Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-04 @ 9:58 PM
Study NCT ID:
NCT04820335
Status:
RECRUITING
Last Update Posted:
2024-11-22
First Post:
2021-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Independence With Compensatory Cognitive Rehabilitation
Sponsor:
University of Delaware
Organization:
Study Overview
Official Title:
Promoting Independence With Compensatory Cognitive Rehabilitation: A Pilot Clinical Trial for Early-Stage Alzheimer's Disease
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
Clinical Trial Study Design: Pilot Individually Randomized Group-Treatment Trial
Study Site: University of Delaware. All research activities will occur via telehealth.
Study Participants: Approximately 65 older adults will be recruited to participate to ensure 50 completers with MCI. Participants will be recruited and complete study procedures in waves.
Randomization: Following the screening criteria session and informed consent, if the participant met the criteria for amnestic MCI he/she will be randomly assigned to the immediate treatment or delayed treatment control condition.
Study Procedures Aim 1: Clinical Trial. Once randomly assigned to a condition, participants will complete baseline testing and additional testing at two other time periods: weeks 8 and 16. Participants in the immediate treatment condition will then complete 7-weeks of the group SEMAT. At week 8, participants in both groups will complete assessments. Then, those in the delayed treatment group will complete 7-weeks of treatment. At week 16, participants in both conditions will complete assessments. During assessment sessions, participants will complete performance-based and self-reported measures of independent daily tasks and tests of thinking and memory independently with an assessor for approximately 1 hour. During treatment sessions (approximately 60 minutes), participants will interact with group-mates and learn how use three different categories of external memory aids. Treatment sessions will be video recorded and transcribed.
* Aim 2a: The 50 participants with MCI who are enrolled in Aim 1 activities will also be included in Aim 2. Participants will complete additional self-report measures of efficacy and depression prior to the active phase of treatment either during baseline or week 8 (Aim 1).
* Aim 2b: The investigators will randomly select a subpopulation of participants with single-domain aMCI (n=15) and multi-domain aMCI (n=15), as well as their study partners (n=15; n=15) to complete cognitive interviewing immediately following completion of the active phase of the intervention (Aim 1). Participants will engage in semi-structured interviews that will take approximately 1 hour and will be video recorded, transcribed, and qualitatively analyzed for themes that are discussed.
Study Duration: Each participant will be involved for approximately 18 weeks (including screening criteria session and cognitive interviews, if applicable)
Retention of Subjects: The investigators will stagger participant payments and over recruit.
Control condition: No treatment
Intervention: The Structured External Memory Aid Treatment (SEMAT): A 7-week treatment that will teach three categories of external memory aids to participants to help compensate for everyday memory challenges. This is a behavioral intervention.
Study Site: University of Delaware. All research activities will occur via telehealth.
Study Participants: Approximately 65 older adults will be recruited to participate to ensure 50 completers with MCI. Participants will be recruited and complete study procedures in waves.
Randomization: Following the screening criteria session and informed consent, if the participant met the criteria for amnestic MCI he/she will be randomly assigned to the immediate treatment or delayed treatment control condition.
Study Procedures Aim 1: Clinical Trial. Once randomly assigned to a condition, participants will complete baseline testing and additional testing at two other time periods: weeks 8 and 16. Participants in the immediate treatment condition will then complete 7-weeks of the group SEMAT. At week 8, participants in both groups will complete assessments. Then, those in the delayed treatment group will complete 7-weeks of treatment. At week 16, participants in both conditions will complete assessments. During assessment sessions, participants will complete performance-based and self-reported measures of independent daily tasks and tests of thinking and memory independently with an assessor for approximately 1 hour. During treatment sessions (approximately 60 minutes), participants will interact with group-mates and learn how use three different categories of external memory aids. Treatment sessions will be video recorded and transcribed.
* Aim 2a: The 50 participants with MCI who are enrolled in Aim 1 activities will also be included in Aim 2. Participants will complete additional self-report measures of efficacy and depression prior to the active phase of treatment either during baseline or week 8 (Aim 1).
* Aim 2b: The investigators will randomly select a subpopulation of participants with single-domain aMCI (n=15) and multi-domain aMCI (n=15), as well as their study partners (n=15; n=15) to complete cognitive interviewing immediately following completion of the active phase of the intervention (Aim 1). Participants will engage in semi-structured interviews that will take approximately 1 hour and will be video recorded, transcribed, and qualitatively analyzed for themes that are discussed.
Study Duration: Each participant will be involved for approximately 18 weeks (including screening criteria session and cognitive interviews, if applicable)
Retention of Subjects: The investigators will stagger participant payments and over recruit.
Control condition: No treatment
Intervention: The Structured External Memory Aid Treatment (SEMAT): A 7-week treatment that will teach three categories of external memory aids to participants to help compensate for everyday memory challenges. This is a behavioral intervention.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: