Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment

• Registration Number: NCT05396248
• Lead Sponsor: Kessler Foundation

Brief Summary

The current study is a double-blind, placebo-control randomized clinical trial examining the efficacy of memory retraining in individuals with Mild Cognitive Impairment (MCI). Impairment in higher level cognitive processing, such as new learning and memory, is one of the most common deficits in individuals with MCI and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to treat these cognitive deficits in order to improve the everyday functioning of individuals with MCI. Through a small randomized clinical trial, the investigators found that individuals with MCI with documented cognitive impairment show a significant improvement in their memory performance following a treatment protocol designed to facilitate learning. The current proposal will replicate this finding and further evaluate (a) the impact of the treatment on everyday functioning, (b) the long term efficacy of the treatment and (c) the utility of booster sessions in facilitating long-term treatment effects. We will randomly assign older individuals who meet criteria for a diagnosis of amnestic MCI to a memory retraining group or a placebo control group. Both groups will undergo baseline, immediate and long-term follow-up assessment consisting of: (1) a traditional neuropsychological battery, (2) an assessment of global functioning examining the impact of the treatment on daily activities, and (3) functional neuroimaging. This design will allow the investigators to evaluate the efficacy of this particular memory retraining technique in an aMCI population through the assessment of cognitive function via a standard evaluation. In addition, the investigators will be able to draw conclusions regarding the impact of this particular memory remediation program on everyday life from questionnaires completed by the participant and a significant other. Optional enrollment in pre- post neuroimaging will also allow the investigators to look at changes in the brain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-05-31
• Study Start: 2023-06-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 60 or older.
• read and speak English fluently.
• Research based diagnosis of Amnestic Mild Cognitive Impairment

Exclusion Criteria

• prior stroke or neurological injury/disease (i.e. traumatic brain injury, Multiple Sclerosis, or Stroke).
• history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis).
• significant alcohol or drug abuse history (inpatient treatment).
• Benzodiazepines and steroid use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Verbal list learning	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed	Change in total score from Open-Trial Selective Reminding Test (OT-SRT)
Participation in everyday life	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed	Change in total score from Participation Assessment with Recombined Tools

Secondary Outcome Measures

Name	Time	Method
Self-reported anxiety	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed	Change in total score on the Geriatric Anxiety Scale
Self-reported quality of life	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed	Change in total score on the Quality of Life in Alzheimer's Disease
Self-reported quality of well-being	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed	Change in total score on the Quality of Well-Being Scale - Self-Administered
Functional memory	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed	Change in total score from the modified Everyday Memory Scenarios (EMS)
Story memory	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed	Change in total score from Prose Memory Test
Self-reported depression	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed	Change in total score on the Geriatric Depression Scale
Functional neuroimaging	two points in time: pre-treatment and immediately following treatment	Change in total scores from memory task during fMRI scan

Trial Locations

Locations (2)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Kessler Foundation Research Center; 🇺🇸 West Orange, New Jersey, United States