jun 2013
Last updated
26 Aug 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing EEG in people with Alzheimer Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency band charactersitics of the electrophysiological brain response (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01880151.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.

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