- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05624632
Cognitive Remote Assessment Using FLAME (CRA-FLAME)
We aim to use a multimodal approach comprising conventional neuropsychological cognitive tests, fluid and imaging biomarker data, to explore their association with the FLAME unsupervised cognitive computerized assessment. We believe that this would provide critical information to move forward the current research framework in the field.
Participants will be selected from BBRC-sponsored studies, such as the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA - FPM - 0311), the Beta-AARC study (β-AARC_BBRC2020) or the BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We aim to use a multimodal approach comprising conventional neuropsychological cognitive tests, fluid and imaging biomarker data, to explore their association with the FLAME unsupervised cognitive computerized assessment. We believe that this would provide critical information to move forward the current research framework in the field.
Participants will be selected from BBRC-sponsored studies, such as the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA - FPM - 0311), the Beta-AARC study (β-AARC_BBRC2020) or the BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018)
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08005
- Barcelonabeta Brain Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Participants must meet ALL the following criteria:
- To sign the study informed consent form approved by the corresponding authorities.
- Men and women that have participated/are participating in a BBRC-sponsored study.
To accept that:
- The results obtained in this study may be published in scientific journals and at BBRC's communication channels (e.g. web page)
- The data gathered may be used in combination with those gathered in other BBRC-sponsored studies in which they may (have) participate(d)
Exclusion Criteria:
1. Not having an ICT literacy enough to access and complete the online tests.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cognitively unimpaired
Cognitively unimpaired participants from BBRC-sponsored studies
|
Remote cognitive testing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FLAME global composite score
Time Frame: through study completion, an average of 3 years
|
calculated by combining information from two web-based online neuropsychological test batteries that are already integrated in a unique platform: the PROTECT Cognitive Tests System (PCTS) (Corbett et al., 2015) and the CogTrackTM (Wesnes et al., 2017)
|
through study completion, an average of 3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRA- FLAME/BBRC2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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