65 Participants Needed

Compensatory Cognitive Rehabilitation for Mild Cognitive Impairment

AM
Overseen ByAlyssa M Lanzi, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Delaware
Must be taking: Nootropics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Alzheimer's disease (AD) is one of the leading causes of disability in older adults. Because pharmacological approaches do not seem to prevent or slow the disease, clinicians need non-pharmacological interventions that might help people with AD remain independent for as long as possible. This study aims to evaluate the effects of a new behavioral treatment, the Structured External Memory Aid Treatment (SEMAT), for adults with mild cognitive impairment (MCI) designed to promote independent living skills by explicitly teaching the use of strategies and tools to compensate for cognitive weaknesses. Aim 1: Evaluate the efficacy of the SEMAT for improving functional performance in a pilot randomized trial. Aim 2: Evaluate demographic, clinical, and neuropsychological predictors of treatment adherence. Aim 3: Develop and refine the SEMAT manual and other materials for training future interventionists.

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 data supports the effectiveness of the treatment Structured External Memory Aid Treatment (SEMAT) for Mild Cognitive Impairment?

Research shows that using external memory aids, like calendars and notes, can help people with mild memory issues manage daily tasks better. Studies on similar treatments have found improvements in memory and quality of life for those with mild cognitive impairment.12345

Is Compensatory Cognitive Rehabilitation safe for humans?

The available research does not provide specific safety data for Compensatory Cognitive Rehabilitation or its related treatments like SEMAT, but these interventions generally involve non-invasive techniques such as using memory aids, which are typically considered safe for humans.12678

How is the SEMAT treatment different from other treatments for mild cognitive impairment?

SEMAT is unique because it focuses on using structured external memory aids, like calendars and notes, to help individuals with mild cognitive impairment manage their memory challenges in everyday life. This approach is different from other treatments that may focus on retraining memory skills or using electronic devices.1591011

Eligibility Criteria

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.
See 2 more

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.
See 3 more

Timeline

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)

Treatment Details

Interventions

  • Structured External Memory Aid Treatment (SEMAT)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate Treatment GroupExperimental Treatment1 Intervention
Participants will complete 7, 60-minute SEMAT sessions over 7 weeks with their group.
Group II: Delayed Treatment ControlActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials
167
Recruited
25,700+

Findings from Research

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.
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.
Development and Initial Validation of the Functional External Memory Aid Tool.Lanzi, A., Bourgeois, MS., Dedrick, RF.[2021]
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.
Memory Support System training in mild cognitive impairment: Predictors of learning and adherence.De Wit, L., Chandler, M., Amofa, P., et al.[2022]

References

The Functional External Memory Aid Tool Version 2.0: A How-To Clinical Guide. [2023]
Development and Initial Validation of the Functional External Memory Aid Tool. [2021]
Memory Support System training in mild cognitive impairment: Predictors of learning and adherence. [2022]
Effects of An Occupational Therapy Memory Strategy Education Group Intervention on Irish Older Adults' Self-Management of Everyday Memory Difficulties. [2019]
Cognitive intervention programs for individuals with mild cognitive impairment: systematic review of the literature. [2022]
A critical review of memory stimulation programs in Alzheimer's disease. [2022]
Effects of spaced retrieval training with errorless learning in the rehabilitation of patients with dementia. [2020]
Cognitive Improvement in Older Adults with Mild Cognitive Impairment: Evidence from a Multi-Strategic Metamemory Training. [2020]
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. [2018]
An electronic memory aid to support prospective memory in patients in the early stages of Alzheimer's disease: a pilot study. [2004]
Evidence-based practice recommendations for memory rehabilitation. [2011]