Mild Cognitive ImpairmentNCT07485712
Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 2
A study testing Project 2, Phase 2: Intelligent Adaptive System in people with Mild Cognitive Impairment, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial summary
The goal of this Stage 1 (NIH Stage Model) Intervention Development cross-site project is to develop, using a user-centered design approach, and evaluate an innovative intelligent adaptive software package aimed at providing cognitive and social support and engagement to older adults with mild cognitive impairment… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Project 2, Phase 2: Intelligent Adaptive System
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Oct 2026to 31 May 2027
- Phase
- Interventional
- 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
Who may be able to join
- 62+ years of age
- Able to read English at the 6th grade level
- Have 20/60 vision with or without correction.
- Clinical diagnosis of mild cognitive impairment (MCI)
- Subjective cognitive complaints
- Evidence by clinical evaluation
Show all 12Show fewer
- Clinical Dementia Rating Global scale of 0.5-2.0
- Probable MCI
- Montreal Cognitive Assessment (MoCA) score of 18-26
- No major Instrumental activities of daily living (IADL) impairments
- Geriatric Depression Scale of 4 or Below
- No diagnosis of dementia
Who cannot join
- Blind or have visual impairments that limit their ability to view the technology.
- Deaf or have hearing impairments that limit their ability to answer telephone queries.
- Have a life-limiting/terminal illness
- Severe motor impairment (e.g., severe tremors or debilitating arthritis in their hands) that impairs ability to speak or use dominant hand
- Cognitive impairment (MOCA ≤ 25)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Illinois Urbana-Champaign
Champaign, Illinois, 61820
Wendy Rogers, PhD, 217-300-1470, wendyr@illinois.edu
Wendy Rogers, PhD
Weill Cornell Medicine
New York, New York, 10065
Chelsie Burchett, MA, 646-962-7141, cob2014@med.cornell.edu
Sara Czaja, PhD
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Center for Research and Education on Aging and Technology Enhancement - CREATE V
The goal of this Stage 1 (NIH Stage Model) Intervention Development cross-site project is to develop, using a user-centered design approach, and evaluate an innovative intelligent adaptive software package aimed at providing cognitive and social support and engagement to older adults with mild cognitive impairment (MCI). The system will be designed to adapt to the needs and abilities of the user. The investigator's goal is to develop a unique and highly innovative technology tool that can provide adaptive support to aging individuals with MCI, even as cognition might deteriorate further. Speech data collected as part of an embedded reminiscence feature will advance fundamental knowledge of how speech and language production data might serve as an early indicator of cognitive decline.
Read the detailed description
Deployment of technology in healthcare and day-to- day activities is increasing and advances in technology such as artificial intelligence (AI) are increasingly aimed at supporting older adults. Yet, aging adults are often ignored in design, and robust research evaluating the usability, safety, and efficacy of these systems with older adults is limited. Even among older technology adopters, rapid changes in technology pose challenges in terms of the constant need for adaptation and continual learning. Further, there remains a lag in uptake among many older adult sub-groups, including ethnic minorities, older cohorts, those of lower socio-economic status, those living in a rural location, or with a cognitive impairment such as Mild Cognitive Impairment (MCI) or Alzheimer's Disease/Alzheimer's Disease Related Dementias (AD/ADRD). The goal of CREATE V is to harness the potential benefits and power of technology to maintain, support, and foster the cognitive, emotional, and physical health of aging adults to enhance independence, well-being, and quality of life. Given that age represents a significant risk factor for cognitive impairments such as MCI and AD/ADRD, and the criticality of cognition to everyday functioning, a thrust of the research investigators planned research is on using emerging technologies to help maintain cognitive health and provide support for those with cognitive impairments. CREATE V has a fresh vision, a focus on emerging technologies, expanded research teams, new populations such as those with cognitive impairments, and technological capabilities.
Project 2: Phase 1 of the project will yield important information on the feasibility of using technology-based approaches to support everyday activities and cognition for persons with MCI and insight on barriers to the implementation of technology-based interventions. The investigators will also gain understanding of the challenges aging adults with MCI encounter in everyday activities.
