Amnestic Mild Cognitive ImpairmentNCT05903573
Training Response Artificial Intelligence Network (TRAIN)
A study testing Cognitive Training and Computerized Cognitive Stimulation in people with Amnestic Mild Cognitive Impairment, run by University of Florida at 1 site in United States.
Trial summary
This study will train a machine learning tool to predict response to a cognitive training intervention using baseline brain MRI sequences from older adults with amnestic mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 55 to 100 years
- Conditions the study is for
- Amnestic Mild Cognitive Impairment
- What is being tested?
- Cognitive Training and Computerized Cognitive Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2023to 30 Apr 2028
- 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 55 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of changed cognition reported by a close informant as obtained by an interview with a licensed clinical psychologist (PI, Gullett)
- Cognitive performance on one or more standardized neuropsychological measures of verbal or non-verbal memory > 1.0 standard deviation or more below the normative mean for age and education
- No evidence of reported dependence in instrumental functional abilities (IADLs) despite reported cognitive difficulties
- No evidence of dementia based on cognitive screening (Montreal Cognitive Assessment Score within normal limits for age, education, and sex using the NACC Uniform Data Set (UDS) norms.
- Global clinical dementia rating scale (CDR) score must be equal to 0.5
- Willingness to be randomized into either the educational training (control) or intervention (cognitive training) group
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- Able and willing to devote 12 weeks to the intervention with additional time for pre- and post-testing
- Able and willing to perform cognitive and emotional measures both on paper and on a tablet computer
- In line with the recommendations of the SCD task force, an informant must be available. This is to a) obtain information about the participant's complaints and cognitive difficulties on interview, and b) to ascertain validity of self-reported IADL function in regard to instrumental functional activities.
Who cannot join
- Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental tasks or neuropsychological assessment
- English as a second language
- Inability to undergo brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable body jewelry, or shrapnel containing ferromagnetic metal
- Previous major strokes or other known significant brain abnormalities or diseases affecting the brain and/or cognition (e.g., Parkinson disease, multiple sclerosis, seizure disorder, brain surgery, moderate TBI, REM Behavior Sleep Disorder, untreated sleep apnea, etc.)
- Unstable and uncontrolled medical conditions (metastatic cancer, HIV, moderate-severe kidney disease, uncontrolled diabetes, uncontrolled hypertension, severe cardiac disease, etc.). No current cancer diagnosis
- Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse or history thereof within the past six months. The investigators are not excluding individuals who are taking antidepressant or anti-anxiety medications, however, use of these medications will be recorded and data analyzed in post-hoc analyses
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- Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
- Use of photo-sensitive medications such as steroids or retin-A within 15 days of the study intervention.
- Previous participation in a cognitive training study within the last 6 months or current involvement in another study involving cognitive, physical or other intervention at the time of participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Artificial Intelligence to Predict Cognitive Training Response in Amnestic Mild Cognitive Impairment
This study will train a machine learning tool to predict response to a cognitive training intervention using baseline brain MRI sequences from older adults with amnestic mild cognitive impairment.
Read the detailed description
This randomized controlled clinical trial proposes to test a well-supported Cognitive Training intervention approach for enhancing cognition in older adults who meet criteria for amnestic mild cognitive impairment (aMCI). The trial will recruit participants recently enrolled in a larger multi-site clinical trial (NCT04171323) at the University of Florida site based on meeting inclusion criteria and willingness to participate in the additional procedures (baseline MRI) required. The intervention will consist of a take-home, iPad-based, adaptive cognitive training (Posit Science Brain HQ Suite) program which participants will be trained to self-administer 2-3 days/week for 60-minutes per session over the course of 16 weeks with a goal of completing 40 training sessions total. Participants randomized to one of four arms of cognitive training or an active control condition. All cognitive training arms will include training on a measure of rapid decision making (Double Decision, similar to the Useful Field of View [UFOV] task) in addition to a combination of other subtests to determine which combination best facilitates cognitive gains.
