NCT03173846

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

May 29, 2017

Last Update Submit

July 20, 2020

Conditions

Alzheimer Disease

Keywords

neurofeedbackepisodic memoryreal-time functional MRI

Outcome Measures

Primary Outcomes (1)

  • Change in cognition

    Predictive value of neurofeedback performance

    12 months

Study Arms (1)

Adult children of AD patients

Eligibility Criteria

Age45 Years - 79 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barcelonabeta Brain Research Center

Barcelona, 08005, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 2, 2017

Study Start

May 5, 2017

Primary Completion

October 31, 2018

Study Completion

December 31, 2019

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)