Compensatory Cognitive Rehabilitation for Mild Cognitive Impairment

Overseen By Alyssa M Lanzi, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Must be taking: Nootropics

Disqualifiers: Schizophrenia, Untreated depression, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new behavioral treatment called the Structured External Memory Aid Treatment (SEMAT) for individuals with mild cognitive impairment (MCI) due to probable Alzheimer's disease. The goal is to help participants improve daily living skills by teaching strategies and tools to manage memory challenges. Participants will be divided into two groups: one will start the treatment immediately, while the other will begin after eight weeks. Those experiencing memory issues related to Alzheimer's and not currently in another memory-related study might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance memory support strategies for Alzheimer's patients.

Will I have to stop taking my current medications?

The trial requires that participants are either not taking nootropic medications or have been stable on them for more than 2 months. If you are currently taking nootropic meds, you must have been on a stable dose for at least 2 months to participate.

What prior data suggests that the Structured External Memory Aid Treatment (SEMAT) is safe for adults with mild cognitive impairment?

Research has shown that the Structured External Memory Aid Treatment (SEMAT) is generally easy for participants to handle. Studies found that people who tried this treatment found it acceptable and continued with it over time. No reports of serious side effects have been linked to SEMAT. As a non-drug treatment, it focuses on teaching memory strategies and using tools to help with memory problems. This approach is less likely to cause side effects compared to medications. Participants in past studies completed their sessions without major issues, suggesting that SEMAT is safe for people with mild memory problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effectiveness of Structured External Memory Aid Treatment (SEMAT) for individuals with mild cognitive impairment, a condition often addressed with medications like donepezil or lifestyle interventions such as cognitive training. Unlike standard treatments that focus primarily on slowing cognitive decline, SEMAT is a non-pharmacological approach that emphasizes practical strategies to enhance memory using external aids. This method offers a unique angle by empowering patients with tangible tools to manage their cognitive challenges directly, potentially leading to improved daily functioning and quality of life. Additionally, the trial's design, which includes both immediate and delayed treatment groups, will help researchers understand the optimal timing and impact of this intervention.

What evidence suggests that the Structured External Memory Aid Treatment (SEMAT) might be an effective treatment for mild cognitive impairment?

Research has shown that the Structured External Memory Aid Treatment (SEMAT) can help individuals with mild cognitive impairment (MCI) enhance their daily living skills. In this trial, participants in the Immediate Treatment Group will complete seven 60-minute SEMAT sessions over seven weeks. Studies have found that memory aids like SEMAT effectively assist those with MCI in remembering and managing everyday tasks. Specifically, one study found that these aids improved performance in activities such as taking medication and other daily routines. These aids teach people how to use tools and strategies to remember important information, helping them maintain independence. Early findings suggest that participants find SEMAT easy to use and continue with it over time, indicating potential long-term benefits. Meanwhile, participants in the Delayed Treatment Control group will receive SEMAT after an eight-week period. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 60-90 with mild cognitive impairment from probable Alzheimer's, who have functional vision and hearing. They must be stable on or not taking memory medications. Excluded are those with other diseases causing cognitive issues, major sensory or motor impairments, psychiatric disorders like schizophrenia, untreated depression, substance use disorder in the past 5 years, or involvement in another memory-related trial.

Inclusion Criteria

Functional Vision and Hearing to Complete Phone Screen

I am between 60 and 90 years old.

I have memory loss issues likely due to Alzheimer's.

Exclusion Criteria

I have major depression that has not been treated.

I do not have major hearing, vision, or movement issues affecting study participation.

