Cognitive ChangeCODECNCT06330090
COgnitive Dynamics in Early Childhood
An observational study of Cognitive Change, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The goal of this accelerated longitudinal observational cohort study is to advance our understanding of cognitive variability in children aged 7 to 10 at first measurement. The CODEC study aims to integrate experience sampling methods, longitudinal designs, deep phenotyping cohorts, and state-of-the-art statistical… Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- How many people
- 600 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Nov 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 600 children will be recruited from schools and on individual bases to take part in the behavioural testing. A subgroup of 200 children will be further recruited to participate in the imaging part of the study at the Donders Institute.
Who may be able to join
- In order to be eligible to participate in the behavioural arm of this study, a subject must meet all of the following criteria:
- Between the ages of 7 and 10 years at the moment of the first assessment. In order to be eligible to participate in the imaging arm of this study, a subject must meet all of the following criteria:
- Between the ages of 8 and 10 years at the moment of the first assessment.
Who cannot join
- A potential subject will be excluded from participation in the study if the participant indicates not understanding the instructions of the behavioural tasks due to a language barrier. In the imaging arm of the study, a potential subject who meets any of the following criteria will further be excluded from participation in the imaging arm of the study:
- History of neurological or psychiatric illness.
- History of using psychotropic medications.
- Contraindications for MRI.
- Metal parts that cannot be removed, are present in or on upper body, e.g. plates, screws, aneurysm clips, metal splinters, piercings or medical plasters. (exception: dental fillings, crowns, a metal wire behind the teeth, tattoos and contraceptive coils).
- Body containing metal fragments, in particular in the eye, e.g., caused by injuries when working with metal.
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- History of brain surgery.
- Active implant(s) (e.g. pacemaker, neurostimulator, insulin pump, ossicle prosthesis)
- Using a medical plaster that cannot or may not be taken off (e.g. nicotine plaster)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ilse Coolen contact
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc Department of Cognitive Neuroscience
Nijmegen, 6525 EN
About this study
Official title: Cognitive Dynamics in Early Childhood
The goal of this accelerated longitudinal observational cohort study is to advance our understanding of cognitive variability in children aged 7 to 10 at first measurement. The CODEC study aims to integrate experience sampling methods, longitudinal designs, deep phenotyping cohorts, and state-of-the-art statistical methodologies to investigate three core questions:
- How does cognitive variability differ between individuals?
- What are the neural, psychological, and environmental mechanisms that underlie cognitive variability?
- What are the long-term consequences and outcomes associated with differences in cognitive variability?
- Conditions
- Cognitive Change
- Keywords
- cognition
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 |
|---|---|---|
| Design | Behavioural or behavioural with imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction times from the vocabulary cognitive task
RT from accurate responses from the vocabulary task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Measured: Through study completion, an average of 3 years
Reaction times from the exploration cognitive task
RT from accurate responses from the exploration task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Measured: Through study completion, an average of 3 years
Reaction times from the Working Memory cognitive task
RT from accurate responses from the WM task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Measured: Through study completion, an average of 3 years
Reaction times from the speed cognitive task
RT from accurate responses from the speed raction time task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Measured: Through study completion, an average of 3 years
Reaction times from the fluid reasoning cognitive task
RT from accurate responses from the fluid reasoning task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Measured: Through study completion, an average of 3 years
Mood score on smiley slider
The current mood of the participant on a smiley slider from 0-100 during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Measured: Through study completion, an average of 3 years
Sleep score on smiley slider
The current level of tiredness of the participant on a smiley slider from 0-100 during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Measured: Through study completion, an average of 3 years
MP-RAGE MRI sequence baseline
Structural MP-RAGE MRI scan at baseline measurement
Measured: an average of 1 year
Functional MRI sequence of low time constraint reasoning task at baseline
Functional MRI scan at baseline measurement when participants perform fluid reasoning task with low time contraint.
Measured: an average of 1 year
gaze direction during reasoning task at baseline
gaze direction recording through eye-tracking at baseline measurement when participants perform fluid reasoning task.
