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

Multiregional rtfMRI Neurofeedback for the Prevention of Alzheimer's Disease

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).

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08005
    • Barcelonabeta Brain Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participating subjects are healthy adults (aged 45-75 at inclusion) already recruited within the ALFA study (http://clinicaltrials.gov/ct2/show/NCT01835717; Estudi 45-65 FPM/2012).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adult children of AD patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognition	Predictive value of neurofeedback performance	12 months

Collaborators and Investigators

• Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: neurofeedback; episodic memory; real-time functional MRI
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: ALFA-NPAD/BBRC2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No