Cognitive HealthSAGENCT05128396
Successful Aging and Enrichment (SAGE)
A study testing Cognitive Stimulation, Mindfulness training and Physical Activity in people with Cognitive Health and Healthy Aging, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Progress has been made in understanding the impact of different kinds of structured intervention programs in improving cognitive processing and performance in older adults, and in determining whether there is electrophysiological evidence for neuroplasticity in individuals over the age of 65. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Health, Healthy Aging
- What is being tested?
- Cognitive Stimulation, Mindfulness training and Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2026
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Be 65 or older
- Have ≥ 8 years of education
- Be sufficiently fluent in the English language to understand instructions and perform the neuropsychological tests (as the purpose of the project is to study healthy aging)
- Score above levels indicating possible cognitive impairment on the Mini Mental State Exam (MMSE) (≥ 26)
- Have an estimated intelligence quotient (IQ) score ≥ 90 based on the American National Reading Test (AmNART)
- Have a score within 2 standard deviations (SD) of the age-appropriate mean on the short form of the Boston Naming Test
- Have a score within 2 SD of the age-appropriate mean on the Logical Memory Subtest of the Wechsler Memory Scale-Third Edition
Who cannot join
- History of Central Nervous System (CNS) diseases or major psychiatric disorders based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
- Score of greater than 10 on the Geriatric Depression Scale
- Corrected visual acuity worse than 20-50 as tested by a Snellen wall chart
- Severe hearing disability that would interfere with their ability to participate in the experiments (e.g., to hear instructions and participate in cognitive testing)
- Medical conditions (e.g., heart or pulmonary disease) that would prevent them from participating in the physical exercise training program
- Evidence of substantial functional decline based on interview questions and completion of a questionnaire based on the Clinical Dementia Rating Scale by an informant who knows the subject well
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Successful Aging and Enrichment (SAGE): Effects of Environmental Stimulation on Cognitive Health and Neuroplasticity
Progress has been made in understanding the impact of different kinds of structured intervention programs in improving cognitive processing and performance in older adults, and in determining whether there is electrophysiological evidence for neuroplasticity in individuals over the age of 65.
Read the detailed description
Study Procedures
Pre-Intervention Assessment The initial screening evaluation will take place over two half-day sessions, each lasting 3 to 3.5 hours in a designated room in the Laboratory of Healthy Cognitive Aging, Center for Brain/Mind Medicine, Brigham and Women's Hospital (BWH), 221 Longwood Avenue, Boston, Massachusetts (MA).
The sessions can be completed over one or two days, depending on the subject's preference.
Pre-Intervention Assessment Session 1 The first session will include completion of informed consent, a medical history, demographic information, including socioeconomic status (SES), survey questionnaires, and tests of visual acuity.
Screening Evaluation (for inclusion/exclusion)
Cognitive Screen
- The Mini-Mental State Examination (MMSE), a broad cognitive test on memory, spatial ability, memory and orientation, commonly used to screen for cognitive impairment
- American National Adult Reading Test (AmNART), a test of word pronunciation that provides an estimated IQ
- Logical Memory I and II, Wechsler Memory Scale-Third Edition, a test of verbal memory
- Boston Naming Test (Short-form, 15-items), a test of confrontation naming.
Depression Screen Geriatric Depression Scale
Neurological/Physical Evaluation Subjects will undergo a structured neurological examination. Height and weight will be obtained to calculate BMI. Visual acuity will be measured (Snellen wall chart).
Gait
Gait will be assessed through a procedure in which subjects walk 10 meters under two conditions:
- Single task (walking at a comfortable pace)
- Dual task (walking at a comfortable pace while simultaneously counting backwards by 3's, beginning with a 3 digit number told to the subject)
Every trial involving serial 3's will start from a different three digit number to reduce learning effects.
