Brief Cognitive Training for Mild Cognitive Impairment
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About
The goal of this clinical trial is to develop a five-week cognitive training intervention for people with Mild Cognitive Impairment (MCI). 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: [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
- Complete a virtual screening visit with a study partner (typically a family member, roommate, or close friend) to determine eligibility to participate in the study
- Complete some in-person tests of memory and thinking on the University of Florida's campus, and some questionnaires
- Attend weekly two-hour group cognitive training sessions with a trained group leader on campus, for five or eight weeks
- Redo the in-person questionnaires and tests of memory and thinking immediately after completing the training, and three months after completing the training
Full description
Background:
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. Although research in pharmacological and brain stimulation interventions is growing, 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. 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 patient 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 cognitive performance. 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 have only been a small number of studies that have since validated its use. Of these studies, two cite the Indian Adapted ME-CCT-MCI, two study telehealth adaptations, and the last focuses on physical activity and sleep, with no evaluation of its effect on cognition. Second, creating and testing a brief version of this manual allows for improved accessibility. 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 research has shown that compensatory cognitive rehabilitation is beneficial to cognition, 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, and hippocampal volume) predict benefit of intervention, further determining which patients may benefit from this intervention and contributing to future development of personalized medicine.
Specific Aims:
Aim 1: Determine the impact of a feasibility-focused five-session version compared to the full version of the ME-CCT-MCI on cognition, quality of life, daily functioning, mood, and caregiver burden. H1.1: The brief version will not have a worse benefit to participants than the full version of ME-CCT-MCI. H1.2: Benefits of intervention in both groups will be seen particularly in quality of life, activities of daily living, and caregiver burden. Within cognitive domains, there will be particular benefit to learning and executive functioning compared to processing speed and language.
Aim 2 (Exploratory): Investigate individual characteristics that predict cognitive benefits of intervention. Assess moderation effects of demographic factors, baseline cognitive scores, and neuroimaging (Magnetic Resonance Imaging [MRI]) on predicting a greater benefit of intervention on cognition. H2.1: Participants with lower education levels and poorer baseline cognition will show less cognitive benefit from the interventions compared to those with higher education and better baseline performance. H2.2: Lower hippocampal volume will similarly be associated with reduced benefit to cognition compared to those with greater hippocampal volume.
Enrollment
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Inclusion criteria
- Greater than 65 years of age
- 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
- Evidence of a previous MCI diagnosis from participation in another Center for Cognitive Aging and Memory (CAM) study, or a global Clinical Dementia Rating scale (CDR) score of 0.5 and cognitive performance of <26 on the Montreal Cognitive Assessment (MoCA)
Exclusion criteria
- Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality) or any history of agitation and/or delirium
- Hearing or vision deficits that would interfere with standardized cognitive assessment or participation in study interventions: i.e. inability to hear through headphones (with or without hearing aids), macular degeneration or other significant diseases that cause severe loss of vision. If vision is corrected with lenses to appropriate levels, then participant will be eligible.
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Cameron K Perrin, M.S.
Data sourced from clinicaltrials.gov
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