Cognitive Remote Assessment Using FLAME (CRA-FLAME)

Cognitive Impairment Clinical Trial

Official title:

Cognitive Remote Assessment Using FLAME (CRA-FLAME)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05624632
• Other study ID #: CRA- FLAME/BBRC2022
• Status: Enrolling by invitation
• Start date: December 1, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: April 2024
• Source: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

Participants must meet ALL the following criteria:

1. To sign the study informed consent form approved by the corresponding authorities.

2. Men and women that have participated/are participating in a BBRC-sponsored study.

3. 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Other:
• Remote cognitive testing
Remote cognitive testing

Locations

Country	Name	City	State
Spain	BarcelonaBeta Brain Research Center	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FLAME global composite score	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