Subjects will be given an opportunity to carry out an untimed practice trial. Under the dual task condition, subjects will be instructed to perform as well as possible on both tasks (i.e., no specified prioritization). Each condition will be done 2 times, with the order counterbalanced across subjects. The first and last meter (gait start up and slow down) will not be counted in the measurements.
Time to walk 8 meters and number of steps taken will be measured. Under the dual task, investigators will also track how many numbers are generated while carrying out the serial 3's task (both correct and incorrect responses). In addition, the single task of counting backwards by 3's for 20 seconds will be tested twice in a seated position (once prior to and once after the gait testing).
Informant Questionnaire Subjects will select someone who knows them well (family member or friend) to complete a set of questionnaires. One questionnaire will provide information about a person's level of functioning (based on the Clinical Dementia Rating Scale), and another will inquire about a person's level of engagement (Apathy Scale). e questionnaires will be enclosed with a letter explaining how to complete the forms. The investigators will provide a stamped, addressed envelope to return the questionnaires to us. A backup plan will be to mail these materials directly to the informant selected. This would occur if the materials were misplaced or if the subject requests us to do so.
- Conditions
- Cognitive Health, Healthy Aging
- Being tested
- Cognitive Stimulation, Mindfulness training, Physical Activity, Control Group
- Keywords
- aging, physical activity, cognitive stimulation, neural plasticity, mindfulness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive StimulationBehavioural
During the initial session, a member of the research team will visit the subject's home and introduce the subject to the Cogmed training program (www.cogmed.com). Individuals will start at the same low difficulty level. As training proceeds, task difficulty will be individually adjusted based on performance by increasing/decreasing the number of items individuals have to remember, such that a participant reaches approximately 60% correct per day for each task. Each training session will start at the task difficulty level where the participant ended in the previous session. Performance and reaction time data will be continuously recorded while subjects are doing the task, and these data will be sent via the internet to the research team after each session. A member of the research team will communicate with each subject on a weekly basis (via phone call or email) to provide feedback and address any questions or concerns.
Mindfulness trainingBehavioural
The mindfulness meditations will be narrated by one guide and the tasks will be narrated by a different guide. We will have 7 mindfulness tasks in total, whose order of presentation will be counterbalanced across sessions: 1. mindful observing of place, 2. mindful eating, 3. mindful observing of object, 4. mindful observing of person, 5. mindful walking, 6. mindful listening, and 7. mindful writing with the non-dominant and dominant hand.
At the end of each session, participants will write brief reflections stored via the website (e.g., an estimate of the amount of time subjects experienced their thoughts as wandering) both as an integral part of the mindfulness process and as a means of increasing the likelihood that subjects fully participate in each session. Each session will be structured as follows: Login, Mindfulness Meditation Session, Mindfulness Task 1, Mindfulness Task 2, Mindfulness Task 3, Write Log Reflection, Logout.
Physical ActivityBehavioural
Aerobic exercises will include relatively low impact activities like walking, jogging, or running in place, which will aim to put limited demands on balance. Each exercise will be explained and demonstrated in the video. All exercises can be done standing, sitting, or next to a chair that provides balance support as demonstrated in the videos. After the first session, for each subsequent session the difficulty level will start at one level below the previous session's average difficulty level (e.g. if they exercise at the most difficult level for most of the time during one session, the next session will start at the medium difficulty level). Each exercise will be explained and demonstrated in the video.