In phase 2, akin to Stage 1b, the study will involve pilot testing to evaluate the feasibility, acceptability, and usability of the system (primary outcomes) with a diverse sample of individuals with MCI at each site. Investigators will gather preliminary data on efficacy of the system with respect to secondary outcomes such as cognition, perceptions of memory functioning, social connectivity, social support, loneliness, technology proficiency, and the performance of everyday tasks. Investigators will collect real time data on system use and system adaptations. Investigators will examine potential negative consequences of use of the system, such as decreases in social networks or interactions or negative changes in life space. All assessments will occur in the participants' living environment by trained research assistants. An assessor other than the one who conducted the baseline assessment, will conduct follow-up assessments to minimize bias (i.e., assessors will be blinded to treatment condition).
Project 2 record was originally listed under NCT05811338.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Project 2, Phase 2: Intelligent Adaptive System
- Keywords
- Technology
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project 2, Phase 2: Intelligent Adaptive SystemBehavioural
An innovative intelligent adaptive software package aimed at providing social and cognitive support to older adults with MCI. The system will be designed to adapt to the needs and abilities of the user.
| Study group | Role | What they receive |
|---|---|---|
| Project 2 - Phase 2: Active Intervention Group | Experimental | Participants will receive a tablet with the adaptive program and be provided with internet service following the baseline assessment.
Participants will receive a 3-day training in their home that will include basic tablet/internet training and training on the features of the system. The training will also encompass a module on internet etiquette and security against potential spam and fraud. Participants will be provided with practice tasks in between sessions. Participants will be provided with a "hands-on" performance assessment at the end of the second session and concepts/procedures that are problematic will be reviewed. Receives: Behavioral: Project 2, Phase 2: Intelligent Adaptive System |
| Project 2 - Phase 2: Waitlist Control | Active comparator | Participants will receive a 3-day training in their home. Participants will also receive a tablet, internet support for 12 months and training. This will include instructions for accessing content pertaining to the research study. Receives: Behavioral: Project 2, Phase 2: Intelligent Adaptive System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Project 2, Phase 2: Perceived System Usability of the CAST Program as Measured by the number of times used per day
The CAST system or tablet usability will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, by the number of days used using the sum of times the system was used per day or the average, starting from baseline through six months. Measure is to be developed based on phase 1 of the study.
Measured: Baseline through 6 months
Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of times the system was used per day
The CAST system or tablet usability will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, using the sum of times the system was used per day or the average starting from baseline through six months. Measure is to be developed based on phase 1 of the study.
Measured: Baseline through 6 months
Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of features used per day
The CAST system or tablet usability will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, by number of features used per day, using the sum of numbers of features used per day or the average starting from baseline through six months. Measure is to be developed based on phase 1 of the study.
Measured: Baseline through 6 months
Project 2, Phase 2: Perceived Ease of Use of the CAST Program, assessed using the Perceived Ease of Use Questionnaire
Utilizing a 12-item scale (Perceived Ease of Use Questionnaire) which includes two subscales (perceived usefulness and perceived ease of use) with Likert response scales ranging from. 1 (Strongly disagree) - 10 (Strongly agree). The responses to the items are summed for each of the subscales. To assess ease of use, the investigators will evaluate responses to the perceived ease of use subscale.
Measured: 6 months post intervention
Project 2, Phase 2: Perceived System Usefulness of the CAST Program, assessed using the Perceived Usefulness Questionnaire
Will assess participants' perception of technology-based intervention usefulness. Utilizing a 12-item scale (Perceived Usefulness Questionnaire) which includes two subscales (perceived usefulness and perceived ease of use) with Likert response scales ranging from. 0 (Strongly disagree) - 4 (Strongly agree). Higher sores indicate perceived ease of use of the CAST program. The responses to the items are summed for each of the subscales.
Measured: 6-months post intervention
Project 2, Phase 2: Mean scores of participants' perception of CAST program usability and usefulness, assessed using the Usability Metric for user Experience (UMUX-Lite) questionnaire
Will assess participants' perception of technology-based intervention ease of use and usefulness. The Usability Metric for User Experience (UMUX-Lite) is a two-item Likert scale used for the subjective assessment of an application's perceived usability. On a 7- point scale, with 0 being strongly disagree and 6 being strongly agree, higher scores are reflective of a greater satisfaction with the system. The scoring range is from 0 to 14. A higher accumulated score is representative of a higher perception of usability.