Outcomes: The investigators plan to test the hypotheses that 1) Compared to the active control condition, CT will result in greater than 1.0SD cognitive improvement on several trained tasks (proximal transfer) and untrained cognitive skills (near transfer) for 20% of the sample, while another 20% will continue to experience cognitive decline equivalent to 1.0SD or greater despite adequate adherence to the intervention, and 2) baseline factors related to cognitive function, brain structure, and resting-state brain function can ultimately predict which individuals will show improvement after the 16-week intervention. These baseline factors will be measured by a well-established neuropsychological battery, the useful field of view (UFOV) task, a detailed set of MRI sequences, and their associations with the outcomes will be determined by a type of machine learning known as multi-modal support vector machine (SVM). This type of analysis will allow the integration of a myriad of data points and MRI features to combine into a highly accurate predictive model for cognitive functioning improvement after intervention. The primary outcome measure that will be predicted by the SVM is the UFOV composite score change, which is a combination of post-minus-pre intervention change across UFOV processing speed, selective attention, and divided attention scores. The secondary outcome measure that will be predicted by the SVM is the Posit Composite score, which is a fixed difficulty assessment of proximal transfer effects of the trained tasks. Assessments will occur at baseline (month 1) and at the end of the 16-week intervention (Month 4). Brain imaging will only be performed at baseline. The primary aim is to further establish the efficacy of this well-supported cognitive training paradigm in a population of patients with amnestic Mild Cognitive Impairment, and the secondary aim is to distinguish intervention responders from non-responders using baseline cognitive, functional-neural, and demographic data alone.
- Conditions
- Amnestic Mild Cognitive Impairment
- Being tested
- Cognitive Training, Computerized Cognitive Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
The intervention group will receive cognitive training that provides specific training tasks directed at essential cognitive domains tied to the project's aims and hypotheses (processing speed and working memory) that correspond with the neurocognitive and functional neuroimaging measures to be studied.
Computerized Cognitive StimulationBehavioural
Participants will complete cognitively-stimulating computer activities. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Cognitive Training | Experimental | Participants will complete computerized cognitive training via Posit Science Brain HQ. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions. Receives: Behavioral: Cognitive Training |
| Active Control Group: Computerized Cognitive Stimulation | Active comparator | Participants will complete cognitively-stimulating computer activities. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions. Receives: Behavioral: Computerized Cognitive Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Useful Field of View Composite
The Useful Field of View (UFOV) composite change score is calculated by subtracting the post-intervention score (0-500) from the pre-intervention score (0-500), where a more negative change score is indicative of stronger improvement after intervention (range +500 to -500).
Measured: Baseline up to week 12 during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start9 Oct 2023
- Primary completion30 May 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amnestic Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Joseph Gullett, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903573
- Sponsor's protocol ID
- IRB202201517
- Other IDs
- K23AG080127
- Status last verified
- Oct 2026
- First submitted
- 6 Jun 2023
- Last updated
- 9 Oct 2026
- Results posted
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Artificial Intelligence to Predict Cognitive Training Response in Amnestic Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05903573
- Acronym / sponsor ID
- IRB202201517
- Conditions
- Amnestic Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 15 Jun 2023 (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.
This study will train a machine learning tool to predict response to a cognitive training intervention using baseline brain MRI sequences from older adults with amnestic mild cognitive impairment.
Detailed description
This randomized controlled clinical trial proposes to test a well-supported Cognitive Training intervention approach for enhancing cognition in older adults who meet criteria for amnestic mild cognitive impairment (aMCI). The trial will recruit participants recently enrolled in a larger multi-site clinical trial (NCT04171323) at the University of Florida site based on meeting inclusion criteria and willingness to participate in the additional procedures (baseline MRI) required. The intervention will consist of a take-home, iPad-based, adaptive cognitive training (Posit Science Brain HQ Suite) program which participants will be trained to self-administer 2-3 days/week for 60-minutes per session over the course of 16 weeks with a goal of completing 40 training sessions total. Participants randomized to one of four arms of cognitive training or an active control condition. All cognitive training arms will include training on a measure of rapid decision making (Double Decision, similar to the Useful Field of View [UFOV] task) in addition to a combination of other subtests to determine which combination best facilitates cognitive gains.