Control GroupBehavioural
Individuals in the control group will participate in the same computerized Cogmed training program as described above. The main difference is that for the control group task difficulty will remain at the same low starting level, rather than increasing over time. The instructions given to subjects will be identical to the ones used in the cognitive training intervention.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training using Cogmed | Active comparator | Subjects will complete computerized cognitive training with varying degrees of difficulty over 5 weeks. Receives: Behavioral: Cognitive Stimulation |
| Awareness (mindfulness) training | Active comparator | Subject participate in mindfulness training. The meditation and tasks will become increasingly more self-directed over the 5 weeks; the degree of guidance will decrease to keep the subjective effort approximately constant and moderately challenging through the 5 weeks. Receives: Behavioral: Mindfulness training |
| Physical Exercise Training Using an Interactive Video Platform | Active comparator | Subjects will participate in a structured physical exercise training program that aims to progressively increase their level of activity over the 5 week training period. Receives: Behavioral: Physical Activity |
| Low Level of Cognitive Training Using the Cogmed Program | Placebo comparator | Subjects will complete the same computerized training as the active cognitive arm over the course of 5 weeks, but the main difference is that for the control group task difficulty will remain at the same low starting level, rather than increasing over time. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized assessment of cognitive functions
- CANTAB Paired Associate Learning (PAL) - assesses visual memory and new learning
- CANTAB Attention Switching Task (AST) - measures cued attentional set-shifting
- CANTAB Reaction Time (RTI) - measures speed of response to visual target when the stimulus is either predictable (simple RT) or unpredictable (choice RT)
- CANTAB Spatial Span (SSP) - assesses working memory
- CANTAB One Touch Stockings of Cambridge (OTS) - a test of non-verbal reasoning
Measured: Baseline
Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized assessment of cognitive functions
- CANTAB Paired Associate Learning (PAL) - assesses visual memory and new learning
- CANTAB Attention Switching Task (AST) - measures cued attentional set-shifting
- CANTAB Reaction Time (RTI) - measures speed of response to visual target when the stimulus is either predictable (simple RT) or unpredictable (choice RT)
- CANTAB Spatial Span (SSP) - assesses working memory
- CANTAB One Touch Stockings of Cambridge (OTS) - a test of non-verbal reasoning
Measured: End of Study - 5 weeks post-baseline
Trail Making Test A
Tests of visual attention and task switching Timed task - Max time allotted: 150 seconds
Measured: Baseline
Trail Making Test A
Tests of visual attention and task switching Timed task - Max time allotted: 150 seconds
Measured: End of Study - 5 weeks post-baseline
Trail Making Test B
Tests of visual attention and task switching Timed task - Max time allotted: 300 seconds
Measured: Baseline
Trail Making Test B
Tests of visual attention and task switching Timed - Max time allotted: 300 seconds
Measured: End of Study - 5 weeks post-baseline
Digit Symbol Coding, Weschler Adult Intelligence Scale (WAIS-IV)
A test of processing speed 90 seconds allowed - Higher scores indicate faster processing speed Maximum Score: 91 Minimum Score: 0
Measured: Baseline
Digit Symbol Coding, Weschler Adult Intelligence Scale (WAIS-IV)
A test of processing speed 90 seconds allowed - Higher scores indicate faster processing speed Maximum Score: 91 Minimum Score: 0
Measured: End of Study - 5 weeks post-baseline
Controlled Oral Word Association Test (COWAT)
A test of verbal retrieval and word generation Total score is measured by calculating the total number of acceptable words produced for all three letters.
Measured: Baseline
Controlled Oral Word Association Test (COWAT)
A test of verbal retrieval and word generation Total score is measured by calculating the total number of acceptable words produced for all three letters
Measured: End of Study - 5 weeks post-baseline
Categorical Fluency
A test of rapid retrieval of semantic knowledge Scored by counting the number of correct unique semantic category items produced
Measured: Baseline
Categorical Fluency
A test of rapid retrieval of semantic knowledge Scored by counting the number of correct unique semantic category items produced
Measured: End of study - 5 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cognitive HealthStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Linnaeus University
- Responsible party
- Principal investigator, Kirk Daffner, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128396
- Sponsor's protocol ID
- 2013P002266
- Acronym
- SAGE
- Status last verified
- Nov 2025
- First submitted
- 28 Oct 2021
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feng NC, Ryan E, Kidane M, Tusch ES, McFeeley BM, Carlsson R, Mohammed AH, Hakansson K, Daffner KR. Feasibility of an at-home, web-based, interactive exercise program for older adults. Alzheimers Dement (N Y). 2019 Nov 22;5:825-833. doi: 10.1016/j.trci.2019.10.005. eCollection 2019.
