Cognitive ChangeNCT05396586
Understanding Individual Differences in Working Memory Training and Transfer in Older Adults
A study testing N-back, Span and Multisensory in people with Cognitive Change, run by Northeastern University at 2 sites in United States.
Trial summary
The present study investigates how individual differences in cognitive processing contribute to the efficacy of working memory training programs in an older adult population. In a randomized crossover design, different types of working memory training interventions will be evaluated within the same participants. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- N-back, Span and Multisensory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Mar 2022to 5 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-85 years of age
- Able to understand and speak English and follow study procedures
- Does not have a psychological or neurological condition that would prevent being able to give consent to participate
- Not currently involved in any other cognitive or memory training studies
Who cannot join
- Formal diagnosis of dementia or other neurological disease, including Mild cognitive impairment.
- A final total score below 17 on Montreal Cognitive Assessment - Blind (telephone) version.
- Score of 10 or more on the Generalized Anxiety Questionnaire (GAD7; Spitzer et al., 2006, Archives of Internal Medicine), indicating presence of moderate or severe anxiety
- Score of 9 or more on Geriatric depression scale (GDS15; Yesavage et al., 1982) indicating presence of moderate or severe depression
- Abnormal visual acuity prohibitive of tablet-based training.
- Physical handicap (motor or perceptual) that would impede training procedures.
Show all 10Show fewer
- Medical illness requiring treatment and/or significant absences during the study timeline.
- Current evidence or 2-yr history of seizures, focal brain lesion, or head injury with loss of consciousness.
- Current alcohol consumption exceeds 14 drinks per week.
- Self-reported illicit drug use.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Irvine
Irvine, California, 92697
University of California, Riverside
Riverside, California, 92521
About this study
Official title: Assessment and Training of Cognitive Function
The present study investigates how individual differences in cognitive processing contribute to the efficacy of working memory training programs in an older adult population. In a randomized crossover design, different types of working memory training interventions will be evaluated within the same participants.
Adding game-like elements to working memory training programs can increase motivation and engagement, which can increase learning. However this process, termed gamification, adds sensory complexity that can lead to increased mental load and/or distraction in older adults. Investigators hypothesize that gamification of training tasks will be beneficial to some and counterproductive to other participants. The investigators will test two models; the first assumes that participants with difficulty inhibiting distracting information will show better learning and transfer when assigned to non-gamified training, whereas those with more distractor tolerance will show better learning and transfer when assigned to gamified training. The second model states that the outcomes of the intervention will be better predicted by performance on measures of general cognitive ability.
In a separate study, the investigators will compare working memory training that contains rich, multisensory information with a training program that contains only visual information. Here they will also test two models; the first assumes that participants with difficulty binding two stimulus streams will show better learning and transfer when assigned to visual-only working memory training, whereas participants who do not have this difficulty will show better learning and transfer when assigned to multisensory working memory training. The second model states that the outcomes of the intervention will be better predicted by performance on measures of general cognitive ability.
Read the detailed description
Three randomized cross-over trials will be conducted to obtain within-subject comparisons of training with enriched (game-like) versions of working memory training tasks compared to basic (non-gamified) versions of these tasks. In the N-back trial, participants will be assigned to Non-Gamified N-back training and Gamified N-back training. In the Span trial, they will be assigned to Non-Gamified Span training and Gamified Span training and in the Multisensory trial, they will be assigned to Non-gamified Unisensory N-back training and Non-gamified Multisensory N-back training.
Each trial involves a total of 50 sessions per participant: the first few sessions consist of completing questionnaires and computerized cognitive assessments (pre-test). Participants then complete 20 sessions of working memory training. After a mid-test, they complete 20 sessions of a different type of working memory training. Post-test is administered upon training completion, and at least a month later, participants complete 3 follow-up sessions. The study can be administered either in person or remotely; however, the investigators anticipate that most participants will complete the study remotely.
