Amnestic Mild Cognitive ImpairmentmSIMNCT04185298
mSIM: Mobile Simultaneous Aerobic Exercise and Memory Training Intervention for Amnestic Mild Cognitive Impairment
A study testing mSIM intervention plus activity monitoring and Activity monitoring in people with Amnestic Mild Cognitive Impairment, run by Jennifer Bramen at 1 site in United States.
Trial summary
The mSIM study involves developing and conducting feasibility testing of a web-based application that will deliver mobile-based simultaneous exercise and memory skills training program (mSIM) for amnesic Mild Cognitive Impairment (aMCI) patients. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Amnestic Mild Cognitive Impairment
- What is being tested?
- mSIM intervention plus activity monitoring and Activity monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 17 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be age 50 to 80 at time of informed consent.
- Subjects must confirm an aMCI diagnosis either by providing records from a clinical assessment within 6 months of enrollment in this study or through a brief memory assessment by study staff at screening.
- Subjects must be proficient in spoken and written English for consenting as well as for study participation since the intervention in this study is currently only available in English.
- Subjects with medical conditions must be stable for these conditions. Stable control on medication is acceptable.
- Subjects, with or without assistance, must be able to use a computer and web interface. If assistance is needed, it must be readily available to them.
- Subjects are required to have internet with Wi-Fi at the location of their mSIM training.
Show all 10Show fewer
- Subject must have normal visual acuity (or corrected to normal) and normal color vision as indicated by self-report.
- Subject must have adequate hearing acuity as indicated by self-report.
- Subject must have adequate motor capacity to use a mobile phone/iPad/computer as indicated by self-report.
- Subjects must be able to provide medical clearance to participate in an unsupervised, moderate intensity exercise program from a physician.
Who cannot join
- Subjects must not have an existing diagnosis of a neurodegenerative disorder (e.g., Alzheimer's Disease, Lewy Body Dementia, Frontal-Temporal Dementia).
- Subjects must not have a prior diagnosis that might impact cognition and movement abilities including: significant cardiovascular disease, significant respiratory disease, illness or injury, substance abuse, schizophrenia, bipolar disorder, or other neurological diseases.
- Subjects must not have a previous Mini Mental State Exam (MMSE) score below 19.
- Subjects must not have a previous Clinical Dementia Rating (CDR) global score of ≥2.
- Subjects must not have a Montreal Cognitive Assessment (MoCA)43 score of below 18 previously or during their screening evaluation.
- Subjects must not demonstrate a progression of aMCI to dementia at screening based on the best judgement of a study Clinical Neuropsychologist.
- Subjects must not currently participate in a high level of physical activity prior to study start as assessed by the International Physical Activity Questionnaire (IPAQ) at screening.
- Subjects must not endorse that they are unable to participate in moderate intensity aerobic activities, such as fast walking or passing/kicking a ball to a partner at screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Brain Health Center
Santa Monica, California, 90404
About this study
Official title: Mobile Technology-Based Simultaneous Aerobic Exercise and Memory Training Intervention for Older Adults With Mild Cognitive Impairment
The mSIM study involves developing and conducting feasibility testing of a web-based application that will deliver mobile-based simultaneous exercise and memory skills training program (mSIM) for amnesic Mild Cognitive Impairment (aMCI) patients.
The randomized control trial (RCT) will evaluate the efficacy of mSIM on memory performance and everyday functioning using 2 study arms (Group 1 activity monitoring control (via Fitbit) (CON) vs Group 2 mSIM intervention plus activity monitoring via Fitbit). mSIM treatment response will be evaluated using neuropsychological and functional evaluation. Concentration levels of peripheral biomarkers Brain-derived neurotrophic factor (BDNF) and norepinephrine (NE) also be assessed.
Read the detailed description
The purpose of the study is to create a web-based cognitive compensatory, and predominately memory skills, training course that is delivered on a mobile device and compatible with use on a stationary bicycle and test its efficacy on memory and functional ability.