Measured: an average of 1 year
pupil dilation during reasoning task at baseline
pupil dilation recording through eye-tracking at baseline measurement when participants perform fluid reasoning task.
Measured: an average of 1 year
Naturalistic viewing fMRI at baseline
Naturalistic viewing fMRI at baseline measurement.
Measured: an average of 1 year
Naturalistic viewing fMRI at follow-up
Naturalistic viewing fMRI at follow-up measurement.
Measured: two years after baseline
Functional MRI sequence of high time constraint reasoning task at follow-up
Functional MRI scan at follow-up measurement when participants perform fluid reasoning task with high time contraint.
Measured: two years after baseline
gaze direction during reasoning task at baseline at follow-up
gaze direction recording through eye-tracking at follow-up measurement when participants perform fluid reasoning task.
Measured: two years after baseline
pupil dilation during reasoning task at baseline at follow-up
pupil dilation recording through eye-tracking at follow-up measurement when participants perform fluid reasoning task.
Measured: two years after baseline
Functional MRI sequence of low time constraint reasoning task at follow-up
Functional MRI scan at follow-up measurement when participants perform fluid reasoning task with low time contraint.
Measured: two years after baseline
Sparse MP2-Rage MRI sequence baseline
Structural Sparse MP2-Rage MRI scan at baseline measurement
Measured: an average of 1 year
Diffusion weighted imaging MRI sequence baseline
Diffusion weighted imaging MRI scan at baseline measurement
Measured: an average of 1 year
MP-RAGE MRI sequence follow up
Structural MP-RAGE MRI scan at follow up measurement
Measured: two years after baseline
Sparse MP2-Rage MRI sequence follow up
Structural Sparse MP2-Rage MRI scan at follow up measurement
Measured: two years after baseline
Diffusion weighted imaging MRI sequence follow up
Diffusion weighted imaging MRI scan at follow up measurement
Measured: two years after baseline
Total score for Highly Sensitive Child scale at baseline
Participant reported 12-item Dutch version of the HSC scale measured at baseline. Each item is scored on a scale from 1-strongly disagree to 7-strongly agree
Measured: an average of 1 year
Total score for Strengths and difficulties questionnaire at baseline
Parent reported 25-item Dutch version of the SDQ measured at baseline. Each item is scored (0-not at all/only a little, 1-quite a lot, 2-a great deal)
Measured: an average of 1 year
Total score for BRIEF-2 questionnaire at baseline
Parent reported Dutch version of the Behaviour Rating Inventory of Executive Function 2 measured at baseline.
Measured: an average of 1 year
Total score for BRIEF-2 questionnaire at follow-up
Parent reported Dutch version of the Behaviour Rating Inventory of Executive Function 2 measured at follow-up.
Measured: two years after baseline
Total score for Strengths and difficulties questionnaire at follow-up
Parent reported 25-item Dutch version of the SDQ measured at follow-up. Each item is scored (0-not at all/only a little, 1-quite a lot, 2-a great deal)
Measured: two years after baseline
Total score for Mind Excessively Wandering Scale scale at baseline
Participant reported 12-item Dutch version of the MEWS scale measured at baseline. Each item is scored on a scale from 0 (not at all or rarely) to 3 (nearly all of the time or constantly)
Measured: an average of 1 year
Originality score for the Alternative Uses Tasks at baseline
Originality score of responses on an alternative uses task at baseline.
Measured: an average of 1 year
Originality score for the Alternative Uses Tasks at follow-up
Originality score of responses on an alternative uses task at follow-up.
Measured: two years after baseline
Total score for Parent-reported Mind Excessively Wandering Scale scale at baseline
Parent reported 12-item Dutch version of the MEWS scale measured at baseline. Each item is scored on a scale from 0 (not at all or rarely) to 3 (nearly all of the time or constantly)
Measured: an average of 1 year
Total score for Parent-reported Socio-demographic questionnaire at baseline
Parent reported socio-demograpic questionnaire at baseline. Total score on SES related questions (highest level of educationm professional situation) will be measured.