Measured: 6-months post intervention
Secondary outcomes (5)
Project 2, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure
Scales used to measure two aspects of social isolation: social disconnectedness and perceived isolation, as well as perceived availability of social support.
The Social Connectedness measure is a 15-item scale consisting of 3 sections with different likert response scale. Section 1 is a 4-item scale ranging from 0 - 5 points (20 total points). Section 2 is a 6-item scale ranging from 1 - 3 points (18 total points). Section 3 is a 5-item scale ranging from 1 - 5 points (25 total points). For Section 1, a higher score is reflective of increased connectedness while for Section 2 and 3, a higher score is a reflective of a higher level of disconnectedness. For sections 1-3, a mean difference in score will be calculated.
Measured: Baseline and 6 month post intervention
Project 2, Phase 2: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire
Will assess the participant's quality of life by having the participant rate different aspects of their life using one of four words: poor, fair, good, or excellent. They are instructed to think about different aspects of their life, like physical health, energy, family, money, and others to assess their situation in each area.
The Quality of Life questionnaire is a 13-item scale with Likert response scales ranging between 1 and 4 points. The measure's total score can range between 13 - 52 points. A higher total score is reflective of a higher quality of life while a lower score is reflective of a poorer quality of life.
Measured: Baseline and 6 month post intervention
Project 2, Phase 2: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale
The CES-D is a self-report depression scale for research in general population. It is a 20 item questionnaire consisting of likert response scales ranging from 0-3 points. The total score range is 0 - 60 points. Higher scores indicate participants have a greater level of self reported depression.
Measured: Baseline and 6 month post intervention
Project 2, Phase 2: Mean Difference in score of participants self-reported health, assessed using the 36-Item Short Form Health Survey questionnaire (SF-36 Short Form)
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability. The 8 subscales or domains are as follows:
Physical functioning (10 items); Role limitations due to physical health (4 items); Role limitations due to emotional problems (4 items); Energy/fatigue (4 items); Emotional well-being (5 items); Social functioning (2 items); Pain (2 items); General health (5 items).
Measured: Baseline and 6 month post intervention
Project 2, Phase 2: Mean Difference in scores of participants' perceived memory function, assessed using the Perception of Memory Function questionnaire
The Perception of Memory Function Questionnaire is a self-report questionnaire for clinicians and researchers to use for assessing metamemory in middle-aged and older adults. It consists of 64 items to be rated on a 7-point Likert scale; the items load on four factors, each of which associated with a specific aspect of memory. The 7-point scale ranges from major problems (1) to no problems (7). Participants on the lower end of the scoring range indicate experiencing more memory problems.
Measured: Baseline and 6 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sara J Czaja, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485712
- Sponsor's protocol ID
- 23-01025559-02
- Other IDs
- P01AG073090-01A1
- Status last verified
- Aug 2026
- First submitted
- 16 Mar 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan for resource sharing is based on the National Institutes of Health/National Institute on Aging (NIH/NIA) Data Sharing Policy. The investigators plan, consistent with the NIH goals of data sharing, is to promote use of the rich CREATE database by the larger research community as this will further the impact of CREATE and expand possibilities for collaboration. It will also allow other researchers to expedite the translation of the research findings into knowledge, products, and procedures. Further, the plan is devised to make the data as widely and freely available as possible while at the same time safeguarding the privacy of participants and protecting confidential and proprietary data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Center for Research and Education on Aging and Technology Enhancement - CREATE V
- ClinicalTrials.gov ID
- NCT07485712
- Acronym / sponsor ID
- 23-01025559-02
- Conditions
- Mild Cognitive Impairment
- Keywords
- Technology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 Mar 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 Stage 1 (NIH Stage Model) Intervention Development cross-site project is to develop, using a user-centered design approach, and evaluate an innovative intelligent adaptive software package aimed at providing cognitive and social support and engagement to older adults with mild cognitive impairment (MCI). The system will be designed to adapt to the needs and abilities of the user. The investigator's goal is to develop a unique and highly innovative technology tool that can provide adaptive support to aging individuals with MCI, even as cognition might deteriorate further. Speech data collected as part of an embedded reminiscence feature will advance fundamental knowledge of how speech and language production data might serve as an early indicator of cognitive decline.