Participants will be recruited from (1) the Pacific Brain Health Center in Santa Monica, which is a high-volume memory-care and dementia outpatient clinic within a large physician medical group affiliated with Providence Saint John's Health Center, (2) advertisement to participants in the local community, and (3) establishment of a website landing page that permits interested individuals to contact the trial coordinator. Up to five participants will be course beta testers. They will receive a truncated version of the course and will provide detailed feedback. 30 participants will be randomized into one of two groups. Group 1 (control arm) will have their physical activity levels continuously monitored (via Fitbit). Participants will receive the Experimental Research Subject's Bill of Rights prior to signing the informed consent form (ICF), authorization of use and disclosure of protected health information (PHI), and authorization of medical record release for the subject's treating physician, will be obtained from each participant prior to enrolling in the study. A copy of all signed ICF's will be given to the participants, and the investigator will retain the original.
Group 2 (active arm) will receive the mSIM intervention plus activity monitoring (via Fitbit). Group 2 will first undergo 2-6 week of an exercise ramp-up (2x/week) until they can sustain 40 minutes at 50% heart rate reserve (HRR). The intensity for mSIM training will be 40-60% HRR. After the ramp-up phase the mSIM participants will begin the 12-week intervention, comprised of 2 60-minute sessions/week. mSIM treatment response will be evaluated using neuropsychological and functional evaluation. Assessments will occur at baseline, mid-trial (3-4 months) and post-trial (5-6 months). Concentration levels of peripheral biomarkers BDNF and NE at baseline and post-trial (5-6 months) will also be assessed.
- Conditions
- Amnestic Mild Cognitive Impairment
- Being tested
- mSIM intervention plus activity monitoring, Activity monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mSIM intervention plus activity monitoringBehavioural
Participants will receive the full mSIM intervention and be monitored (via Fitbit)
Activity monitoringBehavioural
Participants will have activity monitored (via Fitbit)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (No treatment) | Active comparator | Group 1: Participants will have continuous activity monitoring (via Fitbit) Receives: Behavioral: mSIM intervention plus activity monitoring |
| Group 2 (Experimental) | Experimental | Group 2: Participants will receive the mSIM treatment and have their activity monitored continuously (via Fitbit) Receives: Behavioral: Activity monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory Function Composite Score
Global Z-Score including results from RAVLT (Rey's Auditory Verbal Learning Test), Wechsler Memory Scale Fourth Edition (WMS-IV) Logical Memory and Visual Reproduction tests.
The global z score was constructed by:
First z-transforming all raw test scores (RAVLT, Logical Memory (LM) I Total, LM II Total, Visual Reproduction (VR) I and VR II) Averaging over RAVLT Z, LM Z, and VR Z to obtain a global Z 0=sample mean; higher scores indicate better outcomes.
Measured: Baseline, approximately 3 months and approximately 6 months
Functional Abilities
Assessed using the Multifactorial Memory Questionnaire (MMQ) Satisfaction Sub-scale (0-72 points). Higher scores indicate better outcomes.
Measured: Baseline, approximately 3 months and approximately 6 months
Secondary outcomes (2)
Resting Brain-derived Neurotrophic Factor (BDNF)
Resting level of serum-derived BDNF
Measured: Baseline and approximately 6 months
Resting Norepinephrine (NE)
Resting level of plasma-derived norepinephrine (NE)
Measured: Baseline and approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Oct 2019
- Primary completion17 Apr 2023
- Study completion17 Apr 2023
Why it stopped: Due to difficulties in recruitment and completion rates, the study was considered to be not feasible. After 4 years, only 12 participants were randomized. Of the 8 mSIM arm participants, only 2 completed the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Amnestic Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will include two arms: Arm 1: activity monitoring only control (CON), Arm 2: active intervention with mSIM program (mSIM) plus activity monitoring (via Fitbit), to evaluate the efficacy of the mSIM intervention on memory performance and everyday functioning. The 'Activity monitoring only' arm will serve as the control group. Study objectives include measuring treatment related changes in memory performance and everyday functioning along with putative biomarkers of the behavioral changes.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Bramen
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Jennifer Bramen, Saint John's Cancer Institute
- Investigators
- Jennifer Bramen, PhD, Principal investigator, Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185298
- Sponsor's protocol ID
- 20191298
- Other IDs
- R21AG061494
- Acronym
- mSIM
- Status last verified
- Jan 2025
- First submitted
- 2 Dec 2019
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rozzini L, Chilovi BV, Conti M, Bertoletti E, Delrio I, Trabucchi M, Padovani A. Conversion of amnestic Mild Cognitive Impairment to dementia of Alzheimer type is independent to memory deterioration. Int J Geriatr Psychiatry. 2007 Dec;22(12):1217-22. doi: 10.1002/gps.1816.
