Memory FunctionsNCT07416019
Test-Retest Reliability of DiaMem
An observational study of Memory Functions and Cognition, run by Xuanwu Hospital, Beijing.
Trial summary
The goal of this observational study is to learn how reliable the DiaMem memory assessment tool is when used repeatedly over a short period. The main question it aims to answer is: How consistent are the DiaMem test scores when the same person takes the test multiple times? Researchers will also compare DiaMem with… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Memory Functions, Cognition
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 14 Feb 2026to Nov 2026
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll a community-based sample of 30 older adults aged 60 years and above. Participants will be stratified by age into three groups (60-69, 70-79, and ≥80 years) to ensure representation across older age ranges. While the primary focus is on validating a measurement tool and not on treating a specific disease, the sample may include individuals with subjective memory complaints or varying cognitive abilities as typically found in a community setting, provided they meet all eligibility criteria.
Who may be able to join
- -Age ≥ 60 years, regardless of gender. Willing and able to provide signed informed consent.
Who cannot join
- Corrected visual acuity insufficient to see text/images on a mobile phone screen.
- Corrected hearing inability to hear prompts at the phone's maximum volume. Severe upper limb dysfunction (e.g., severe arthritis, Parkinson's tremor) preventing stable phone operation.
- Does not own a smartphone, or owns one that cannot properly run WeChat mini-programs.
- History of severe mental illness (e.g., major depressive disorder, bipolar disorder, schizophrenia).
- History of long-term alcohol or substance abuse.
- Hospitalization, emergency visit, or major life event (e.g., myocardial infarction, marriage/divorce, fall) within the past month.
- Use of antipsychotics, antidepressants, antiepileptics, sedatives, or plans to use them within the next two weeks.
- Planned travel (e.g., inter-city) or other major arrangements likely to interrupt study participation within the next two weeks.
About this study
Official title: An Exploratory Study on the Test-Retest Reliability of the Memory Function Assessment Tool DiaMem
The goal of this observational study is to learn how reliable the DiaMem memory assessment tool is when used repeatedly over a short period. The main question it aims to answer is:
- How consistent are the DiaMem test scores when the same person takes the test multiple times?
Read more
Researchers will also compare DiaMem with another digital memory test called MemTrax to gather initial information.
Participants will:
- Be adults aged 60 or older.
- Complete a standard memory test and a thinking skills test.
- Be randomly split into two groups (A and B).
- Take memory tests once a day for 6 days in a row.
Group A will take the DiaMem test 3 times first, then the MemTrax test 3 times.
Group B will take the tests in the opposite order.
- Answer a short questionnaire about how easy the tests were to use.
- Conditions
- Memory Functions, 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 |
|---|---|---|
| Group A | 3 sessions of DiaMem testing followed by 3 sessions of MemTrax testing. | |
| Group B | 3 sessions of MemTrax testing followed by 3 sessions of DiaMem testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest reliability of the DiaMem total score
The test-retest reliability (repeatability) of the total score from the DiaMem digital memory assessment tool will be evaluated. Reliability will be quantified using the Intraclass Correlation Coefficient (ICC), calculated from the DiaMem total scores obtained across three test sessions.
Measured: Days 1 to 3 in Group A and Days 4 to 6 in Group B
Secondary outcomes (4)
Test-retest reliability of the MemTrax accuracy score
The test-retest reliability of the MemTrax digital memory test will be evaluated using its accuracy score (percentage of correct responses). Reliability will be quantified by the Intraclass Correlation Coefficient (ICC) calculated from the accuracy scores obtained across three test sessions.
Measured: For Group A, sessions occur on Days 4 to 6; for Group B, on Days 1 to 3.
Actual completion time for the DiaMem and MemTrax assessments
The time (in seconds) taken by participants to complete each assessment session will be recorded separately for the DiaMem and MemTrax tools. The average completion time per tool across all participants and sessions will be calculated and reported as a measure of administrative efficiency.
Measured: 6 days (Recorded at each of the 6 assessment sessions)
Mean DiaMem and MemTrax scores by age group and education level
The mean total score (for DiaMem) and mean accuracy score (for MemTrax) will be calculated and reported stratified by pre-defined participant subgroups: age groups (60-69, 70-79, ≥80 years) and educational attainment level. This aims to describe the performance distribution of the tools across different demographic segments in the study sample.
Measured: At completion of all 6 assessment sessions (Day 6)
System Usability Scale (SUS) score for the DiaMem and MemTrax tools
The perceived usability of each digital tool will be assessed using the 10-item System Usability Scale (SUS) questionnaire. Participants will complete the SUS once after their first experience with each tool (i.e., after the first DiaMem session and after the first MemTrax session). The SUS yields a single score ranging from 0 to 100, with higher scores indicating better perceived usability.
