Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Study Overview
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Brief Summary
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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.

Official Title
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Use of a Memory Technique to Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Memory Retraining Exercises
* Behavioral: Placebo Control Memory Exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for five weeks (10 training sessions). | Behavioral: Memory Retraining Exercises<br>* Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).<br>|
| Placebo Comparator: Placebo Control Group<br>The placebo control group will receive placebo memory exercises administered on a laptop computer twice a week for five weeks (10 placebo control sessions). | Behavioral: Placebo Control Memory Exercises<br>* Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported depression | Change in total score on the Geriatric Depression Scale | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | 
| Self-reported anxiety | Change in total score on the Geriatric Anxiety Scale | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | 
| Self-reported quality of life | Change in total score on the Quality of Life in Alzheimer's Disease | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | 
| Self-reported quality of well-being | Change in total score on the Quality of Well-Being Scale - Self-Administered | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | 
| Functional neuroimaging | Change in total scores from memory task during fMRI scan | two points in time: pre-treatment and immediately following treatment | 
| Functional memory | Change in total score from Virtual Reality Functional Capacity Assessment Tool (VRF-CAT) | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | 
| Story memory | Change in total score from Prose Memory Test | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Memory, learning, rehabilitation, aging, cognition