Detailed description
Deployment of technology in healthcare and day-to- day activities is increasing and advances in technology such as artificial intelligence (AI) are increasingly aimed at supporting older adults. Yet, aging adults are often ignored in design, and robust research evaluating the usability, safety, and efficacy of these systems with older adults is limited. Even among older technology adopters, rapid changes in technology pose challenges in terms of the constant need for adaptation and continual learning. Further, there remains a lag in uptake among many older adult sub-groups, including ethnic minorities, older cohorts, those of lower socio-economic status, those living in a rural location, or with a cognitive impairment such as Mild Cognitive Impairment (MCI) or Alzheimer's Disease/Alzheimer's Disease Related Dementias (AD/ADRD). The goal of CREATE V is to harness the potential benefits and power of technology to maintain, support, and foster the cognitive, emotional, and physical health of aging adults to enhance independence, well-being, and quality of life. Given that age represents a significant risk factor for cognitive impairments such as MCI and AD/ADRD, and the criticality of cognition to everyday functioning, a thrust of the research investigators planned research is on using emerging technologies to help maintain cognitive health and provide support for those with cognitive impairments. CREATE V has a fresh vision, a focus on emerging technologies, expanded research teams, new populations such as those with cognitive impairments, and technological capabilities.
Project 2: Phase 1 of the project will yield important information on the feasibility of using technology-based approaches to support everyday activities and cognition for persons with MCI and insight on barriers to the implementation of technology-based interventions. The investigators will also gain understanding of the challenges aging adults with MCI encounter in everyday activities.
In phase 2, akin to Stage 1b, the study will involve pilot testing to evaluate the feasibility, acceptability, and usability of the system (primary outcomes) with a diverse sample of individuals with MCI at each site. Investigators will gather preliminary data on efficacy of the system with respect to secondary outcomes such as cognition, perceptions of memory functioning, social connectivity, social support, loneliness, technology proficiency, and the performance of everyday tasks. Investigators will collect real time data on system use and system adaptations. Investigators will examine potential negative consequences of use of the system, such as decreases in social networks or interactions or negative changes in life space. All assessments will occur in the participants' living environment by trained research assistants. An assessor other than the one who conducted the baseline assessment, will conduct follow-up assessments to minimize bias (i.e., assessors will be blinded to treatment condition).
Project 2 record was originally listed under NCT05811338.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project 2 - Phase 2: Active Intervention Group | Experimental | Behavioral: Project 2, Phase 2: Intelligent Adaptive SystemParticipants will receive a tablet with the adaptive program and be provided with internet service following the baseline assessment. Participants will receive a 3-day training in their home that will include basic tablet/internet training and training on the features of the system. The training will also encompass a module on internet etiquette and security against potential spam and fraud. Participants will be provided with practice tasks in between sessions. Participants will be provided with a "hands-on" performance assessment at the end of the second session and concepts/procedures that are problematic will be reviewed. |
| Project 2 - Phase 2: Waitlist Control | Active comparator | Behavioral: Project 2, Phase 2: Intelligent Adaptive SystemParticipants will receive a 3-day training in their home. Participants will also receive a tablet, internet support for 12 months and training. This will include instructions for accessing content pertaining to the research study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 62+ years of age
- Able to read English at the 6th grade level
- Have 20/60 vision with or without correction.
- Clinical diagnosis of mild cognitive impairment (MCI)
- Subjective cognitive complaints
Key exclusion criteria (5 listed)
- Blind or have visual impairments that limit their ability to view the technology.
- Deaf or have hearing impairments that limit their ability to answer telephone queries.
- Have a life-limiting/terminal illness
- Severe motor impairment (e.g., severe tremors or debilitating arthritis in their hands) that impairs ability to speak or use dominant hand
- Cognitive impairment (MOCA ≤ 25)
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 |
|---|---|---|
| Project 2, Phase 2: Intelligent Adaptive SystemAn innovative intelligent adaptive software package aimed at providing social and cognitive support to older adults with MCI. The system will be designed to adapt to the needs and abilities of the user. | Behavioural | Project 2 - Phase 2: Active Intervention Group, Project 2 - Phase 2: Waitlist Control |
Primary outcome
Project 2, Phase 2: Perceived System Usability of the CAST Program as Measured by the number of times used per day
Time frame: Baseline through 6 months
The CAST system or tablet usability will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, by the number of days used using the sum of times the system was used per day or the average, starting from baseline through six months. Measure is to be developed based on phase 1 of the study.
Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of times the system was used per day
Time frame: Baseline through 6 months
The CAST system or tablet usability will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, using the sum of times the system was used per day or the average starting from baseline through six months. Measure is to be developed based on phase 1 of the study.
Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of features used per day
Time frame: Baseline through 6 months
The CAST system or tablet usability will be assessed by evaluating participants' perception of the features of the system. Real time measures of the CAST system or tablet use will be evaluated, by number of features used per day, using the sum of numbers of features used per day or the average starting from baseline through six months. Measure is to be developed based on phase 1 of the study.
Project 2, Phase 2: Perceived Ease of Use of the CAST Program, assessed using the Perceived Ease of Use Questionnaire
Time frame: 6 months post intervention
Utilizing a 12-item scale (Perceived Ease of Use Questionnaire) which includes two subscales (perceived usefulness and perceived ease of use) with Likert response scales ranging from. 1 (Strongly disagree) - 10 (Strongly agree). The responses to the items are summed for each of the subscales. To assess ease of use, the investigators will evaluate responses to the perceived ease of use subscale.
Project 2, Phase 2: Perceived System Usefulness of the CAST Program, assessed using the Perceived Usefulness Questionnaire
Time frame: 6-months post intervention
Will assess participants' perception of technology-based intervention usefulness. Utilizing a 12-item scale (Perceived Usefulness Questionnaire) which includes two subscales (perceived usefulness and perceived ease of use) with Likert response scales ranging from. 0 (Strongly disagree) - 4 (Strongly agree). Higher sores indicate perceived ease of use of the CAST program. The responses to the items are summed for each of the subscales.
Project 2, Phase 2: Mean scores of participants' perception of CAST program usability and usefulness, assessed using the Usability Metric for user Experience (UMUX-Lite) questionnaire
Time frame: 6-months post intervention
Will assess participants' perception of technology-based intervention ease of use and usefulness. The Usability Metric for User Experience (UMUX-Lite) is a two-item Likert scale used for the subjective assessment of an application's perceived usability. On a 7- point scale, with 0 being strongly disagree and 6 being strongly agree, higher scores are reflective of a greater satisfaction with the system. The scoring range is from 0 to 14. A higher accumulated score is representative of a higher perception of usability.
5 secondary outcomes
Project 2, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure
Time frame: Baseline and 6 month post intervention
Project 2, Phase 2: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire
Time frame: Baseline and 6 month post intervention
Project 2, Phase 2: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale
Time frame: Baseline and 6 month post intervention
Project 2, Phase 2: Mean Difference in score of participants self-reported health, assessed using the 36-Item Short Form Health Survey questionnaire (SF-36 Short Form)
Time frame: Baseline and 6 month post intervention
Project 2, Phase 2: Mean Difference in scores of participants' perceived memory function, assessed using the Perception of Memory Function questionnaire
Time frame: Baseline and 6 month post intervention
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 Aug 2026.
- Individual participant dataSharing planned: Yes. The investigators plan for resource sharing is based on the National Institutes of Health/National Institute on Aging (NIH/NIA) Data Sharing Policy. The investigators plan, consistent with the NIH goals of data sharing, is to promote use of the rich CREATE database by the larger research community as this will further the impact of CREATE and expand possibilities for collaboration. It will also allow other researchers to expedite the translation of the research findings into knowledge, products, and procedures. Further, the plan is devised to make the data as widely and freely available as possible while at the same time safeguarding the privacy of participants and protecting confidential and proprietary data.
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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.
Sara J Czaja, PhD principal investigator
Weill Medical College of Cornell University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project 2, Phase 2: Intelligent Adaptive System in people with Mild Cognitive Impairment, run by Weill Medical College of Cornell University at 3 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 12 inclusion and 5 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 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 3 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?
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 Chelsie Burchett, PhD (646-962-7141, cob2014@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Project 2, Phase 2: Perceived System Usability of the CAST Program as Measured by the number of times used per day (time frame: Baseline through 6 months). The study lists 6 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 17 Aug 2026.