Mild Cognitive Impairment (MCI)ADAPT-MCI-01NCT07174869
A Study To Assess The Feasibility Of Indivi Mobile Application In Monitoring Cognitive Performance In Aging Population
An observational study of Mild Cognitive Impairment (MCI) and Mild Alzheimer Disease, run by Indivi AG at 1 site in United States.
Trial summary
The goal of this observational study is to evaluate the functionality and usability of Indivi mobile application-based cognitive activities in people with mild cognitive impairment/mild Alzheimer's disease (PwMCI/AD) and healthy controls (HC). Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Mild Alzheimer Disease
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2025to 9 Jul 2026
- Phase
- Observational
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Boston University Alzheimer's Disease Research Center (BU ADRC)
Who may be able to join
- Participant is part of BU-ADRC cohort.
- Participant is diagnosed with MCI, mild AD, or is classified as HC per BU-ADRC, with available required data for inclusion obtained less than 2 years before the inclusion.
- Participant is between 50 and 90 years old, included.
- Participant is able to use a smartphone.
- Participant has sufficient knowledge of the English language.
- Participant is able to and has an intention to follow the study procedures.
- Informed Consent as documented by signature.
Who cannot join
- Participant has any neurological condition that may be contributing to cognitive impairment (above and beyond that caused by the subject's MCI or AD).
- Participant has psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures.
- Participant has a history of stroke or seizures within the last 24 months.
- Participant has a Geriatric Depression Scale (GDS) score ≥8.
- Participant has a severe visual or hearing impairment that would interfere with capacity to perform cognitive assessments.
- Known or suspected non-compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Medicine
Boston, Massachusetts, 02118
About this study
Official title: A Pilot Study To Assess The Dynamic Difficulty Adjustment In Personalized Testing For Persons With MCI And Matched Healthy Controls
The goal of this observational study is to evaluate the functionality and usability of Indivi mobile application-based cognitive activities in people with mild cognitive impairment/mild Alzheimer's disease (PwMCI/AD) and healthy controls (HC). This application uses a dynamic difficulty adjustment (DDA) system that customizes the level of the cognitive activities to each user.
The main questions it aims to answer are:
Read more
- Does the DDA system reach a stable difficulty level at the same rate for both PwMCI/AD and HC?
- Is the stable difficulty level reached by the DDA system different for PwMCI/AD compared to HC?
Researchers will also compare cognitive activities results and other aspects of the mobile application's performance to see if the application can validly distinguish between the two groups.
Participants will use the Indivi mobile application, with its embedded DDA system, for a 6-week period.
- Medical subject headings
- Cognitive Dysfunction
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 |
|---|---|---|
| PwMCI/AD | Persons with Mild Cognitive Impairment or mild Alzheimer's Disease | |
| HC | Healthy Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of test iterations until stable difficulty level is reached
Stable difficulty level is defined as no increase in difficulty across 3 consecutive test iterations. Comparison will be made between PwMCI and HC.
Measured: During the 6-week study period.
Distribution of participants across assessment levels at steady-state difficulty
Steady-state difficulty is defined as no increase in difficulty across 3 consecutive test iterations. The outcome will describe the distribution pattern of participants across the available assessment levels at steady-state.
Measured: During the 6-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start19 Sep 2025
- Primary completion9 Jul 2026
- Study completion9 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivi AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174869
- Sponsor's protocol ID
- H-45373
- Acronym
- ADAPT-MCI-01
- Status last verified
- Aug 2026
- First submitted
- 9 Sep 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study To Assess The Dynamic Difficulty Adjustment In Personalized Testing For Persons With MCI And Matched Healthy Controls
- ClinicalTrials.gov ID
- NCT07174869
- Acronym / sponsor ID
- ADAPT-MCI-01 / H-45373
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Indivi AGIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 16 Sep 2025 (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 observational study is to evaluate the functionality and usability of Indivi mobile application-based cognitive activities in people with mild cognitive impairment/mild Alzheimer's disease (PwMCI/AD) and healthy controls (HC). This application uses a dynamic difficulty adjustment (DDA) system that customizes the level of the cognitive activities to each user.
The main questions it aims to answer are:
- Does the DDA system reach a stable difficulty level at the same rate for both PwMCI/AD and HC?
- Is the stable difficulty level reached by the DDA system different for PwMCI/AD compared to HC?
Researchers will also compare cognitive activities results and other aspects of the mobile application's performance to see if the application can validly distinguish between the two groups.
Participants will use the Indivi mobile application, with its embedded DDA system, for a 6-week period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PwMCI/AD | – | –Persons with Mild Cognitive Impairment or mild Alzheimer's Disease |
| HC | – | –Healthy Controls |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Boston University Alzheimer's Disease Research Center (BU ADRC)
Key inclusion criteria (7 listed)
- Participant is part of BU-ADRC cohort.
- Participant is diagnosed with MCI, mild AD, or is classified as HC per BU-ADRC, with available required data for inclusion obtained less than 2 years before the inclusion.
- Participant is between 50 and 90 years old, included.
- Participant is able to use a smartphone.
- Participant has sufficient knowledge of the English language.
Key exclusion criteria (6 listed)
- Participant has any neurological condition that may be contributing to cognitive impairment (above and beyond that caused by the subject's MCI or AD).
- Participant has psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures.
- Participant has a history of stroke or seizures within the last 24 months.
- Participant has a Geriatric Depression Scale (GDS) score ≥8.
- Participant has a severe visual or hearing impairment that would interfere with capacity to perform cognitive assessments.
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
Number of test iterations until stable difficulty level is reached
Time frame: During the 6-week study period.
Stable difficulty level is defined as no increase in difficulty across 3 consecutive test iterations. Comparison will be made between PwMCI and HC.
Distribution of participants across assessment levels at steady-state difficulty
Time frame: During the 6-week study period
Steady-state difficulty is defined as no increase in difficulty across 3 consecutive test iterations. The outcome will describe the distribution pattern of participants across the available assessment levels at steady-state.
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 11 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mild Cognitive Impairment (MCI) and Mild Alzheimer Disease, run by Indivi AG 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 7 inclusion and 6 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 11 Aug 2026. 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.
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?
Number of test iterations until stable difficulty level is reached (time frame: During the 6-week study period.). The study lists 2 primary outcomes in all. 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 11 Aug 2026.