PubMed 17562522Naismith SL, Glozier N, Burke D, Carter PE, Scott E, Hickie IB. Early intervention for cognitive decline: is there a role for multiple medical or behavioural interventions? Early Interv Psychiatry. 2009 Feb;3(1):19-27. doi: 10.1111/j.1751-7893.2008.00102.x.
PubMed 21352171Merrill DA, Small GW. Prevention in psychiatry: effects of healthy lifestyle on cognition. Psychiatr Clin North Am. 2011 Mar;34(1):249-61. doi: 10.1016/j.psc.2010.11.009. Epub 2010 Dec 16.
PubMed 21333851Rodakowski J, Saghafi E, Butters MA, Skidmore ER. Non-pharmacological interventions for adults with mild cognitive impairment and early stage dementia: An updated scoping review. Mol Aspects Med. 2015 Jun-Oct;43-44:38-53. doi: 10.1016/j.mam.2015.06.003. Epub 2015 Jun 10.
PubMed 26070444Smith PJ, Blumenthal JA, Hoffman BM, Cooper H, Strauman TA, Welsh-Bohmer K, Browndyke JN, Sherwood A. Aerobic exercise and neurocognitive performance: a meta-analytic review of randomized controlled trials. Psychosom Med. 2010 Apr;72(3):239-52. doi: 10.1097/PSY.0b013e3181d14633. Epub 2010 Mar 11.
PubMed 20223924Sofi F, Valecchi D, Bacci D, Abbate R, Gensini GF, Casini A, Macchi C. Physical activity and risk of cognitive decline: a meta-analysis of prospective studies. J Intern Med. 2011 Jan;269(1):107-17. doi: 10.1111/j.1365-2796.2010.02281.x. Epub 2010 Sep 10.
PubMed 20831630Huckans M, Hutson L, Twamley E, Jak A, Kaye J, Storzbach D. Efficacy of cognitive rehabilitation therapies for mild cognitive impairment (MCI) in older adults: working toward a theoretical model and evidence-based interventions. Neuropsychol Rev. 2013 Mar;23(1):63-80. doi: 10.1007/s11065-013-9230-9. Epub 2013 Mar 8.
PubMed 23471631Snowden M, Steinman L, Mochan K, Grodstein F, Prohaska TR, Thurman DJ, Brown DR, Laditka JN, Soares J, Zweiback DJ, Little D, Anderson LA. Effect of exercise on cognitive performance in community-dwelling older adults: review of intervention trials and recommendations for public health practice and research. J Am Geriatr Soc. 2011 Apr;59(4):704-16. doi: 10.1111/j.1532-5415.2011.03323.x. Epub 2011 Mar 25.
PubMed 21438861Kramer AF, Colcombe S. Fitness Effects on the Cognitive Function of Older Adults: A Meta-Analytic Study-Revisited. Perspect Psychol Sci. 2018 Mar;13(2):213-217. doi: 10.1177/1745691617707316.
PubMed 29592650Bamidis PD, Vivas AB, Styliadis C, Frantzidis C, Klados M, Schlee W, Siountas A, Papageorgiou SG. A review of physical and cognitive interventions in aging. Neurosci Biobehav Rev. 2014 Jul;44:206-20. doi: 10.1016/j.neubiorev.2014.03.019. Epub 2014 Apr 4.
PubMed 24705268Zhu X, Yin S, Lang M, He R, Li J. The more the better? A meta-analysis on effects of combined cognitive and physical intervention on cognition in healthy older adults. Ageing Res Rev. 2016 Nov;31:67-79. doi: 10.1016/j.arr.2016.07.003. Epub 2016 Jul 14.
PubMed 27423932Law LL, Barnett F, Yau MK, Gray MA. Effects of combined cognitive and exercise interventions on cognition in older adults with and without cognitive impairment: a systematic review. Ageing Res Rev. 2014 May;15:61-75. doi: 10.1016/j.arr.2014.02.008. Epub 2014 Mar 12.
