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Compensatory Cognitive Rehabilitation for Mild Cognitive Impairment

Phase 1
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to immediately post-treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post-treatment to 8-weeks later
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post-treatment to 8-weeks later for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Memory Based Compensation
Changes in Memory Based Everyday Function
Secondary outcome measures
Changes in Cognitive Abilities
Changes in Everyday Strategy Use
Changes in Executive Functioning Skills
+5 more

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.

Find a Location

Who is running the clinical trial?

University of DelawareLead Sponsor
154 Previous Clinical Trials
25,146 Total Patients Enrolled

Media Library

Structured External Memory Aid Treatment (SEMAT) Clinical Trial Eligibility Overview. Trial Name: NCT04820335 — Phase 1
Alzheimer's Disease Research Study Groups: Immediate Treatment Group, Delayed Treatment Control
Alzheimer's Disease Clinical Trial 2023: Structured External Memory Aid Treatment (SEMAT) Highlights & Side Effects. Trial Name: NCT04820335 — Phase 1
Structured External Memory Aid Treatment (SEMAT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04820335 — Phase 1

Frequently Asked Questions

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

What effects is this trial aiming to achieve?

"This clinical trial aims to measure shifts in Memory Based Compensation over a pre- and post-treatment timeframe. Secondary objectives include evaluating changes in Self Efficacy, Quality of Life, and Maintained Changes in Memory Based Everyday Function through the use of the Memory Loss Self Efficacy Scale (9 items rated on 10 point scales from 1 - not at all confident to 10 - fully confident), QOL-AD questionnaire (13 items assessed with 4 point rating scale) as well as ECog Questionnaire (39 items measured with a four-point score system ranging from 1: better or no change; 4: consistently much worse)."

Answered by AI

Does this clinical trial accept participants who are over 45 years of age?

"This trial is open to seniors ages 60-90."

Answered by AI

To whom is eligibility for this research available?

"This research project requires 65 subjects diagnosed with Alzheimer's disease between the ages of 60-90. The following are necessary prerequisites for consideration: elderly age range, command of English language, functional eyesight and hearing to complete phone screen, no recent use or stabilization (2+ months) on cognitive enhancing medications, and amnestic mild cognitive impairment from probable Alzheimer's disorder."

Answered by AI

What potential harms accompany the utilization of Structured External Memory Aid Treatment (SEMAT)?

"Our team has assigned a score of 1 to Structured External Memory Aid Treatment (SEMAT), indicating that there is only limited data available on the safety and efficacy this treatment."

Answered by AI

How extensive is the current participation in this experiment?

"Affirmative. Information on clinicaltrials.gov reveals that this experiment is still in the process of acquiring participants, with 65 participants needed from a single medical facility. This project was initially uploaded to their database on January 5th 2022 and most recently updated 19th May 2022."

Answered by AI

Are there any opportunities for potential participants to enlist in this research project?

"As per the information displayed on clinicaltrials.gov, this particular medical research is currently seeking people to participate in the trial. It was first made public on January 5th 2022 and last revised on May 19th of that same year."

Answered by AI
~6 spots leftby Aug 2024