What side effects are associated with this type of intervention?

Non-pharmacological treatments for Alzheimer's Disease, such as the Structured External Memory Aid Treatment (SEMAT), focus on behavioral interventions designed to teach strategies and tools to compensate for cognitive weaknesses. These interventions generally have minimal physical side effects compared to pharmacological treatments. However, they may lead to psychological or emotional responses such as frustration, anxiety, or stress, particularly if the patient finds the strategies challenging to implement. Additionally, the effectiveness of these interventions can vary, and some patients may not experience significant improvements, which could potentially lead to feelings of disappointment or decreased motivation.

What prior FDA approvals exist?

FDA-approved treatments for Alzheimer's Disease primarily include pharmacological options such as cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and the NMDA receptor antagonist memantine. These drugs aim to manage symptoms but do not cure the disease. While the SEMAT trial focuses on a behavioral intervention to teach compensatory strategies for cognitive weaknesses, there are no FDA-approved behavioral treatments specifically for Alzheimer's Disease. However, non-pharmacological approaches like cognitive rehabilitation and memory training are often recommended as complementary therapies to support cognitive function and independence.

What other types of research exist?

Promising novel alternatives to SEMAT for Alzheimer's Disease patients include: 1) Multicomponent behavioral sleep interventions, which involve sleep hygiene education, consistent sleep-wake schedules, light therapy, and exercise to improve sleep and circadian rhythms. 2) Cognitive Behavioral Therapy for Insomnia (CBT-I), which addresses insomnia symptoms and can help reduce anxiety and improve sleep quality. 3) Environmental restructuring, which includes modifying the living environment to support cognitive function and reduce confusion. 4) Physical exercise programs, which have been shown to improve cognitive function and overall well-being in AD patients. These interventions focus on holistic approaches to manage symptoms and improve the quality of life for AD patients.

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Compensatory Cognitive Rehabilitation for Mild Cognitive Impairment

N/A

Recruiting

Research Sponsored by University of Delaware

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

60-90 years of age

Amnestic mild cognitive impairment from probable Alzheimer's disease

Must not have

Untreated major depression

Major auditory, visual, or motor impairment that would affect their ability to participate in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to immediately post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will help determine if the new behavioral treatment, SEMAT, can help improve functional performance in adults with mild cognitive impairment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since SEMAT is a non-pharmacological intervention involving behavioral therapy focused on compensatory techniques for memory aid rather than medication, it does not have traditional side effects associated with drugs but may include potential stress or frustration during adaptation to new strategies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 60 and 90 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have major depression that has not been treated.

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

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I have a medical condition that affects my thinking or memory.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to immediately post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to immediately post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to immediately post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Memory Based Compensation

Changes in Memory Based Everyday Function

Secondary study objectives

Changes in Cognitive Abilities

Changes in Everyday Strategy Use

Changes in Executive Functioning Skills

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Alzheimer's Disease include cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors work by preventing the breakdown of acetylcholine, a neurotransmitter important for learning and memory, thereby enhancing cholinergic function. Memantine regulates glutamate activity to prevent excitotoxicity, which can damage neurons. Behavioral interventions like the Structured External Memory Aid Treatment (SEMAT) focus on teaching patients strategies and tools to compensate for cognitive weaknesses, promoting independence and improving quality of life. These interventions are crucial as they address the functional impairments caused by AD, helping patients maintain daily living skills and reducing caregiver burden.