Improve New Learning and Memory in Individuals With Mild Cognitive Impairment
NCT05396248 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-05-16
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.
Conditions
Interventions
- BEHAVIORAL
-
Memory Retraining Exercises
Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
- BEHAVIORAL
-
Placebo Control Memory Exercises
Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
Sponsors & Collaborators
- collaborator OTHER
- collaborator OTHER
-
Kessler Foundation
lead OTHER
Principal Investigators
-
Nancy Chiaravalloti · Kessler Foundation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-28
- Primary Completion
- 2027-03-31
- Completion
- 2027-03-31
Countries
- United States
Study Locations
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