Measured: an average of 1 year
Total score for Parent-reported Socio-demographic questionnaire at follow-up
Parent reported socio-demograpic questionnaire at baseline. Total score on SES related questions (highest level of education, professional situation) will be measured.
Measured: two years after baseline
Total score for Mind Excessively Wandering Scale scale at follow-up
Participant reported 12-item Dutch version of the MEWS scale measured at follow-up. Each item is scored on a scale from 0 (not at all or rarely) to 3 (nearly all of the time or constantly)
Measured: two years after baseline
Total score for Parent-reported Mind Excessively Wandering Scale scale at follow-up
Parent reported 12-item Dutch version of the MEWS scale measured at follow-up. Each item is scored on a scale from 0 (not at all or rarely) to 3 (nearly all of the time or constantly)
Measured: two years after baseline
Total score for Highly Sensitive Child scale at follow-up
Participant-reported 12-item Dutch version of the HSC scale measured at follow-up. Each item is scored on a scale from 1-strongly disagree to 7-strongly agree
Measured: two years after baseline
Secondary outcomes (6)
motivation rating for cognitive tasks
Rating from least to most fun cognitive task once a year after completing the cognitie battery 10 times in the burst week
Measured: Through study completion, an average of 3 years
Decibel of background noise during cognitive testing
DB recording of background noise when performing the cognitive tasks at the start of the testing
Measured: Through study completion, an average of 3 years
Academic school result baseline
cito-scores, academic results on national test obtained through schools at baseline
Measured: an average of 1 year
Academic school result follow-up
cito-scores, academic results on national test obtained through schools at follow-up
Measured: two years after baseline
Parent reaction times on cognitive battery at baseline
Parents performed RT on accurate responses in measures on the complete cognitive battery (vocabulary, reasoning, exploration, working memory and speed) at baseline
Measured: an average of 1 year
Parent reaction times on cognitive battery at follow-up
Parents performed RT on accurate responses in measures on the complete cognitive battery (vocabulary, reasoning, exploration, working memory and speed) at follow-up
Measured: two years after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start18 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330090
- Sponsor's protocol ID
- NL84688.091.23
- Other IDs
- 101040534
- Acronym
- CODEC
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coolen IEJI, van Langen J, Hofman S, van Aagten FE, Schaaf JV, Michel L, Aristodemou M, Judd N, van Hout ATB, Meeussen E, Kievit RA. Protocol and preregistration for the CODEC project: measuring, modelling and mechanistically understanding the nature of cognitive variability in early childhood. BMC Psychol. 2024 Jul 26;12(1):407. doi: 10.1186/s40359-024-01904-5.
PubMed 39060934
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Dynamics in Early Childhood
- ClinicalTrials.gov ID
- NCT06330090
- Acronym / sponsor ID
- CODEC / NL84688.091.23
- Conditions
- Cognitive Change
- Keywords
- cognition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Mar 2024 (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.
The goal of this accelerated longitudinal observational cohort study is to advance our understanding of cognitive variability in children aged 7 to 10 at first measurement. The CODEC study aims to integrate experience sampling methods, longitudinal designs, deep phenotyping cohorts, and state-of-the-art statistical methodologies to investigate three core questions:
- How does cognitive variability differ between individuals?
- What are the neural, psychological, and environmental mechanisms that underlie cognitive variability?
- What are the long-term consequences and outcomes associated with differences in cognitive variability?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Design | – | –Behavioural or behavioural with imaging |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 600 children will be recruited from schools and on individual bases to take part in the behavioural testing. A subgroup of 200 children will be further recruited to participate in the imaging part of the study at the Donders Institute.