PubMed 24632497Karssemeijer EGA, Aaronson JA, Bossers WJ, Smits T, Olde Rikkert MGM, Kessels RPC. Positive effects of combined cognitive and physical exercise training on cognitive function in older adults with mild cognitive impairment or dementia: A meta-analysis. Ageing Res Rev. 2017 Nov;40:75-83. doi: 10.1016/j.arr.2017.09.003. Epub 2017 Sep 12.
PubMed 28912076McEwen SC, Siddarth P, Rahi B, Kim Y, Mui W, Wu P, Emerson ND, Lee J, Greenberg S, Shelton T, Kaiser S, Small GW, Merrill DA. Simultaneous Aerobic Exercise and Memory Training Program in Older Adults with Subjective Memory Impairments. J Alzheimers Dis. 2018;62(2):795-806. doi: 10.3233/JAD-170846.
PubMed 29480182Black JE, Isaacs KR, Anderson BJ, Alcantara AA, Greenough WT. Learning causes synaptogenesis, whereas motor activity causes angiogenesis, in cerebellar cortex of adult rats. Proc Natl Acad Sci U S A. 1990 Jul;87(14):5568-72. doi: 10.1073/pnas.87.14.5568.
PubMed 1695380
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Technology-Based Simultaneous Aerobic Exercise and Memory Training Intervention for Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04185298
- Acronym / sponsor ID
- mSIM / 20191298
- Conditions
- Amnestic Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to difficulties in recruitment and completion rates, the study was considered to be not feasible. After 4 years, only 12 participants were randomized. Of the 8 mSIM arm participants, only 2 completed the study.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jennifer BramenUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The mSIM study involves developing and conducting feasibility testing of a web-based application that will deliver mobile-based simultaneous exercise and memory skills training program (mSIM) for amnesic Mild Cognitive Impairment (aMCI) patients.
The randomized control trial (RCT) will evaluate the efficacy of mSIM on memory performance and everyday functioning using 2 study arms (Group 1 activity monitoring control (via Fitbit) (CON) vs Group 2 mSIM intervention plus activity monitoring via Fitbit). mSIM treatment response will be evaluated using neuropsychological and functional evaluation. Concentration levels of peripheral biomarkers Brain-derived neurotrophic factor (BDNF) and norepinephrine (NE) also be assessed.
Detailed description
The purpose of the study is to create a web-based cognitive compensatory, and predominately memory skills, training course that is delivered on a mobile device and compatible with use on a stationary bicycle and test its efficacy on memory and functional ability.
Participants will be recruited from (1) the Pacific Brain Health Center in Santa Monica, which is a high-volume memory-care and dementia outpatient clinic within a large physician medical group affiliated with Providence Saint John's Health Center, (2) advertisement to participants in the local community, and (3) establishment of a website landing page that permits interested individuals to contact the trial coordinator. Up to five participants will be course beta testers. They will receive a truncated version of the course and will provide detailed feedback. 30 participants will be randomized into one of two groups. Group 1 (control arm) will have their physical activity levels continuously monitored (via Fitbit). Participants will receive the Experimental Research Subject's Bill of Rights prior to signing the informed consent form (ICF), authorization of use and disclosure of protected health information (PHI), and authorization of medical record release for the subject's treating physician, will be obtained from each participant prior to enrolling in the study. A copy of all signed ICF's will be given to the participants, and the investigator will retain the original.
Group 2 (active arm) will receive the mSIM intervention plus activity monitoring (via Fitbit). Group 2 will first undergo 2-6 week of an exercise ramp-up (2x/week) until they can sustain 40 minutes at 50% heart rate reserve (HRR). The intensity for mSIM training will be 40-60% HRR. After the ramp-up phase the mSIM participants will begin the 12-week intervention, comprised of 2 60-minute sessions/week. mSIM treatment response will be evaluated using neuropsychological and functional evaluation. Assessments will occur at baseline, mid-trial (3-4 months) and post-trial (5-6 months). Concentration levels of peripheral biomarkers BDNF and NE at baseline and post-trial (5-6 months) will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will include two arms: Arm 1: activity monitoring only control (CON), Arm 2: active intervention with mSIM program (mSIM) plus activity monitoring (via Fitbit), to evaluate the efficacy of the mSIM intervention on memory performance and everyday functioning. The 'Activity monitoring only' arm will serve as the control group. Study objectives include measuring treatment related changes in memory performance and everyday functioning along with putative biomarkers of the behavioral changes.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (No treatment) | Active comparator | Behavioral: mSIM intervention plus activity monitoringGroup 1: Participants will have continuous activity monitoring (via Fitbit) |
| Group 2 (Experimental) | Experimental | Behavioral: Activity monitoringGroup 2: Participants will receive the mSIM treatment and have their activity monitored continuously (via Fitbit) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must be age 50 to 80 at time of informed consent.