PubMed 31799367Ledreux A, Hakansson K, Carlsson R, Kidane M, Columbo L, Terjestam Y, Ryan E, Tusch E, Winblad B, Daffner K, Granholm AC, Mohammed AKH. Differential Effects of Physical Exercise, Cognitive Training, and Mindfulness Practice on Serum BDNF Levels in Healthy Older Adults: A Randomized Controlled Intervention Study. J Alzheimers Dis. 2019;71(4):1245-1261. doi: 10.3233/JAD-190756.
PubMed 31498125Simon SS, Tusch ES, Feng NC, Hakansson K, Mohammed AH, Daffner KR. Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial. J Alzheimers Dis. 2018;65(3):931-949. doi: 10.3233/JAD-180455.
PubMed 30103334Tusch ES, Alperin BR, Ryan E, Holcomb PJ, Mohammed AH, Daffner KR. Changes in Neural Activity Underlying Working Memory after Computerized Cognitive Training in Older Adults. Front Aging Neurosci. 2016 Nov 8;8:255. doi: 10.3389/fnagi.2016.00255. eCollection 2016.
PubMed 27877122Hakansson K, Ledreux A, Daffner K, Terjestam Y, Bergman P, Carlsson R, Kivipelto M, Winblad B, Granholm AC, Mohammed AK. BDNF Responses in Healthy Older Persons to 35 Minutes of Physical Exercise, Cognitive Training, and Mindfulness: Associations with Working Memory Function. J Alzheimers Dis. 2017;55(2):645-657. doi: 10.3233/JAD-160593.
PubMed 27716670Simon SS, Tusch ES, Holcomb PJ, Daffner KR. Increasing Working Memory Load Reduces Processing of Cross-Modal Task-Irrelevant Stimuli Even after Controlling for Task Difficulty and Executive Capacity. Front Hum Neurosci. 2016 Aug 3;10:380. doi: 10.3389/fnhum.2016.00380. eCollection 2016.
PubMed 27536226
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Successful Aging and Enrichment (SAGE): Effects of Environmental Stimulation on Cognitive Health and Neuroplasticity
- ClinicalTrials.gov ID
- NCT05128396
- Acronym / sponsor ID
- SAGE / 2013P002266
- Conditions
- Cognitive Health, Healthy Aging
- Keywords
- aging, physical activity, cognitive stimulation, neural plasticity, mindfulness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Linnaeus University
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Nov 2021 (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.
Progress has been made in understanding the impact of different kinds of structured intervention programs in improving cognitive processing and performance in older adults, and in determining whether there is electrophysiological evidence for neuroplasticity in individuals over the age of 65.
Detailed description
Study Procedures
Pre-Intervention Assessment The initial screening evaluation will take place over two half-day sessions, each lasting 3 to 3.5 hours in a designated room in the Laboratory of Healthy Cognitive Aging, Center for Brain/Mind Medicine, Brigham and Women's Hospital (BWH), 221 Longwood Avenue, Boston, Massachusetts (MA).
The sessions can be completed over one or two days, depending on the subject's preference.
Pre-Intervention Assessment Session 1 The first session will include completion of informed consent, a medical history, demographic information, including socioeconomic status (SES), survey questionnaires, and tests of visual acuity.
Screening Evaluation (for inclusion/exclusion)
Cognitive Screen
- The Mini-Mental State Examination (MMSE), a broad cognitive test on memory, spatial ability, memory and orientation, commonly used to screen for cognitive impairment
- American National Adult Reading Test (AmNART), a test of word pronunciation that provides an estimated IQ
- Logical Memory I and II, Wechsler Memory Scale-Third Edition, a test of verbal memory
- Boston Naming Test (Short-form, 15-items), a test of confrontation naming.