Key inclusion criteria (3 listed)
- In order to be eligible to participate in the behavioural arm of this study, a subject must meet all of the following criteria:
Key exclusion criteria (9 listed)
- A potential subject will be excluded from participation in the study if the participant indicates not understanding the instructions of the behavioural tasks due to a language barrier. In the imaging arm of the study, a potential subject who meets any of the following criteria will further be excluded from participation in the imaging arm of the study:
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
Reaction times from the vocabulary cognitive task
Time frame: Through study completion, an average of 3 years
RT from accurate responses from the vocabulary task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Reaction times from the exploration cognitive task
Time frame: Through study completion, an average of 3 years
RT from accurate responses from the exploration task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Reaction times from the Working Memory cognitive task
Time frame: Through study completion, an average of 3 years
RT from accurate responses from the WM task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Reaction times from the speed cognitive task
Time frame: Through study completion, an average of 3 years
RT from accurate responses from the speed raction time task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Reaction times from the fluid reasoning cognitive task
Time frame: Through study completion, an average of 3 years
RT from accurate responses from the fluid reasoning task in the cognitive battery during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Mood score on smiley slider
Time frame: Through study completion, an average of 3 years
The current mood of the participant on a smiley slider from 0-100 during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
Sleep score on smiley slider
Time frame: Through study completion, an average of 3 years
The current level of tiredness of the participant on a smiley slider from 0-100 during burst assessment (3x a day, 5x a week) and up to 2 additional occasions per year.
MP-RAGE MRI sequence baseline
Time frame: an average of 1 year
Structural MP-RAGE MRI scan at baseline measurement
Functional MRI sequence of low time constraint reasoning task at baseline
Time frame: an average of 1 year
Functional MRI scan at baseline measurement when participants perform fluid reasoning task with low time contraint.
gaze direction during reasoning task at baseline
Time frame: an average of 1 year
gaze direction recording through eye-tracking at baseline measurement when participants perform fluid reasoning task.
pupil dilation during reasoning task at baseline
Time frame: an average of 1 year
pupil dilation recording through eye-tracking at baseline measurement when participants perform fluid reasoning task.
Naturalistic viewing fMRI at baseline
Time frame: an average of 1 year
Naturalistic viewing fMRI at baseline measurement.
Naturalistic viewing fMRI at follow-up
Time frame: two years after baseline
Naturalistic viewing fMRI at follow-up measurement.
Functional MRI sequence of high time constraint reasoning task at follow-up
Time frame: two years after baseline
Functional MRI scan at follow-up measurement when participants perform fluid reasoning task with high time contraint.
gaze direction during reasoning task at baseline at follow-up
Time frame: two years after baseline
gaze direction recording through eye-tracking at follow-up measurement when participants perform fluid reasoning task.
pupil dilation during reasoning task at baseline at follow-up
Time frame: two years after baseline
pupil dilation recording through eye-tracking at follow-up measurement when participants perform fluid reasoning task.
Functional MRI sequence of low time constraint reasoning task at follow-up
Time frame: two years after baseline
Functional MRI scan at follow-up measurement when participants perform fluid reasoning task with low time contraint.
Sparse MP2-Rage MRI sequence baseline
Time frame: an average of 1 year
Structural Sparse MP2-Rage MRI scan at baseline measurement
Diffusion weighted imaging MRI sequence baseline
Time frame: an average of 1 year
Diffusion weighted imaging MRI scan at baseline measurement
MP-RAGE MRI sequence follow up
Time frame: two years after baseline
Structural MP-RAGE MRI scan at follow up measurement
Sparse MP2-Rage MRI sequence follow up
Time frame: two years after baseline
Structural Sparse MP2-Rage MRI scan at follow up measurement
Diffusion weighted imaging MRI sequence follow up
Time frame: two years after baseline
Diffusion weighted imaging MRI scan at follow up measurement
Total score for Highly Sensitive Child scale at baseline
Time frame: an average of 1 year
Participant reported 12-item Dutch version of the HSC scale measured at baseline. Each item is scored on a scale from 1-strongly disagree to 7-strongly agree
Total score for Strengths and difficulties questionnaire at baseline
Time frame: an average of 1 year
Parent reported 25-item Dutch version of the SDQ measured at baseline. Each item is scored (0-not at all/only a little, 1-quite a lot, 2-a great deal)
Total score for BRIEF-2 questionnaire at baseline
Time frame: an average of 1 year
Parent reported Dutch version of the Behaviour Rating Inventory of Executive Function 2 measured at baseline.