You have had a problem with drugs or alcohol in the past 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants complete baseline testing before starting treatment

1 week

1 visit (virtual)

Immediate Treatment

Participants in the immediate treatment group complete 7 weeks of SEMAT sessions

7 weeks

7 visits (virtual)

Delayed Treatment

Participants in the delayed treatment group complete 7 weeks of SEMAT sessions after an 8-week delay

7 weeks

7 visits (virtual)

Follow-up

Participants are monitored for maintained changes in memory-based compensation and everyday function

8 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Structured External Memory Aid Treatment (SEMAT)

Trial Overview The study tests a new behavioral treatment called SEMAT designed to help adults with mild cognitive impairment live independently by teaching them strategies and tools to compensate for their cognitive weaknesses. The effectiveness of SEMAT will be evaluated through a pilot randomized trial alongside an assessment of factors influencing treatment adherence.

How Is the Trial Designed?

Group I: Immediate Treatment Group Experimental Treatment 1 Intervention

Participants will complete 7, 60-minute SEMAT sessions over 7 weeks with their group.

Group II: Delayed Treatment Control Active Control 1 Intervention

Participants will not receive the intervention immediately. After 8 weeks, participants in this arm will complete the SEMAT. This is not a crossover design, because the treatment effects from those in the immediate treatment group can not be taken away.

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

Published Research Related to This Trial

In a study of 215 older adults with amnestic mild cognitive impairment (aMCI), better global cognition was found to predict how well individuals learned to use the Memory Support System (MSS) during a two-week training period.

Successful learning of the MSS was linked to higher adherence rates to the system at 6, 12, and 18 months after training, suggesting that early intervention with compensatory strategies could enhance long-term adherence for individuals with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory Support System training in mild cognitive impairment: Predictors of learning and adherence. De Wit, L., Chandler, M., Amofa, P., et al.[2022]

The occupational therapy memory strategy education group (MSEG) significantly improved memory performance and quality of life in participants with varying levels of memory impairment, as evidenced by notable improvements on the Rivermead Behavioural Memory Test and a dementia quality of life measure after a six-week program.

Participants also reported increased use of external memory aids and higher satisfaction with their performance, with these positive effects maintained at a 3-month follow-up, highlighting the effectiveness of occupational therapy in supporting memory management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of An Occupational Therapy Memory Strategy Education Group Intervention on Irish Older Adults' Self-Management of Everyday Memory Difficulties. Coe, Á., Martin, M., Stapleton, T.[2019]

Spaced retrieval training (SRT) combined with errorless learning (EL) significantly improved neuropsychological performance in patients with vascular dementia, as shown by increased scores on the CERAD-K assessment after 5 weeks of intervention.

While SRT with EL was effective for memory training in vascular dementia patients, it did not show significant differences in independent daily living activities or improvements in Alzheimer's disease patients, indicating a need for further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of spaced retrieval training with errorless learning in the rehabilitation of patients with dementia. Jang, JS., Lee, JS., Yoo, DH.[2020]

A novel cognitive training program called multi-strategic metamemory training significantly improved long-term delayed free recall and fluency in 66 older adults with mild cognitive impairment compared to a control group of 47 participants.

Participants in the training group also reported a significant decrease in subjective memory complaints, indicating that the program not only enhanced cognitive performance but also improved their perception of everyday memory function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Improvement in Older Adults with Mild Cognitive Impairment: Evidence from a Multi-Strategic Metamemory Training. Youn, JH., Park, S., Lee, JY., et al.[2020]

The Functional External Memory Aid Tool (FEMAT) is a new, reliable assessment tool designed to help clinicians evaluate how adults with cognitive-communication disorders use external aids in their daily lives, which is crucial for creating personalized treatment plans.

FEMAT is easy to administer, free, and provides valuable data that complements traditional assessment methods, making it a practical resource for clinicians working with this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Functional External Memory Aid Tool Version 2.0: A How-To Clinical Guide. Lanzi, AM., Saylor, AK., Dedrick, RF., et al.[2023]

The Functional External Memory Aid Tool (FEMAT) was developed to reliably measure everyday strategy use in individuals with mild memory impairments, demonstrating a three-factor structure: Medical Tasks, Instrumental Daily Tasks, and Retrieval-Based Tasks.