- Conditions
- Cognitive Change
- Being tested
- N-back, Span, Multisensory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-backBehavioural
The training program is a personal device-based adaptive version of a visual N-back task, either devoid of game elements or embedded in a gamified platform game
SpanBehavioural
The training program is a personal device-based adaptive version of a visual working memory span task, either devoid of game elements or embedded in a gamified platform game
MultisensoryBehavioural
The training program is a personal device-based adaptive version of an N-back task that features visual stimuli (Unisensory) or visual stimuli paired with unique sounds (Multisensory) and is devoid of game elements
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Active comparator | Training type 1 will be administered in the first part of the crossover trial and Training type 2 will be administered in the second part of the trial. Each training part consists of 20 twenty-minute long sessions with the recommended frequency of 2 sessions per work day. Thus each training part can be completed in 10 work days (2 weeks). Receives: Behavioral: N-back; Behavioral: Span; Behavioral: Multisensory |
| Condition 2 | Active comparator | Training type 2 will be administered in the first part of the crossover trial and Training type 1 will be administered in the second part of the trial. Each training part consists of 20 twenty-minute long sessions with the recommended frequency of 2 sessions per work day. Thus each training part can be completed in 10 work days (2 weeks). Receives: Behavioral: N-back; Behavioral: Span; Behavioral: Multisensory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in N-level
N-back is a tablet-based updating working memory task. Participants see a consecutive stream of pictures and are asked to tap the pictures that match those presented N items earlier. All participants will complete 1-back and 2-back, progression to 3-back and beyond is based on performance on the previous level (no more than 4 errors). The outcome measure is the change in the highest N-level reached on the task compared to baseline at Day 2.
Measured: Day 24, Day 46, Day 78
Change in Corsi span
Corsi is a tabled-based measure of spatial working memory. Participants see characters emerge one at a time from twelve possible locations and are asked to repeat the sequence by tapping on the locations in the correct order. The task starts with set size two and increases in difficulty using an adaptive algorithm. Participants first play Simple Corsi (without a distractor task), followed by Complex Corsi (with a distractor task). The outcome measure is change in overall span, calculated as the sum of the two highest set sizes that can be recalled in Simple and Complex Corsi tasks, at the point of measurement compared to baseline at Day 3.
Measured: Day 25, Day 47, Day 79
Change in Inhibitory Control Composite Score
The score is the mean of standardized dependent variables on tablet-based inhibitory control tasks. The outcome measure is the change in the composite score at the point of measurement compared to baseline at Day 2.
Measured: Day 24, Day 46, Day 78
Change in Everyday Memory Questionnaire Revised
The Everyday Memory Questionnaire Revised (Royle \& Lincoln, 2008) consists of 13 items that describe everyday events that might involve forgetting. Participants are asked how often on average they think each one has happened to them over the past month on a 5-point scale (0-4) and the total score is calculated as the sum of all responses. The minimum total score is 0 and the maximum is 52, with higher scores indicative of greater presence of memory difficulties. The outcome measure is the change in total score at the point of measurement compared to baseline at Day 1.
Measured: Day 24, Day 46, Day 77
Secondary outcomes (9)
Training Experience Enjoyment Subscale I
Scores range from 1 to 5, with higher scores indicative of greater enjoyment of the training task.
Measured: Day 24
Training Experience Enjoyment Subscale II
Scores range from 1 to 5, with higher scores indicative of greater enjoyment of the training task.
Measured: Day 46
Training Experience Difficulty Subscale I
Score range from 1 to 10, with scores 1-3 indicating that the training was too easy, scores 4-7 indicating that the training was of appropriate difficulty, and scores 8-10 indicating that it was too difficult.
Measured: Day 24
Training Experience Difficulty Subscale II
Score range from 1 to 10, with scores 1-3 indicating that the training was too easy, scores 4-7 indicating that the training was of appropriate difficulty, and scores 8-10 indicating that it was too difficult.
Measured: Day 46
Training Experience Subjective Progress Subscale I
Scores range from 1 to 5, with higher scores indicative of greater subjective progress on the training task.
Measured: Day 24
Training Experience Subjective Progress Subscale II
Scores range from 1 to 5, with higher scores indicative of greater subjective progress on the training task.
Measured: Day 46
Training Experience Interface Subscale I
Scores range from 1 to 5, with higher scores indicative of greater satisfaction with the interface (software).
