Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Alzheimer Disease
  • Mild Cognitive Impairment
Type
Interventional
Phase
Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment

Participation Requirements

Age
Between 65 years and 85 years
Gender
Both males and females

Description

Clinical Trial Study Design: Pilot Individually Randomized Group-Treatment Trial Study Site: University of Delaware 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 wav...

Clinical Trial Study Design: Pilot Individually Randomized Group-Treatment Trial Study Site: University of Delaware 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. Each wave will consist of 10 completers with MCI; for a total of 5 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 (n=25) or delayed treatment control (n=25) 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.

Tracking Information

NCT #
NCT04820335
Collaborators
Not Provided
Investigators
Not Provided