Telehealth-Adapted Compensatory Training and Intervention for Cognition (TACTIC)
Telehealth-Adapted Compensatory Training and Intervention for Cognition for People With Mild Cognitive Impairment
The goal of this clinical trial is to develop a five-week virtual cognitive training intervention for people with Mild Cognitive Impairment (MCI) based off an existing eight-week intervention. The main question it aims to answer is:
• Is five weeks of training as good as eight weeks in improving cognition, quality of life, daily functioning, and mood, and in reducing caregiver burden? Researchers will compare five weeks of cognitive training to eight weeks of training to see if the shorter version is as effective as the full training.
Participants will complete all activities virtually:
- Complete a screening visit with a study partner (typically a family member, roommate, or close friend) to determine eligibility to participate in the study
- Complete some tests of memory and thinking and some questionnaires
- Attend weekly two-hour group cognitive training sessions with a trained group leader, for five or eight weeks
- Redo the questionnaires and tests of memory and thinking immediately after completing the training, and three months after completing the training
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
The purpose of this project is to assess the efficacy of brief and full compensatory cognitive training protocols in people diagnosed with Mild Cognitive Impairment (MCI), a state often thought of as a transitory stage between normal aging and dementia. According to the Alzheimer's Association, one in three older adults dies with Alzheimer's disease or another dementia. In 2024, Alzheimer's disease and other dementias were estimated to cost approximately $360 billion, and these costs are only expected to grow, with estimates rising over $1 trillion by 2050. Research on dementia interventions is growing, with research on neurotransmitter augmentation showing cognitive improvement, and more recently, brain stimulation showing gains in memory and general cognition. However, brain stimulation is not yet approved by the U.S. Food and Drug Administration, and eligibility for anti-amyloid medications is restricted to patients with Alzheimer's Disease pathology and low risk profiles, severely limiting accessibility for many patients. Cognitive rehabilitation is a low-cost solution that is not restricted to patients meeting certain requirements or with a specific etiology and can be utilized by any trained clinician.
Cognitive training and rehabilitation is typically categorized as either restorative or compensatory. Restorative training involves repetitive tasks targeting specific cognitive domains (e.g., attention, memory) by harnessing the brain's plasticity and is often completed via computer-based exercises, but often lacks generalizability. Compensatory rehabilitation focuses on individualized strategies that use alternative cognitive processes and supportive aids to compensate for impairment rather than improving it. Cognitive training generally improves quality of life more than pharmacological treatments, and cognitive rehabilitation is particularly effective at improving functional ability and reducing caregiver burden.
Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) is a compensatory cognitive training program which uses cognitive strategies to improve cognition and daily functioning. Originally developed for veterans with traumatic brain injury, it includes a publicly available manual for people with MCI called Motivationally Enhanced Compensatory Cognitive Training for MCI (ME-CCT-MCI), which has shown effectiveness in improving functional ability. This program consists of eight two-hour sessions delivered once per week over eight weeks. However, approximately 74% of providers report modifying CogSMART by combining, modifying, or omitting exercises. Despite this, no research to date has examined the effectiveness of an abbreviated version, though evidence from shorter-term psychotherapy suggests it is not significantly less effective than longer-term approaches. This study will develop and implement a five-session version of ME-CCT-MCI, to reduce time burdens and increase accessibility, feasibility, and adherence for patients, caregivers, and providers.
This proposal advances current science in several ways. First, it further validates the ME-CCT-MCI manual. Though extensive research supported the development of this manual, there has been only one randomized controlled trial validating its use, and only a small number of studies that have since validated its use outside of a Veterans Affairs setting. Of these studies, only two include an assessment of effects on cognition, one of which cites the Indian Adapted ME-CCT-MCI, and the other uses a similar manual adapted for addictions, with no study validating the original manual's effect on cognition. Second, creating and testing a brief version of this manual allows for improved accessibility and feasibility, reducing the risk of dropout. Third, the use of an extensive neuropsychological battery (the National Alzheimer's Coordinating Center Uniform Data Set [NACC-UDS]) allows assessment of improvement in specific cognitive domains. Though the randomized controlled trial did assess effects on objective cognition, it found only a nonsignificant trend and assessed general cognition rather than specific domains. Other research has shown that compensatory cognitive rehabilitation is beneficial to cognition, but there is less clear evidence of the specific pattern of effect on cognitive domains, which may help inform clinical decision making in determining which patients may benefit the most from this intervention. Fourth, this study will investigate what participant factors (i.e., education, baseline cognition, lifestyle, and hippocampal volume) predict benefit of intervention, further determining which patients may benefit from this intervention and contributing to future development of personalized medicine.