With a study involving 99 participants, the FEMAT showed strong internal consistency and reliability, making it a valuable tool for clinicians to create personalized interventions for those with cognitive communication challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Initial Validation of the Functional External Memory Aid Tool. Lanzi, A., Bourgeois, MS., Dedrick, RF.[2021]

The USMART program, a tablet-based spaced retrieval training, showed a significant improvement in memory recall among 41 participants with mild cognitive impairment (MCI) over a 4-week period, with an effect size of 0.49.

No adverse events were reported during the study, indicating that USMART is a safe and well-accepted intervention for enhancing memory retrieval in older adults with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program among patients with mild cognitive impairment: a randomized controlled crossover trial. Han, JW., Son, KL., Byun, HJ., et al.[2018]

Memory re-training programs and compensatory approaches are likely effective in improving memory disorders in patients with focal brain lesions, with some benefits extending beyond the specific skills trained.

Assistive devices and targeted learning strategies have shown effectiveness in helping patients with degenerative diseases retain important information for daily life, although variability in study methods may affect the reliability of these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based practice recommendations for memory rehabilitation. Piras, F., Borella, E., Incoccia, C., et al.[2011]

Cognitive intervention programs for individuals with mild cognitive impairment of the amnestic type (MCI-A) showed statistically significant improvements in memory, with 44% of objective memory measures and 49% of subjective measures (like quality of life and mood) demonstrating positive outcomes after training.

The review highlighted the need for larger sample sizes and more robust experimental designs in future studies to enhance the efficacy and standardization of cognitive interventions for MCI-A.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive intervention programs for individuals with mild cognitive impairment: systematic review of the literature. Jean, L., Bergeron, ME., Thivierge, S., et al.[2022]

In a study involving five outpatients aged 58-79 with mild-to-moderate probable Alzheimer's disease, the use of an electronic memory aid (EMA) significantly improved their ability to remember to perform tasks compared to free recall or using a written list.

The findings suggest that EMAs could be a valuable tool for enhancing prospective memory in Alzheimer's patients, and future research should involve larger samples and real-life home settings to further explore this potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An electronic memory aid to support prospective memory in patients in the early stages of Alzheimer's disease: a pilot study. Oriani, M., Moniz-Cook, E., Binetti, G., et al.[2004]

Memory stimulation programs, including errorless learning, spaced retrieval, and dyadic approaches, show promise in improving memory function in Alzheimer's disease patients based on preliminary evidence.

These techniques can be used alone or in combination, suggesting a flexible approach to enhance memory stimulation in individuals with Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critical review of memory stimulation programs in Alzheimer's disease. Grandmaison, E., Simard, M.[2022]

Citations

1. tandfonline.com tandfonline.com/doi/abs/10.1080/02687038.2020.1868395

Structured external memory aid treatment (SEMAT) for ... A review of the effectiveness of memory interventions in mild cognitive impairment (MCI). Source: International Psychogeriatrics. Mild Cognitive Impairment.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31424973/

Structured External Memory Aid Treatment for Mild ... The aims of this study were (a) to examine the effects of a structured external memory aid (EMA) treatment for individuals with possible mild neurocognitive ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04820335

Promoting Independence With Compensatory Cognitive ... This study aims to evaluate the effects of a new behavioral treatment, the Structured External Memory Aid Treatment (SEMAT), for adults with mild cognitive ...

4. pubs.asha.org pubs.asha.org/doi/10.1044/2024_AJSLP-24-00110

Maximizing the “Functional” in the Functional External ... The Functional External Memory Aid Tool (FEMAT) is an 11-item performance-based measure that simulates everyday tasks (eg, medication management) to measure ...

5. researchgate.net researchgate.net/publication/348190199_Structured_external_memory_aid_treatment_SEMAT_for_older_adults_with_mild_cognitive_impairment_long-term_adherence_and_acceptability_of_treatment

Structured external memory aid treatment (SEMAT) for ... Structured external memory aid treatment (SEMAT) for older adults with mild cognitive impairment: long-term adherence and acceptability of treatment · Abstract.