Measured: Day 24
Training Experience Interface Subscale II
Scores range from 1 to 5, with higher scores indicative of greater satisfaction with the interface (software).
Measured: Day 46
Exit Survey
Participants are asked 5 open-ended questions about their subjective experience of participating in the study.
Measured: Day 79
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start17 Mar 2022
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three randomized crossover trials (N-back, Span and Multisensory) will be conducted and in each trial, participants will be randomly assigned to 1 of 2 conditions: Condition 1 consists of training type 1 followed by training type 2, whereas Condition 2 consists of training type 2 followed by training type 1. In the N-back trial, participants will be assigned to Non-Gamified N-back training and Gamified N-back training. In the Span trial, they will be assigned to Non-Gamified Span training and Gamified Span training and in the Multisensory trial, they will be assigned to Non-gamified Unisensory N-back training and Non-gamified Multisensory N-back training.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Riverside, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Susanne Jaeggi, Northeastern University
- Investigators
- Aaron R Seitz, Phd, Principal investigator, University of California, RiversideSusanne M Jaeggi, Phd, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396586
- Sponsor's protocol ID
- 20141547
- Other IDs
- 1R21AG069428-01A1, 5R21AG069428-02
- Status last verified
- Jan 2025
- First submitted
- 21 Apr 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (anonymized).
Publications
Pahor A, Mester RE, Carrillo AA, Ghil E, Reimer JF, Jaeggi SM, Seitz AR. UCancellation: A new mobile measure of selective attention and concentration. Behav Res Methods. 2022 Oct;54(5):2602-2617. doi: 10.3758/s13428-021-01765-5. Epub 2022 Feb 1.
PubMed 35106729Pahor A, Stavropoulos T, Jaeggi SM, Seitz AR. Validation of a matrix reasoning task for mobile devices. Behav Res Methods. 2019 Oct;51(5):2256-2267. doi: 10.3758/s13428-018-1152-2.
PubMed 30367386Royle J, Lincoln NB. The Everyday Memory Questionnaire-revised: development of a 13-item scale. Disabil Rehabil. 2008;30(2):114-21. doi: 10.1080/09638280701223876.
PubMed 17852284Pahor A, Collins C, Smith RN, Moon A, Stavropoulos T, Silva I, Peng E, Jaeggi SM, Seitz AR. Multisensory Facilitation of Working Memory Training. J Cogn Enhanc. 2021 Sep;5(3):386-395. doi: 10.1007/s41465-020-00196-y. Epub 2020 Nov 27.
PubMed 34485810Sandeep S, Shelton CR, Pahor A, Jaeggi SM, Seitz AR. Application of Machine Learning Models for Tracking Participant Skills in Cognitive Training. Front Psychol. 2020 Jul 22;11:1532. doi: 10.3389/fpsyg.2020.01532. eCollection 2020.
PubMed 32793032
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Training of Cognitive Function
- ClinicalTrials.gov ID
- NCT05396586
- Acronym / sponsor ID
- 20141547
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- University of California, Riverside, National Institute on Aging (NIA)
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 31 May 2022 (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 present study investigates how individual differences in cognitive processing contribute to the efficacy of working memory training programs in an older adult population. In a randomized crossover design, different types of working memory training interventions will be evaluated within the same participants.
Adding game-like elements to working memory training programs can increase motivation and engagement, which can increase learning. However this process, termed gamification, adds sensory complexity that can lead to increased mental load and/or distraction in older adults. Investigators hypothesize that gamification of training tasks will be beneficial to some and counterproductive to other participants. The investigators will test two models; the first assumes that participants with difficulty inhibiting distracting information will show better learning and transfer when assigned to non-gamified training, whereas those with more distractor tolerance will show better learning and transfer when assigned to gamified training. The second model states that the outcomes of the intervention will be better predicted by performance on measures of general cognitive ability.
In a separate study, the investigators will compare working memory training that contains rich, multisensory information with a training program that contains only visual information. Here they will also test two models; the first assumes that participants with difficulty binding two stimulus streams will show better learning and transfer when assigned to visual-only working memory training, whereas participants who do not have this difficulty will show better learning and transfer when assigned to multisensory working memory training. The second model states that the outcomes of the intervention will be better predicted by performance on measures of general cognitive ability.