Depression Screen Geriatric Depression Scale
Neurological/Physical Evaluation Subjects will undergo a structured neurological examination. Height and weight will be obtained to calculate BMI. Visual acuity will be measured (Snellen wall chart).
Gait
Gait will be assessed through a procedure in which subjects walk 10 meters under two conditions:
- Single task (walking at a comfortable pace)
- Dual task (walking at a comfortable pace while simultaneously counting backwards by 3's, beginning with a 3 digit number told to the subject)
Every trial involving serial 3's will start from a different three digit number to reduce learning effects.
Subjects will be given an opportunity to carry out an untimed practice trial. Under the dual task condition, subjects will be instructed to perform as well as possible on both tasks (i.e., no specified prioritization). Each condition will be done 2 times, with the order counterbalanced across subjects. The first and last meter (gait start up and slow down) will not be counted in the measurements.
Time to walk 8 meters and number of steps taken will be measured. Under the dual task, investigators will also track how many numbers are generated while carrying out the serial 3's task (both correct and incorrect responses). In addition, the single task of counting backwards by 3's for 20 seconds will be tested twice in a seated position (once prior to and once after the gait testing).
Informant Questionnaire Subjects will select someone who knows them well (family member or friend) to complete a set of questionnaires. One questionnaire will provide information about a person's level of functioning (based on the Clinical Dementia Rating Scale), and another will inquire about a person's level of engagement (Apathy Scale). e questionnaires will be enclosed with a letter explaining how to complete the forms. The investigators will provide a stamped, addressed envelope to return the questionnaires to us. A backup plan will be to mail these materials directly to the informant selected. This would occur if the materials were misplaced or if the subject requests us to do so.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training using Cogmed | Active comparator | Behavioral: Cognitive StimulationSubjects will complete computerized cognitive training with varying degrees of difficulty over 5 weeks. |
| Awareness (mindfulness) training | Active comparator | Behavioral: Mindfulness trainingSubject participate in mindfulness training. The meditation and tasks will become increasingly more self-directed over the 5 weeks; the degree of guidance will decrease to keep the subjective effort approximately constant and moderately challenging through the 5 weeks. |
| Physical Exercise Training Using an Interactive Video Platform | Active comparator | Behavioral: Physical ActivitySubjects will participate in a structured physical exercise training program that aims to progressively increase their level of activity over the 5 week training period. |
| Low Level of Cognitive Training Using the Cogmed Program | Placebo comparator | Behavioral: Control GroupSubjects will complete the same computerized training as the active cognitive arm over the course of 5 weeks, but the main difference is that for the control group task difficulty will remain at the same low starting level, rather than increasing over time. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Be 65 or older
- Have ≥ 8 years of education
- Be sufficiently fluent in the English language to understand instructions and perform the neuropsychological tests (as the purpose of the project is to study healthy aging)
- Score above levels indicating possible cognitive impairment on the Mini Mental State Exam (MMSE) (≥ 26)
- Have an estimated intelligence quotient (IQ) score ≥ 90 based on the American National Reading Test (AmNART)
Key exclusion criteria (6 listed)
- History of Central Nervous System (CNS) diseases or major psychiatric disorders based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
- Score of greater than 10 on the Geriatric Depression Scale
- Corrected visual acuity worse than 20-50 as tested by a Snellen wall chart
- Severe hearing disability that would interfere with their ability to participate in the experiments (e.g., to hear instructions and participate in cognitive testing)
- Medical conditions (e.g., heart or pulmonary disease) that would prevent them from participating in the physical exercise training program
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 StimulationDuring the initial session, a member of the research team will visit the subject's home and introduce the subject to the Cogmed training program (www.cogmed.com). Individuals will start at the same low difficulty level. As training proceeds, task difficulty will be individually adjusted based on performance by increasing/decreasing the number of items individuals have to remember, such that a participant reaches approximately 60% correct per day for each task. Each training session will start at the task difficulty level where the participant ended in the previous session. Performance and reaction time data will be continuously recorded while subjects are doing the task, and these data will be sent via the internet to the research team after each session. A member of the research team will communicate with each subject on a weekly basis (via phone call or email) to provide feedback and address any questions or concerns. | Behavioural | Cognitive Training using Cogmed |