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Cameron K Perrin, M.S.
- Phone Number: 352-294-8765
- Email: c.perrin@phhp.ufl.edu
Study Locations
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Florida
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Gainesville, Florida, United States, 32608
- Recruiting
- University of Florida
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 65 years of age or older, less than 85 years
- Have the ability to speak and understand English
- Time and willingness to commit to the completion of this study
- Availability of a study partner (typically a relative, spouse, offspring, or roommate) for initial and post-intervention testing
- A global Clinical Dementia Rating scale (CDR) score of 0.5 and cognitive performance of <26 on the Montreal Cognitive Assessment (MoCA) or <19 on the MoCA-BLIND for categorization of MCI, as determined in the screening appointment.
Exclusion Criteria:
- Self-reported diagnosis of dementia or functional impairment that requires assistance
- Recent changes in medications for memory (i.e., prescribed or changed medications for memory within 30 days)
- Major psychiatric illness (schizophrenia, current substance dependence, or undertreated depression or anxiety), or 15-item Geriatric Depression Scale (GDS-15) score of eight or higher
- Hearing, vision, or motor deficits that would interfere with standardized cognitive assessment or participation in study interventions: e.g., inability to hear through headphones (with or without hearing aids). If vision is corrected with lenses to appropriate levels, then participant will be eligible
- No access to reliable, stable internet, OR
- Current participation in another cognitive training program or treatment study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Brief cognitive training (5 weeks)
Participants in this group will attend the brief, five-week version of cognitive training
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bME-CCT-MCI is a shortened version of the full ME-CCT-MCI, from eight weeks to five weeks.
It preserves core principles of cognitive compensation and habit learning, with a booster summary session in week 5 to reinforce retention.
Other than the condensed material, sessions are the same as those in the full ME-CCT-MCI.
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Active Comparator: Full cognitive training (8 weeks)
Participants in this group will attend the full, eight-week version of cognitive training
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ME-CCT-MCI is a publicly available manual for people with mild cognitive impairment (MCI) which has shown effectiveness in improving cognitive performance.
Course material will be from the manualized protocol by Huckans and Twamley et al. (2018).
The manual includes brief motivational interviewing techniques and modules designed to support behaviors that enhance cognition, such as physical activity, strategies to support learning and memory, mindfulness, and the use of day planners and calendars.
It includes the use of frequent breaks, and at-home practice exercises.
Each weekly session will be completed in groups of 8-10 participants, and will be led by trained intervention leaders.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in quality of life
Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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As assessed by the Quality of Life in Alzheimer's Disease (QOL-AD), completed by participant and study partner, where higher scores indicate better quality of life (range 13-52).
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Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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Change in subjective cognition
Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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As assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 Cognitive Function 8a, a self-report cognitive functioning questionnaire, where a higher score indicates better reported cognition (range 8-40).
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Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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Change in anxiety
Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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As assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale, a self-report questionnaire of anxiety, where higher scores indicate higher levels of anxiety (range 0 to 21).
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Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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Change in depression
Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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As assessed by the Geriatric Depression Scale (GDS), a self-report questionnaire of depression, where higher scores indicate higher levels of depression (range 0 to 15).
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Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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Change in caregiver burden
Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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As assessed by the Zarit Burden Interview (ZBI), completed by study partner, where a higher score indicates higher burden (range 0 to 48).
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Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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Change in cognition
Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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As assessed by the National Alzheimer's Coordinating Center Uniform Data Set version 4 (NACC-UDSv4).
This full neuropsychological assessment consists of neuropsychological tests including: Montreal Cognitive Assessment (MoCA)-BLIND, Craft Story 21, Benson Complex Figure, Number Span Test (Forward and Backward), Category Fluency, Trail Making Test, Verbal Fluency: Phonemic Test, Rey Auditory Verbal Learning Test (RAVLT), and Multilingual Naming Test (MINT).
On most of these tasks a higher score indicates better cognition, except for on Trail Making Test, where a lower score indicates faster time (better cognition).
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Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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Change in reported daily functioning
Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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As assessed by the National Alzheimer's Coordinating Center (NACC) Functional Assessment Scale (FAS), completed by the study partner, where a lower score indicates more independence (range 0 to 30).