- Subjects must confirm an aMCI diagnosis either by providing records from a clinical assessment within 6 months of enrollment in this study or through a brief memory assessment by study staff at screening.
- Subjects must be proficient in spoken and written English for consenting as well as for study participation since the intervention in this study is currently only available in English.
- Subjects with medical conditions must be stable for these conditions. Stable control on medication is acceptable.
- Subjects, with or without assistance, must be able to use a computer and web interface. If assistance is needed, it must be readily available to them.
Key exclusion criteria (8 listed)
- Subjects must not have an existing diagnosis of a neurodegenerative disorder (e.g., Alzheimer's Disease, Lewy Body Dementia, Frontal-Temporal Dementia).
- Subjects must not have a prior diagnosis that might impact cognition and movement abilities including: significant cardiovascular disease, significant respiratory disease, illness or injury, substance abuse, schizophrenia, bipolar disorder, or other neurological diseases.
- Subjects must not have a previous Mini Mental State Exam (MMSE) score below 19.
- Subjects must not have a previous Clinical Dementia Rating (CDR) global score of ≥2.
- Subjects must not have a Montreal Cognitive Assessment (MoCA)43 score of below 18 previously or during their screening evaluation.
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 |
|---|---|---|
| mSIM intervention plus activity monitoringParticipants will receive the full mSIM intervention and be monitored (via Fitbit) | Behavioural | Group 1 (No treatment) |
| Activity monitoringParticipants will have activity monitored (via Fitbit) | Behavioural | Group 2 (Experimental) |
Primary outcome
Memory Function Composite Score
Time frame: Baseline, approximately 3 months and approximately 6 months
Global Z-Score including results from RAVLT (Rey's Auditory Verbal Learning Test), Wechsler Memory Scale Fourth Edition (WMS-IV) Logical Memory and Visual Reproduction tests. The global z score was constructed by: First z-transforming all raw test scores (RAVLT, Logical Memory (LM) I Total, LM II Total, Visual Reproduction (VR) I and VR II) Averaging over RAVLT Z, LM Z, and VR Z to obtain a global Z 0=sample mean; higher scores indicate better outcomes.
Functional Abilities
Time frame: Baseline, approximately 3 months and approximately 6 months
Assessed using the Multifactorial Memory Questionnaire (MMQ) Satisfaction Sub-scale (0-72 points). Higher scores indicate better outcomes.
2 secondary outcomes
Resting Brain-derived Neurotrophic Factor (BDNF)
Time frame: Baseline and approximately 6 months
Resting Norepinephrine (NE)
Time frame: Baseline and approximately 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17562522Rozzini L, Chilovi BV, Conti M, Bertoletti E, Delrio I, Trabucchi M, Padovani A. Conversion of amnestic Mild Cognitive Impairment to dementia of Alzheimer type is independent to memory deterioration. Int J Geriatr Psychiatry. 2007 Dec;22(12):1217-22. doi: 10.1002/gps.1816.
- Background: PubMed 21352171Naismith SL, Glozier N, Burke D, Carter PE, Scott E, Hickie IB. Early intervention for cognitive decline: is there a role for multiple medical or behavioural interventions? Early Interv Psychiatry. 2009 Feb;3(1):19-27. doi: 10.1111/j.1751-7893.2008.00102.x.
- Background: PubMed 21333851Merrill DA, Small GW. Prevention in psychiatry: effects of healthy lifestyle on cognition. Psychiatr Clin North Am. 2011 Mar;34(1):249-61. doi: 10.1016/j.psc.2010.11.009. Epub 2010 Dec 16.