Detailed description
Three randomized cross-over trials will be conducted to obtain within-subject comparisons of training with enriched (game-like) versions of working memory training tasks compared to basic (non-gamified) versions of these tasks. In the N-back trial, participants will be assigned to Non-Gamified N-back training and Gamified N-back training. In the Span trial, they will be assigned to Non-Gamified Span training and Gamified Span training and in the Multisensory trial, they will be assigned to Non-gamified Unisensory N-back training and Non-gamified Multisensory N-back training.
Each trial involves a total of 50 sessions per participant: the first few sessions consist of completing questionnaires and computerized cognitive assessments (pre-test). Participants then complete 20 sessions of working memory training. After a mid-test, they complete 20 sessions of a different type of working memory training. Post-test is administered upon training completion, and at least a month later, participants complete 3 follow-up sessions. The study can be administered either in person or remotely; however, the investigators anticipate that most participants will complete the study remotely.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Three randomized crossover trials (N-back, Span and Multisensory) will be conducted and in each trial, participants will be randomly assigned to 1 of 2 conditions: Condition 1 consists of training type 1 followed by training type 2, whereas Condition 2 consists of training type 2 followed by training type 1. In the N-back trial, participants will be assigned to Non-Gamified N-back training and Gamified N-back training. In the Span trial, they will be assigned to Non-Gamified Span training and Gamified Span training and in the Multisensory trial, they will be assigned to Non-gamified Unisensory N-back training and Non-gamified Multisensory N-back training.
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Active comparator | Behavioral: N-back, Behavioral: Span, Behavioral: MultisensoryTraining type 1 will be administered in the first part of the crossover trial and Training type 2 will be administered in the second part of the trial. Each training part consists of 20 twenty-minute long sessions with the recommended frequency of 2 sessions per work day. Thus each training part can be completed in 10 work days (2 weeks). |
| Condition 2 | Active comparator | Behavioral: N-back, Behavioral: Span, Behavioral: MultisensoryTraining type 2 will be administered in the first part of the crossover trial and Training type 1 will be administered in the second part of the trial. Each training part consists of 20 twenty-minute long sessions with the recommended frequency of 2 sessions per work day. Thus each training part can be completed in 10 work days (2 weeks). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50-85 years of age
- Able to understand and speak English and follow study procedures
- Does not have a psychological or neurological condition that would prevent being able to give consent to participate
- Not currently involved in any other cognitive or memory training studies
Key exclusion criteria (10 listed)
- Formal diagnosis of dementia or other neurological disease, including Mild cognitive impairment.
- A final total score below 17 on Montreal Cognitive Assessment - Blind (telephone) version.
- Score of 10 or more on the Generalized Anxiety Questionnaire (GAD7; Spitzer et al., 2006, Archives of Internal Medicine), indicating presence of moderate or severe anxiety
- Score of 9 or more on Geriatric depression scale (GDS15; Yesavage et al., 1982) indicating presence of moderate or severe depression
- Abnormal visual acuity prohibitive of tablet-based training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-backThe training program is a personal device-based adaptive version of a visual N-back task, either devoid of game elements or embedded in a gamified platform game | Behavioural | Condition 1, Condition 2 |
| SpanThe training program is a personal device-based adaptive version of a visual working memory span task, either devoid of game elements or embedded in a gamified platform game | Behavioural | Condition 1, Condition 2 |
| MultisensoryThe training program is a personal device-based adaptive version of an N-back task that features visual stimuli (Unisensory) or visual stimuli paired with unique sounds (Multisensory) and is devoid of game elements | Behavioural | Condition 1, Condition 2 |
Primary outcome
Change in N-level
Time frame: Day 24, Day 46, Day 78
N-back is a tablet-based updating working memory task. Participants see a consecutive stream of pictures and are asked to tap the pictures that match those presented N items earlier. All participants will complete 1-back and 2-back, progression to 3-back and beyond is based on performance on the previous level (no more than 4 errors). The outcome measure is the change in the highest N-level reached on the task compared to baseline at Day 2.
