Structured External Memory Aid Treatment (SEMAT) for Cognitive Decline

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Delaware, Newark, DE
Cognitive Decline+2 More
Structured External Memory Aid Treatment (SEMAT) - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Cognitive Decline

Study Summary

Promoting Independence With Compensatory Cognitive Rehabilitation

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Eligible Conditions

  • Cognitive Decline
  • Cognitive Dysfunction
  • Alzheimer Disease
  • Mild Cognitive Impairment (MCI)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Structured External Memory Aid Treatment (SEMAT) will improve 2 primary outcomes and 9 secondary outcomes in patients with Cognitive Decline. Measurement will happen over the course of Immediately post-treatment to 8-weeks later.

Baseline to immediately post-treatment
Changes in Cognitive Abilities
Changes in Everyday Strategy Use
Changes in Executive Functioning Skills
Changes in Memory Based Compensation
Changes in Memory Based Everyday Function
Changes in Quality of Life
Changes in Self Efficacy
Changes in Self-Reported Cognition
Immediately post-treatment to 8-weeks later
Maintained Changes in Everyday Strategy Use
Maintained Changes in Memory Based Compensation
Maintained Changes in Memory Based Everyday Function

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Immediate Treatment Group

This trial requires 65 total participants across 2 different treatment groups

This trial involves 2 different treatments. Structured External Memory Aid Treatment (SEMAT) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Immediate Treatment Group
Behavioral
Participants will complete 7, 60-minute SEMAT sessions over 7 weeks with their group.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to immediately post-treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to immediately post-treatment for reporting.

Closest Location

University of Delaware - Newark, DE

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
60-90 years of age
English Speaking
Functional Vision and Hearing to Complete Phone Screen
not taking or stable ( >2 months) on nootropic meds
amnestic mild cognitive impairment from probable Alzheimer's disease

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes cognitive decline?

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The process that leads to a decline in cognitive competence can have a variety of causes including age, age-related changes such as hearing loss, and hormonal fluctuations which, while important, do not contribute significantly to cognitive decline.

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What are the signs of cognitive decline?

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The cognitive signs of ageing can be seen in cognitive functioning. Memory and spatial orientation are most at risk. In addition the signs of ageing can lead to difficulty with the executive function of cognition. It is also often the case that dementia can coexist with the signs of ageing, hence the need for early detection and intervention. In addition, these signs may take the form of deterioration (for example, difficulty concentrating, memory problems, trouble thinking, loss of insight, and difficulty speaking).\n

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Can cognitive decline be cured?

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Older adults with mild to moderate cognitive impairment represent a group with substantial, yet manageable, health risks. Treatments that target these problems, such as improving walking abilities, can significantly reduce the risks of falls, hospitalizations, and institutionalization.

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What is cognitive decline?

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Although it is difficult to determine the cause of the development of cognitive decline in late life, it is often accompanied by a decline in some cognitive domains. A large body of research has linked the development of cognitive decline with functional health status. Although cognitive decline may be a part of successful aging, it has also been well documented as an independent predictor of adverse health outcomes in the elderly, including all-cause mortality, cardiovascular disease, and dementia. The effects of cognitive deterioration may not be totally limited to the brain, and therefore the need to better understand the mechanisms underlying the relationship between cognition and functional health should be emphasized by both researchers and clinicians. Furthermore, the detection and management of dementia are very important and should be considered a priority for intervention.

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What are common treatments for cognitive decline?

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The most common treatment for cognitive impairment, regardless of the cause of the impairment, is medication, particularly for mild cognitive impairment. Of these, antidepressants and other medications may also be effective for Alzheimer's disease and other dementias. Cognitive impairment and dementia are increasingly treated with nonpharmacological approaches, including the exercise, enriched environment, and music intervention programs. The role of psychotherapy has yet to be explored.

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How many people get cognitive decline a year in the United States?

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Approximately 32 million Americans have at least one cognitive decline event each year. The prevalence of cognitive decline increases with age. The occurrence of one or more cognitive decline events by year 5 predicted future declines in cognition beyond age- and education-based effects. Older women have a lower risk for cognitive decline than older men.

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Who should consider clinical trials for cognitive decline?

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Results from a recent paper highlighted the need for a comprehensive dementia screening strategy in order to make the most of the opportunities for research, as well as the risk and burden to the individual. Although most people aged 80+ have not reported memory changes, this study demonstrates that trials for dementia might offer an attractive and economically advantageous alternative to community-based support.

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What does structured external memory aid treatment (semat) usually treat?

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Results from a recent clinical trial suggests not only the potential benefits of treatment but also a wider range of cognitive complaints that could be amenable to a specific treatment--the use of an external memory aid--and that the presence or absence of the memory aid can influence the effects of treatment on cognition.

Unverified Answer

What is the latest research for cognitive decline?

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A great deal of research has shown that cognitive decline does not exist and is not related to normal aging. There is therefore no evidence of an association between chronic fatigue and cognitive impairment.

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Have there been other clinical trials involving structured external memory aid treatment (semat)?

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Clinical trials have been conducted involving [semat]-related methods and devices such as [semat-guided training (STG) and visual-spatial attention training (VSTG)(] and [semat-based cognitive training (CB). The objective n of these clinical studies was to determine whether or not external memory aids (i.e. semat) can be used as a treatment method by itself. However, semat is not usually considered semat-friendly by medical professionals but rather semat is only used to evaluate semat-related strategies such as STG/VSTG.

Unverified Answer

What are the latest developments in structured external memory aid treatment (semat) for therapeutic use?

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A high effect size was found and the results point to an important clinical effect. Therefore, the SEM-Program is a promising treatment modality that deserves further consideration.

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What is the primary cause of cognitive decline?

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Results from a recent clinical trial provides only a preliminary estimation of the size of the association between a cognitive complaint and change in PAD-C scores. There are limitations in this study in terms of the generalizability of the findings to the wider stroke population and the limitations of this cross-sectional study design.

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