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Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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Change in objective functional status
Time Frame: Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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As assessed by the internet-based Bill-Paying Task, an objective measure of functional status which can be administered online, as a test of participants' ability to pay fictional bills.
A higher score indicates more severe deficits (range 0-25).
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Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Individual characteristics that predict cognitive benefits of intervention
Time Frame: Baseline
|
Assess moderation effects of education, baseline cognitive scores, baseline physical activity levels and sleep, and neuroimaging (Magnetic Resonance Imaging [MRI]) on predicting a greater benefit of intervention on cognition.
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Baseline
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment satisfaction
Time Frame: End of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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As assessed by the Client Satisfaction Questionnaire (CSQ-8), completed by participant and study partner, where a higher score indicates greater satisfaction (range 8 to 32).
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End of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)
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Familiarity with Telehealth
Time Frame: Baseline
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Assess/control for how familiarity with virtual/telehealth formats may impact the effectiveness of treatment, as assessed via the Patient Telehealth Readiness Assessment tool created by the National Center for Farmworker Health.
Scores range from 0 to 18, where 0 indicates minimal familiarity with telehealth platforms and 18 indicates good familiarity.
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Baseline
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Cameron K Perrin, M.S., University of Florida
- Principal Investigator: Joseph M Gullett, Ph.D., University of Florida
Publications and helpful links
General Publications
- Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Huckans 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.
- Twamley EW, Jak AJ, Delis DC, Bondi MW, Lohr JB. Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for veterans with traumatic brain injury: pilot randomized controlled trial. J Rehabil Res Dev. 2014;51(1):59-70. doi: 10.1682/JRRD.2013.01.0020.
- Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Lindamer L, Almklov E, Pittman JOE, Shi S, Maye J, Jak A, Twamley E, Rabin B. Multi-method study of the implementation of Cognitive Symptom Management and Rehabilitation Training (CogSMART) in real-world settings. BMC Health Serv Res. 2022 Dec 17;22(1):1542. doi: 10.1186/s12913-022-08941-z.
- Juul S, Jakobsen JC, Jorgensen CK, Poulsen S, Sorensen P, Simonsen S. The difference between shorter- versus longer-term psychotherapy for adult mental health disorders: a systematic review with meta-analysis. BMC Psychiatry. 2023 Jun 16;23(1):438. doi: 10.1186/s12888-023-04895-6.
- Stypulkowski K, Anquillare E, Twamley EW, Thayer RE. Feasibility of a Telehealth Compensatory Cognitive Training Program for Older Adults with Mild Cognitive Impairment. Clin Gerontol. 2024 Jan-Dec;47(1):17-25. doi: 10.1080/07317115.2023.2213694. Epub 2023 May 17.
- Beekly DL, Ramos EM, Lee WW, Deitrich WD, Jacka ME, Wu J, Hubbard JL, Koepsell TD, Morris JC, Kukull WA; NIA Alzheimer's Disease Centers. The National Alzheimer's Coordinating Center (NACC) database: the Uniform Data Set. Alzheimer Dis Assoc Disord. 2007 Jul-Sep;21(3):249-58. doi: 10.1097/WAD.0b013e318142774e.
- Huang HC, Tseng YM, Chen YC, Chen PY, Chiu HY. Diagnostic accuracy of the Clinical Dementia Rating Scale for detecting mild cognitive impairment and dementia: A bivariate meta-analysis. Int J Geriatr Psychiatry. 2021 Feb;36(2):239-251. doi: 10.1002/gps.5436. Epub 2020 Oct 9.
- Lai JS, Wagner LI, Jacobsen PB, Cella D. Self-reported cognitive concerns and abilities: two sides of one coin? Psychooncology. 2014 Oct;23(10):1133-41. doi: 10.1002/pon.3522. Epub 2014 Apr 3.
- Gullett JM, Albizu A, Fang R, Loewenstein DA, Duara R, Rosselli M, Armstrong MJ, Rundek T, Hausman HK, Dekosky ST, Woods AJ, Cohen RA. Baseline Neuroimaging Predicts Decline to Dementia From Amnestic Mild Cognitive Impairment. Front Aging Neurosci. 2021 Dec 7;13:758298. doi: 10.3389/fnagi.2021.758298. eCollection 2021.