Outcomes: The investigators plan to test the hypotheses that 1) Compared to the active control condition, CT will result in greater than 1.0SD cognitive improvement on several trained tasks (proximal transfer) and untrained cognitive skills (near transfer) for 20% of the sample, while another 20% will continue to experience cognitive decline equivalent to 1.0SD or greater despite adequate adherence to the intervention, and 2) baseline factors related to cognitive function, brain structure, and resting-state brain function can ultimately predict which individuals will show improvement after the 16-week intervention. These baseline factors will be measured by a well-established neuropsychological battery, the useful field of view (UFOV) task, a detailed set of MRI sequences, and their associations with the outcomes will be determined by a type of machine learning known as multi-modal support vector machine (SVM). This type of analysis will allow the integration of a myriad of data points and MRI features to combine into a highly accurate predictive model for cognitive functioning improvement after intervention. The primary outcome measure that will be predicted by the SVM is the UFOV composite score change, which is a combination of post-minus-pre intervention change across UFOV processing speed, selective attention, and divided attention scores. The secondary outcome measure that will be predicted by the SVM is the Posit Composite score, which is a fixed difficulty assessment of proximal transfer effects of the trained tasks. Assessments will occur at baseline (month 1) and at the end of the 16-week intervention (Month 4). Brain imaging will only be performed at baseline. The primary aim is to further establish the efficacy of this well-supported cognitive training paradigm in a population of patients with amnestic Mild Cognitive Impairment, and the secondary aim is to distinguish intervention responders from non-responders using baseline cognitive, functional-neural, and demographic data alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Cognitive Training | Experimental | Behavioral: Cognitive TrainingParticipants will complete computerized cognitive training via Posit Science Brain HQ. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions. |
| Active Control Group: Computerized Cognitive Stimulation | Active comparator | Behavioral: Computerized Cognitive StimulationParticipants will complete cognitively-stimulating computer activities. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions. |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Evidence of changed cognition reported by a close informant as obtained by an interview with a licensed clinical psychologist (PI, Gullett)
- Cognitive performance on one or more standardized neuropsychological measures of verbal or non-verbal memory > 1.0 standard deviation or more below the normative mean for age and education
- No evidence of reported dependence in instrumental functional abilities (IADLs) despite reported cognitive difficulties
- No evidence of dementia based on cognitive screening (Montreal Cognitive Assessment Score within normal limits for age, education, and sex using the NACC Uniform Data Set (UDS) norms.
- Global clinical dementia rating scale (CDR) score must be equal to 0.5
Key exclusion criteria (9 listed)
- Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental tasks or neuropsychological assessment
- English as a second language
- Inability to undergo brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable body jewelry, or shrapnel containing ferromagnetic metal
- Previous major strokes or other known significant brain abnormalities or diseases affecting the brain and/or cognition (e.g., Parkinson disease, multiple sclerosis, seizure disorder, brain surgery, moderate TBI, REM Behavior Sleep Disorder, untreated sleep apnea, etc.)
- Unstable and uncontrolled medical conditions (metastatic cancer, HIV, moderate-severe kidney disease, uncontrolled diabetes, uncontrolled hypertension, severe cardiac disease, etc.). No current cancer diagnosis
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 |
|---|---|---|
| Cognitive TrainingThe intervention group will receive cognitive training that provides specific training tasks directed at essential cognitive domains tied to the project's aims and hypotheses (processing speed and working memory) that correspond with the neurocognitive and functional neuroimaging measures to be studied. | Behavioural | Intervention Group: Cognitive Training |
| Computerized Cognitive StimulationParticipants will complete cognitively-stimulating computer activities. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions. | Behavioural | Active Control Group: Computerized Cognitive Stimulation |
Primary outcome
Useful Field of View Composite
Time frame: Baseline up to week 12 during follow-up
The Useful Field of View (UFOV) composite change score is calculated by subtracting the post-intervention score (0-500) from the pre-intervention score (0-500), where a more negative change score is indicative of stronger improvement after intervention (range +500 to -500).
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 9 Oct 2026.
- 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.
Joseph Gullett, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training and Computerized Cognitive Stimulation in people with Amnestic Mild Cognitive Impairment, run by University of Florida 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 9 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 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?
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?
Useful Field of View Composite (time frame: Baseline up to week 12 during follow-up). 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 9 Oct 2026.