Multiregional rtfMRI Neurofeedback for the Prevention of Alzheimer's Disease (NPAD)

NCT ID: NCT03173846

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-05

Study Completion Date

2019-12-31

Brief Summary

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This study aims to predict cognitive decline using a performance endophenotype of neuro-feedback based on functional magnetic resonance imaging in real time in a population at risk for Alzheimer's disease (AD).

Detailed Description

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In this research project, a longitudinal study in a healthy population that is under increased risk of developing AD will be performed. It is anticipated that some of the participating subjects will develop episodic memory decline within this longitudinal follow-up. The memory binding Test (MBT) and/or the Free and Cued Selective Reminding Test (FCSRT), the most accurate and reliable available episodic memory tests, are going to be performed by the subjects at multiple longitudinal data collection points. The project proposes to develop a real-time functional magnetic resonance imaging (rtfMRI) task, and to test whether the subjects' performance on the task can predict the apparition of cognitive decline. The impact of other relevant biomarkers by adding them to the model: age, gender, number of APOE-e4 alleles, cognitive scores, cerebrospinal fluid (CSF) biomarkers, amyloid Positron Emission Tomography (PET), lifestyle habits and clinical background will be studied.

Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult children of AD patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult men and women (aged 45-75) that have participated in the study 45-65/FPM2012.
* Persons that accept the study's test and procedures that are as follows: magnetic resonance imaging and neuropsychological tests.
* Signature of the study's informed consent form, accepting to not receive information with regards to any research results that are not clinically relevant.

Exclusion Criteria

* Any contraindication to MRI (e.g. pacemaker, claustrophobia, etc.)
* Any condition that according to the investigator's judgement could interfere with the proper execution of the study's procedures and/or its follow-up.
Minimum Eligible Age

45 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barcelonabeta Brain Research Center

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ALFA-NPAD/BBRC2016

Identifier Type: -

Identifier Source: org_study_id

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