- Paggetti A, Druda Y, Sciancalepore F, Della Gatta F, Ancidoni A, Locuratolo N, Piscopo P, Vignatelli L, Sagliocca L, Guaita A, Secreto P, Stracciari A, Caffarra P, Vanacore N, Fabrizi E, Lacorte E; Italian Dementia Guideline Working Group. The efficacy of cognitive stimulation, cognitive training, and cognitive rehabilitation for people living with dementia: a systematic review and meta-analysis. Geroscience. 2025 Feb;47(1):409-444. doi: 10.1007/s11357-024-01400-z. Epub 2024 Nov 1.
- Luxton D, Thorpe N, Crane E, Warne M, Cornwall O, El-Dalil D, Matthews J, Rajkumar AP. Systematic review of the efficacy of pharmacological and non-pharmacological interventions for improving quality of life of people with dementia. Br J Psychiatry. 2026 Jan;228(1):55-67. doi: 10.1192/bjp.2025.11. Epub 2025 Apr 1.
- Gopi Y, Wilding E, Madan CR. Memory rehabilitation: restorative, specific knowledge acquisition, compensatory, and holistic approaches. Cogn Process. 2022 Nov;23(4):537-557. doi: 10.1007/s10339-022-01099-w. Epub 2022 Jul 5.
- Jak A. Cognitive Rehabilitation for Adults with a History of Traumatic Brain Injury. Neurol Clin. 2024 Nov;42(4):931-941. doi: 10.1016/j.ncl.2024.05.015. Epub 2024 Jun 15.
- Fox NC, Belder C, Ballard C, Kales HC, Mummery C, Caramelli P, Ciccarelli O, Frederiksen KS, Gomez-Isla T, Ismail Z, Paquet C, Petersen RC, Perneczky R, Robinson L, Sayin O, Frisoni GB. Treatment for Alzheimer's disease. Lancet. 2025 Sep 27;406(10510):1408-1423. doi: 10.1016/S0140-6736(25)01329-7. Epub 2025 Sep 22.
- Majdi A, van Boekholdt L, Sadigh-Eteghad S, Mc Laughlin M. A systematic review and meta-analysis of transcranial direct-current stimulation effects on cognitive function in patients with Alzheimer's disease. Mol Psychiatry. 2022 Apr;27(4):2000-2009. doi: 10.1038/s41380-022-01444-7. Epub 2022 Feb 3.
- Heidebrink JL, Paulson HL. Lessons Learned from Approval of Aducanumab for Alzheimer's Disease. Annu Rev Med. 2024 Jan 29;75:99-111. doi: 10.1146/annurev-med-051022-043645.
- Olivares D, Deshpande VK, Shi Y, Lahiri DK, Greig NH, Rogers JT, Huang X. N-methyl D-aspartate (NMDA) receptor antagonists and memantine treatment for Alzheimer's disease, vascular dementia and Parkinson's disease. Curr Alzheimer Res. 2012 Jul;9(6):746-58. doi: 10.2174/156720512801322564.
- Danysz W, Parsons CG. The NMDA receptor antagonist memantine as a symptomatological and neuroprotective treatment for Alzheimer's disease: preclinical evidence. Int J Geriatr Psychiatry. 2003 Sep;18(Suppl 1):S23-32. doi: 10.1002/gps.938.
- Anand P, Singh B. A review on cholinesterase inhibitors for Alzheimer's disease. Arch Pharm Res. 2013 Apr;36(4):375-99. doi: 10.1007/s12272-013-0036-3. Epub 2013 Feb 24.
- Birks J. Cholinesterase inhibitors for Alzheimer's disease. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD005593. doi: 10.1002/14651858.CD005593.
- Campbell, L., Maye, J., Thomas, K., Pickell, D., Keller, A., Mahmood, Z., Sano, E., Austin, T., Zakrzewski, J., Silverman, I., Thomas, M., Jak, A., O'Neill, M., & Twamley, E. (2026, February 6). Motivationally Enhanced Compensatory Cognitive Training for Older Veterans with Mild Cognitive Impairment: A Randomized Controlled Trial. INS Philadelphia 2026: The 54th Annual Meeting.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IRB202501616
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The cognitive assessment data will be deidentified and made publicly available upon study completion. Permission to disseminate the neuroimaging data to a larger audience has not been granted so this will not be included in the publicly available dataset.
A data dictionary will be available accompanying the cognitive assessment data. The manual for the compensatory training intervention (Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment) is already publicly available, and any changes made in this study to create a brief version will also be shared.
Code created to analyze the results data (in R, python, or MATLAB) will be cleaned for comprehension and shared to support replication.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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