| Mindfulness trainingThe mindfulness meditations will be narrated by one guide and the tasks will be narrated by a different guide. We will have 7 mindfulness tasks in total, whose order of presentation will be counterbalanced across sessions: 1. mindful observing of place, 2. mindful eating, 3. mindful observing of object, 4. mindful observing of person, 5. mindful walking, 6. mindful listening, and 7. mindful writing with the non-dominant and dominant hand. At the end of each session, participants will write brief reflections stored via the website (e.g., an estimate of the amount of time subjects experienced their thoughts as wandering) both as an integral part of the mindfulness process and as a means of increasing the likelihood that subjects fully participate in each session. Each session will be structured as follows: Login, Mindfulness Meditation Session, Mindfulness Task 1, Mindfulness Task 2, Mindfulness Task 3, Write Log Reflection, Logout. | Behavioural | Awareness (mindfulness) training |
| Physical ActivityAerobic exercises will include relatively low impact activities like walking, jogging, or running in place, which will aim to put limited demands on balance. Each exercise will be explained and demonstrated in the video. All exercises can be done standing, sitting, or next to a chair that provides balance support as demonstrated in the videos. After the first session, for each subsequent session the difficulty level will start at one level below the previous session's average difficulty level (e.g. if they exercise at the most difficult level for most of the time during one session, the next session will start at the medium difficulty level). Each exercise will be explained and demonstrated in the video. | Behavioural | Physical Exercise Training Using an Interactive Video Platform |
| Control GroupIndividuals in the control group will participate in the same computerized Cogmed training program as described above. The main difference is that for the control group task difficulty will remain at the same low starting level, rather than increasing over time. The instructions given to subjects will be identical to the ones used in the cognitive training intervention. | Behavioural | Low Level of Cognitive Training Using the Cogmed Program |
Primary outcome
Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized assessment of cognitive functions
Time frame: Baseline
* CANTAB Paired Associate Learning (PAL) - assesses visual memory and new learning * CANTAB Attention Switching Task (AST) - measures cued attentional set-shifting * CANTAB Reaction Time (RTI) - measures speed of response to visual target when the stimulus is either predictable (simple RT) or unpredictable (choice RT) * CANTAB Spatial Span (SSP) - assesses working memory * CANTAB One Touch Stockings of Cambridge (OTS) - a test of non-verbal reasoning
Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized assessment of cognitive functions
Time frame: End of Study - 5 weeks post-baseline
* CANTAB Paired Associate Learning (PAL) - assesses visual memory and new learning * CANTAB Attention Switching Task (AST) - measures cued attentional set-shifting * CANTAB Reaction Time (RTI) - measures speed of response to visual target when the stimulus is either predictable (simple RT) or unpredictable (choice RT) * CANTAB Spatial Span (SSP) - assesses working memory * CANTAB One Touch Stockings of Cambridge (OTS) - a test of non-verbal reasoning
Trail Making Test A
Time frame: Baseline
Tests of visual attention and task switching Timed task - Max time allotted: 150 seconds
Trail Making Test A
Time frame: End of Study - 5 weeks post-baseline
Tests of visual attention and task switching Timed task - Max time allotted: 150 seconds
Trail Making Test B
Time frame: Baseline
Tests of visual attention and task switching Timed task - Max time allotted: 300 seconds
Trail Making Test B
Time frame: End of Study - 5 weeks post-baseline
Tests of visual attention and task switching Timed - Max time allotted: 300 seconds
Digit Symbol Coding, Weschler Adult Intelligence Scale (WAIS-IV)
Time frame: Baseline
A test of processing speed 90 seconds allowed - Higher scores indicate faster processing speed Maximum Score: 91 Minimum Score: 0
Digit Symbol Coding, Weschler Adult Intelligence Scale (WAIS-IV)
Time frame: End of Study - 5 weeks post-baseline
A test of processing speed 90 seconds allowed - Higher scores indicate faster processing speed Maximum Score: 91 Minimum Score: 0
Controlled Oral Word Association Test (COWAT)
Time frame: Baseline
A test of verbal retrieval and word generation Total score is measured by calculating the total number of acceptable words produced for all three letters.
