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Completed

NCT Number: NCT03173846

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

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).

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Key information

Age range

45 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barcelonabeta Brain Research Center

Barcelona, 08005, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in cognition

    Time frame: 12 months

    Predictive value of neurofeedback performance

Sponsors and collaborators

Lead sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Other

Registry information

Official study title

Multiregional rtfMRI Neurofeedback for the Prevention of Alzheimer's Disease

Acronym: NPAD

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 2, 2017
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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