Total score for BRIEF-2 questionnaire at follow-up
Time frame: two years after baseline
Parent reported Dutch version of the Behaviour Rating Inventory of Executive Function 2 measured at follow-up.
Total score for Strengths and difficulties questionnaire at follow-up
Time frame: two years after baseline
Parent reported 25-item Dutch version of the SDQ measured at follow-up. Each item is scored (0-not at all/only a little, 1-quite a lot, 2-a great deal)
Total score for Mind Excessively Wandering Scale scale at baseline
Time frame: an average of 1 year
Participant reported 12-item Dutch version of the MEWS scale measured at baseline. Each item is scored on a scale from 0 (not at all or rarely) to 3 (nearly all of the time or constantly)
Originality score for the Alternative Uses Tasks at baseline
Time frame: an average of 1 year
Originality score of responses on an alternative uses task at baseline.
Originality score for the Alternative Uses Tasks at follow-up
Time frame: two years after baseline
Originality score of responses on an alternative uses task at follow-up.
Total score for Parent-reported Mind Excessively Wandering Scale scale at baseline
Time frame: an average of 1 year
Parent reported 12-item Dutch version of the MEWS scale measured at baseline. Each item is scored on a scale from 0 (not at all or rarely) to 3 (nearly all of the time or constantly)
Total score for Parent-reported Socio-demographic questionnaire at baseline
Time frame: an average of 1 year
Parent reported socio-demograpic questionnaire at baseline. Total score on SES related questions (highest level of educationm professional situation) will be measured.
Total score for Parent-reported Socio-demographic questionnaire at follow-up
Time frame: two years after baseline
Parent reported socio-demograpic questionnaire at baseline. Total score on SES related questions (highest level of education, professional situation) will be measured.
Total score for Mind Excessively Wandering Scale scale at follow-up
Time frame: two years after baseline
Participant reported 12-item Dutch version of the MEWS scale measured at follow-up. Each item is scored on a scale from 0 (not at all or rarely) to 3 (nearly all of the time or constantly)
Total score for Parent-reported Mind Excessively Wandering Scale scale at follow-up
Time frame: two years after baseline
Parent reported 12-item Dutch version of the MEWS scale measured at follow-up. Each item is scored on a scale from 0 (not at all or rarely) to 3 (nearly all of the time or constantly)
Total score for Highly Sensitive Child scale at follow-up
Time frame: two years after baseline
Participant-reported 12-item Dutch version of the HSC scale measured at follow-up. Each item is scored on a scale from 1-strongly disagree to 7-strongly agree
6 secondary outcomes
motivation rating for cognitive tasks
Time frame: Through study completion, an average of 3 years
Decibel of background noise during cognitive testing
Time frame: Through study completion, an average of 3 years
Academic school result baseline
Time frame: an average of 1 year
Academic school result follow-up
Time frame: two years after baseline
Parent reaction times on cognitive battery at baseline
Time frame: an average of 1 year
Parent reaction times on cognitive battery at follow-up
Time frame: two years after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 39060934Coolen IEJI, van Langen J, Hofman S, van Aagten FE, Schaaf JV, Michel L, Aristodemou M, Judd N, van Hout ATB, Meeussen E, Kievit RA. Protocol and preregistration for the CODEC project: measuring, modelling and mechanistically understanding the nature of cognitive variability in early childhood. BMC Psychol. 2024 Jul 26;12(1):407. doi: 10.1186/s40359-024-01904-5.
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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.
Ilse Coolen contact
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 Cognitive Change, run by Radboud University Medical Center at 1 site in Netherlands.
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 9 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: looking for participants now, as of the sponsor's last update on 11 Apr 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rogier Kievit (+31 (0) 24 361 42 24, rogier.kievit@donders.ru.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction times from the vocabulary cognitive task (time frame: Through study completion, an average of 3 years). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06330090, which also lists 1 linked publication.
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 11 Apr 2025.