Measured: Assessed once per tool: after the first DiaMem session (Day 1 for Group A / Day 4 for Group B) and after the first MemTrax session (Day 4 for Group A / Day 1 for Group B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start14 Feb 2026 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory FunctionsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YanjunMa, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416019
- Sponsor's protocol ID
- 2026_DiaMem_01
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that will be shared include all study-collected, de-identified individual-level data necessary to reproduce the primary and secondary outcomes reported in future publications. This specifically encompasses: Participant Baseline Characteristics: Age group, sex, and education level. Assessment Scores: For the DiaMem tool: Total score, immediate memory score, and delayed memory score for each of the three sessions. For the MemTrax tool: Accuracy rate and average response time for each of the three sessions. Usability Data: System Usability Scale (SUS) score for each tool. Administrative Data: Actual completion time for each assessment session, and the assigned study group (A or B). Data will be rigorously de-identified. All direct personal identifiers (e.g., name, contact information, initials, specific birth dates) will be removed. Participants will only be referenced by a unique, anonymized study ID.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Test-Retest Reliability of the Memory Function Assessment Tool DiaMem
- ClinicalTrials.gov ID
- NCT07416019
- Acronym / sponsor ID
- 2026_DiaMem_01
- Conditions
- Memory Functions, Cognition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 14 Feb 2026 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 17 Feb 2026 (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 learn how reliable the DiaMem memory assessment tool is when used repeatedly over a short period. The main question it aims to answer is:
- How consistent are the DiaMem test scores when the same person takes the test multiple times?
Researchers will also compare DiaMem with another digital memory test called MemTrax to gather initial information.
Participants will:
- Be adults aged 60 or older.
- Complete a standard memory test and a thinking skills test.
- Be randomly split into two groups (A and B).
- Take memory tests once a day for 6 days in a row.
Group A will take the DiaMem test 3 times first, then the MemTrax test 3 times.
Group B will take the tests in the opposite order.
- Answer a short questionnaire about how easy the tests were to use.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –3 sessions of DiaMem testing followed by 3 sessions of MemTrax testing. |
| Group B | – | –3 sessions of MemTrax testing followed by 3 sessions of DiaMem testing. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll a community-based sample of 30 older adults aged 60 years and above. Participants will be stratified by age into three groups (60-69, 70-79, and ≥80 years) to ensure representation across older age ranges. While the primary focus is on validating a measurement tool and not on treating a specific disease, the sample may include individuals with subjective memory complaints or varying cognitive abilities as typically found in a community setting, provided they meet all eligibility criteria.
Key inclusion criteria (1 listed)
- -Age ≥ 60 years, regardless of gender. Willing and able to provide signed informed consent.
Key exclusion criteria (8 listed)
- Corrected visual acuity insufficient to see text/images on a mobile phone screen.
- Corrected hearing inability to hear prompts at the phone's maximum volume. Severe upper limb dysfunction (e.g., severe arthritis, Parkinson's tremor) preventing stable phone operation.
- Does not own a smartphone, or owns one that cannot properly run WeChat mini-programs.
- History of severe mental illness (e.g., major depressive disorder, bipolar disorder, schizophrenia).
- History of long-term alcohol or substance abuse.
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
Test-retest reliability of the DiaMem total score
Time frame: Days 1 to 3 in Group A and Days 4 to 6 in Group B
The test-retest reliability (repeatability) of the total score from the DiaMem digital memory assessment tool will be evaluated. Reliability will be quantified using the Intraclass Correlation Coefficient (ICC), calculated from the DiaMem total scores obtained across three test sessions.
4 secondary outcomes
Test-retest reliability of the MemTrax accuracy score
Time frame: For Group A, sessions occur on Days 4 to 6; for Group B, on Days 1 to 3.
Actual completion time for the DiaMem and MemTrax assessments
Time frame: 6 days (Recorded at each of the 6 assessment sessions)
Mean DiaMem and MemTrax scores by age group and education level
Time frame: At completion of all 6 assessment sessions (Day 6)
System Usability Scale (SUS) score for the DiaMem and MemTrax tools
Time frame: Assessed once per tool: after the first DiaMem session (Day 1 for Group A / Day 4 for Group B) and after the first MemTrax session (Day 4 for Group A / Day 1 for Group B)
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 17 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that will be shared include all study-collected, de-identified individual-level data necessary to reproduce the primary and secondary outcomes reported in future publications. This specifically encompasses: Participant Baseline Characteristics: Age group, sex, and education level. Assessment Scores: For the DiaMem tool: Total score, immediate memory score, and delayed memory score for each of the three sessions. For the MemTrax tool: Accuracy rate and average response time for each of the three sessions. Usability Data: System Usability Scale (SUS) score for each tool. Administrative Data: Actual completion time for each assessment session, and the assigned study group (A or B). Data will be rigorously de-identified. All direct personal identifiers (e.g., name, contact information, initials, specific birth dates) will be removed. Participants will only be referenced by a unique, anonymized study ID.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Memory Functions and Cognition, run by Xuanwu Hospital, Beijing.
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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Test-retest reliability of the DiaMem total score (time frame: Days 1 to 3 in Group A and Days 4 to 6 in Group B). 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 17 Feb 2026.