Change in Corsi span
Time frame: Day 25, Day 47, Day 79
Corsi is a tabled-based measure of spatial working memory. Participants see characters emerge one at a time from twelve possible locations and are asked to repeat the sequence by tapping on the locations in the correct order. The task starts with set size two and increases in difficulty using an adaptive algorithm. Participants first play Simple Corsi (without a distractor task), followed by Complex Corsi (with a distractor task). The outcome measure is change in overall span, calculated as the sum of the two highest set sizes that can be recalled in Simple and Complex Corsi tasks, at the point of measurement compared to baseline at Day 3.
Change in Inhibitory Control Composite Score
Time frame: Day 24, Day 46, Day 78
The score is the mean of standardized dependent variables on tablet-based inhibitory control tasks. The outcome measure is the change in the composite score at the point of measurement compared to baseline at Day 2.
Change in Everyday Memory Questionnaire Revised
Time frame: Day 24, Day 46, Day 77
The Everyday Memory Questionnaire Revised (Royle \& Lincoln, 2008) consists of 13 items that describe everyday events that might involve forgetting. Participants are asked how often on average they think each one has happened to them over the past month on a 5-point scale (0-4) and the total score is calculated as the sum of all responses. The minimum total score is 0 and the maximum is 52, with higher scores indicative of greater presence of memory difficulties. The outcome measure is the change in total score at the point of measurement compared to baseline at Day 1.
9 secondary outcomes
Training Experience Enjoyment Subscale I
Time frame: Day 24
Training Experience Enjoyment Subscale II
Time frame: Day 46
Training Experience Difficulty Subscale I
Time frame: Day 24
Training Experience Difficulty Subscale II
Time frame: Day 46
Training Experience Subjective Progress Subscale I
Time frame: Day 24
Training Experience Subjective Progress Subscale II
Time frame: Day 46
Training Experience Interface Subscale I
Time frame: Day 24
Training Experience Interface Subscale II
Time frame: Day 46
Exit Survey
Time frame: Day 79
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 35106729Pahor A, Mester RE, Carrillo AA, Ghil E, Reimer JF, Jaeggi SM, Seitz AR. UCancellation: A new mobile measure of selective attention and concentration. Behav Res Methods. 2022 Oct;54(5):2602-2617. doi: 10.3758/s13428-021-01765-5. Epub 2022 Feb 1.
- Background: PubMed 30367386Pahor A, Stavropoulos T, Jaeggi SM, Seitz AR. Validation of a matrix reasoning task for mobile devices. Behav Res Methods. 2019 Oct;51(5):2256-2267. doi: 10.3758/s13428-018-1152-2.
- Background: PubMed 17852284Royle J, Lincoln NB. The Everyday Memory Questionnaire-revised: development of a 13-item scale. Disabil Rehabil. 2008;30(2):114-21. doi: 10.1080/09638280701223876.
- Background: PubMed 34485810Pahor A, Collins C, Smith RN, Moon A, Stavropoulos T, Silva I, Peng E, Jaeggi SM, Seitz AR. Multisensory Facilitation of Working Memory Training. J Cogn Enhanc. 2021 Sep;5(3):386-395. doi: 10.1007/s41465-020-00196-y. Epub 2020 Nov 27.
- Background: PubMed 32793032Sandeep S, Shelton CR, Pahor A, Jaeggi SM, Seitz AR. Application of Machine Learning Models for Tracking Participant Skills in Cognitive Training. Front Psychol. 2020 Jul 22;11:1532. doi: 10.3389/fpsyg.2020.01532. eCollection 2020.
- Individual participant dataSharing planned: Yes. All individual participant data (anonymized).
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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. This study is not recruiting at the moment.
Aaron R Seitz, Phd principal investigator
University of California, Riverside
Susanne M Jaeggi, Phd principal investigator
University of California, Irvine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-back, Span and Multisensory in people with Cognitive Change, run by Northeastern University at 2 sites in United States.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in N-level (time frame: Day 24, Day 46, Day 78). The study lists 4 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 NCT05396586, which also lists 5 linked publications.
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 12 Mar 2025.