NCT05624632

Brief 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)

Trial Health

75
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress86%
Dec 2022Dec 2026

First Submitted

Initial submission to the registry

November 8, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

November 8, 2022

Last Update Submit

May 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Cognitively unimpaired

Cognitively unimpaired participants from BBRC-sponsored studies

Other: Remote cognitive testing

Interventions

Remote cognitive testing

Cognitively unimpaired

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants are individuals that have participated/are participating in BBRC-sponsored studies.

You may qualify if:

  • 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)

You may not qualify if:

  • \. Not having an ICT literacy enough to access and complete the online tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BarcelonaBeta Brain Research Center

Barcelona, 08005, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

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

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 22, 2022

Study Start

December 1, 2022

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations