Cognitive Function AbnormalEarly Phase 1NCT05990335
Boost Study 21270 (Cognition)
A Early Phase 1 study testing mHealth application (custom) in people with Cognitive Function Abnormal, run by NXTech at 1 site in United States.
Trial summary
This study is designed to to test the technical feasibility of encouraging interaction with a mobile smartphone software package (mHealth app) for training aspects of executive function and cognition. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function Abnormal
- What is being tested?
- mHealth application (custom)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 27 Mar 2023
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and above
- Fluent in English
- Resides in the United States
- Score on prescreen task is in 25% quartile
- Familiar with smartphone device app installation and device usage
- Possesses a compatible smartphone
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile Software Application Intervention Including Cognitive Tasks
This study is designed to to test the technical feasibility of encouraging interaction with a mobile smartphone software package (mHealth app) for training aspects of executive function and cognition.
Read the detailed description
The purpose of this human subjects study is to test the technical feasibility of interaction with a mobile smartphone software package (mHealth app) for training in aspects of executive function and cognition. The study participants are healthy subjects recruited online, with consent secured at the time of screening, and with enrollees assigned to High or Low groups on the basis of initial screening task scores. Subjects are requested to participate in directed interaction activities for up to 8 weeks, with measures primarily evaluating feasibility of MHealth app package task completion and secondarily evaluating the cognitive effect of activities.
- Conditions
- Cognitive Function Abnormal
- Being tested
- mHealth application (custom)
- Keywords
- Cognition
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth application (custom)Behavioural
Smartphone based application designed to engage user executive functions
| Study group | Role | What they receive |
|---|---|---|
| Cognition exercises group I | Experimental | Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions Receives: Behavioral: mHealth application (custom) |
| Cognition exercises group C | Active comparator | Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions Receives: Behavioral: mHealth application (custom) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task Completion Rate
Percentage of participants completing minimum required weekly interactions
Measured: At 8 weeks
Secondary outcomes (1)
Change in Task Performance
Change in Human Hypothetical Choice scale (higher scores indicate a better outcome, minimum value 0 to maximum value 1), calculated as value at 8 weeks minus value at 1 week
Measured: At 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start18 Apr 2022
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive Function AbnormalStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Between subjects and within subjects mixed design, reflecting major variables of high/low group intervention/control.
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- NXTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kansas State University, National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Travis Smith, Study director, Kansas State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990335
- Sponsor's protocol ID
- NX-21270
- Other IDs
- R43DA051270
- Status last verified
- Dec 2024
- First submitted
- 31 Jul 2023
- Last updated
- 18 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Software Application Intervention Including Cognitive Tasks
- ClinicalTrials.gov ID
- NCT05990335
- Acronym / sponsor ID
- NX-21270
- Conditions
- Cognitive Function Abnormal
- Keywords
- Cognition
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- NXTechIndustry (pharma, biotech, devices)
- Collaborators
- Kansas State University, National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Posted 18 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to to test the technical feasibility of encouraging interaction with a mobile smartphone software package (mHealth app) for training aspects of executive function and cognition.
Detailed description
The purpose of this human subjects study is to test the technical feasibility of interaction with a mobile smartphone software package (mHealth app) for training in aspects of executive function and cognition. The study participants are healthy subjects recruited online, with consent secured at the time of screening, and with enrollees assigned to High or Low groups on the basis of initial screening task scores. Subjects are requested to participate in directed interaction activities for up to 8 weeks, with measures primarily evaluating feasibility of MHealth app package task completion and secondarily evaluating the cognitive effect of activities.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Between subjects and within subjects mixed design, reflecting major variables of high/low group intervention/control.
| Arm | Type | Receives |
|---|---|---|
| Cognition exercises group I | Experimental | Behavioral: mHealth application (custom)Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions |
| Cognition exercises group C | Active comparator | Behavioral: mHealth application (custom)Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years and above
- Fluent in English
- Resides in the United States
- Score on prescreen task is in 25% quartile
- Familiar with smartphone device app installation and device usage
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| mHealth application (custom)Smartphone based application designed to engage user executive functions | Behavioural | Cognition exercises group C, Cognition exercises group I |
Primary outcome
Task Completion Rate
Time frame: At 8 weeks
Percentage of participants completing minimum required weekly interactions
1 secondary outcome
Change in Task Performance
Time frame: At 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Travis Smith study director
Kansas State
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing mHealth application (custom) in people with Cognitive Function Abnormal, run by NXTech at 1 site 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 6 inclusion and 1 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 18 Dec 2024. 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Task Completion Rate (time frame: At 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2024.