Alzheimer DiseaseNPADNCT03173846
Multiregional rtfMRI Neurofeedback for the Prevention of Alzheimer's Disease (NPAD)
An observational study of Alzheimer Disease, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 45 to 79 years
- Conditions the study is for
- Alzheimer Disease
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 5 May 2017to 31 Dec 2019
- Phase
- Observational
- 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 45 to 79 years
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Alzheimer Disease
- Keywords
- neurofeedback, episodic memory, real-time functional MRI
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult children of AD patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognition
Predictive value of neurofeedback performance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start5 May 2017
- Primary completion31 Oct 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173846
- Sponsor's protocol ID
- ALFA-NPAD/BBRC2016
- Acronym
- NPAD
- Status last verified
- Jul 2020
- First submitted
- 29 May 2017
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiregional rtfMRI Neurofeedback for the Prevention of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03173846
- Acronym / sponsor ID
- NPAD / ALFA-NPAD/BBRC2016
- Conditions
- Alzheimer Disease
- Keywords
- neurofeedback, episodic memory, real-time functional MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall FoundationUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult children of AD patients | – | – |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in cognition
Time frame: 12 months
Predictive value of neurofeedback performance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
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 3 inclusion and 2 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 21 Jul 2020. 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 Spain. 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?
Change in cognition (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2020.