- Background: PubMed 26070444Rodakowski J, Saghafi E, Butters MA, Skidmore ER. Non-pharmacological interventions for adults with mild cognitive impairment and early stage dementia: An updated scoping review. Mol Aspects Med. 2015 Jun-Oct;43-44:38-53. doi: 10.1016/j.mam.2015.06.003. Epub 2015 Jun 10.
- Background: PubMed 20223924Smith PJ, Blumenthal JA, Hoffman BM, Cooper H, Strauman TA, Welsh-Bohmer K, Browndyke JN, Sherwood A. Aerobic exercise and neurocognitive performance: a meta-analytic review of randomized controlled trials. Psychosom Med. 2010 Apr;72(3):239-52. doi: 10.1097/PSY.0b013e3181d14633. Epub 2010 Mar 11.
- Background: PubMed 20831630Sofi F, Valecchi D, Bacci D, Abbate R, Gensini GF, Casini A, Macchi C. Physical activity and risk of cognitive decline: a meta-analysis of prospective studies. J Intern Med. 2011 Jan;269(1):107-17. doi: 10.1111/j.1365-2796.2010.02281.x. Epub 2010 Sep 10.
- Background: PubMed 23471631Huckans M, Hutson L, Twamley E, Jak A, Kaye J, Storzbach D. Efficacy of cognitive rehabilitation therapies for mild cognitive impairment (MCI) in older adults: working toward a theoretical model and evidence-based interventions. Neuropsychol Rev. 2013 Mar;23(1):63-80. doi: 10.1007/s11065-013-9230-9. Epub 2013 Mar 8.
- Background: PubMed 21438861Snowden M, Steinman L, Mochan K, Grodstein F, Prohaska TR, Thurman DJ, Brown DR, Laditka JN, Soares J, Zweiback DJ, Little D, Anderson LA. Effect of exercise on cognitive performance in community-dwelling older adults: review of intervention trials and recommendations for public health practice and research. J Am Geriatr Soc. 2011 Apr;59(4):704-16. doi: 10.1111/j.1532-5415.2011.03323.x. Epub 2011 Mar 25.
- Background: PubMed 29592650Kramer AF, Colcombe S. Fitness Effects on the Cognitive Function of Older Adults: A Meta-Analytic Study-Revisited. Perspect Psychol Sci. 2018 Mar;13(2):213-217. doi: 10.1177/1745691617707316.
- Background: PubMed 24705268Bamidis PD, Vivas AB, Styliadis C, Frantzidis C, Klados M, Schlee W, Siountas A, Papageorgiou SG. A review of physical and cognitive interventions in aging. Neurosci Biobehav Rev. 2014 Jul;44:206-20. doi: 10.1016/j.neubiorev.2014.03.019. Epub 2014 Apr 4.
- Background: PubMed 27423932Zhu X, Yin S, Lang M, He R, Li J. The more the better? A meta-analysis on effects of combined cognitive and physical intervention on cognition in healthy older adults. Ageing Res Rev. 2016 Nov;31:67-79. doi: 10.1016/j.arr.2016.07.003. Epub 2016 Jul 14.
- Background: PubMed 24632497Law LL, Barnett F, Yau MK, Gray MA. Effects of combined cognitive and exercise interventions on cognition in older adults with and without cognitive impairment: a systematic review. Ageing Res Rev. 2014 May;15:61-75. doi: 10.1016/j.arr.2014.02.008. Epub 2014 Mar 12.
- World Health Organization (WHO) definitionsLink provided by the sponsor.
- Rivermead Behavioural Memory Test - Third Edition (RBMT-3)Link provided by the sponsor.
- Use of the Functional Activities Questionnaire in Older Adults with DementiaLink provided by the sponsor.
- Multifactorial Memory QuestionnaireLink provided by the sponsor.
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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.
Jennifer Bramen, PhD principal investigator
Saint John's Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mSIM intervention plus activity monitoring and Activity monitoring in people with Amnestic Mild Cognitive Impairment, run by Jennifer Bramen 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 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 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. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Memory Function Composite Score (time frame: Baseline, approximately 3 months and approximately 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185298, which also lists 48 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 14 Jan 2025.