Controlled Oral Word Association Test (COWAT)
Time frame: End of Study - 5 weeks post-baseline
A test of verbal retrieval and word generation Total score is measured by calculating the total number of acceptable words produced for all three letters
Categorical Fluency
Time frame: Baseline
A test of rapid retrieval of semantic knowledge Scored by counting the number of correct unique semantic category items produced
Categorical Fluency
Time frame: End of study - 5 weeks post-baseline
A test of rapid retrieval of semantic knowledge Scored by counting the number of correct unique semantic category items produced
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 24 Nov 2025.
- Background: PubMed 31799367Feng NC, Ryan E, Kidane M, Tusch ES, McFeeley BM, Carlsson R, Mohammed AH, Hakansson K, Daffner KR. Feasibility of an at-home, web-based, interactive exercise program for older adults. Alzheimers Dement (N Y). 2019 Nov 22;5:825-833. doi: 10.1016/j.trci.2019.10.005. eCollection 2019.
- Background: PubMed 31498125Ledreux A, Hakansson K, Carlsson R, Kidane M, Columbo L, Terjestam Y, Ryan E, Tusch E, Winblad B, Daffner K, Granholm AC, Mohammed AKH. Differential Effects of Physical Exercise, Cognitive Training, and Mindfulness Practice on Serum BDNF Levels in Healthy Older Adults: A Randomized Controlled Intervention Study. J Alzheimers Dis. 2019;71(4):1245-1261. doi: 10.3233/JAD-190756.
- Background: PubMed 30103334Simon SS, Tusch ES, Feng NC, Hakansson K, Mohammed AH, Daffner KR. Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial. J Alzheimers Dis. 2018;65(3):931-949. doi: 10.3233/JAD-180455.
- Background: PubMed 27877122Tusch ES, Alperin BR, Ryan E, Holcomb PJ, Mohammed AH, Daffner KR. Changes in Neural Activity Underlying Working Memory after Computerized Cognitive Training in Older Adults. Front Aging Neurosci. 2016 Nov 8;8:255. doi: 10.3389/fnagi.2016.00255. eCollection 2016.
- Background: PubMed 27716670Hakansson K, Ledreux A, Daffner K, Terjestam Y, Bergman P, Carlsson R, Kivipelto M, Winblad B, Granholm AC, Mohammed AK. BDNF Responses in Healthy Older Persons to 35 Minutes of Physical Exercise, Cognitive Training, and Mindfulness: Associations with Working Memory Function. J Alzheimers Dis. 2017;55(2):645-657. doi: 10.3233/JAD-160593.
- Background: PubMed 27536226Simon SS, Tusch ES, Holcomb PJ, Daffner KR. Increasing Working Memory Load Reduces Processing of Cross-Modal Task-Irrelevant Stimuli Even after Controlling for Task Difficulty and Executive Capacity. Front Hum Neurosci. 2016 Aug 3;10:380. doi: 10.3389/fnhum.2016.00380. eCollection 2016.
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Longevity Metrics AI/ML Development Study
Aging, Mortality
RecruitingPhase 1/2
Snacks and Brain Health
Cognitive Assessment, Psychological Function
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?
A study testing Cognitive Stimulation, Mindfulness training and Physical Activity in people with Cognitive Health and Healthy Aging, run by Brigham and Women's Hospital 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: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. 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. Some participants in this study may receive a placebo. 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?
Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized assessment of cognitive functions (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05128396, which also lists 6 linked publications.
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 24 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.