Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Memory Retraining Exercises; Behavioral: Placebo Control Memory Exercises

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nancy Moore; Phone Number: 1973-324-8450; Email: nbmoore@kesslerfoundation.org
• Study Contact Backup: Name: Nancy Chiaravalloti; Phone Number: 973-324-8440; Email: nchiaravalloti@kesslerfoundation.org

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Recruiting
      • University of Michigan
      • Contact: Eileen Robinson; Phone Number: 734-763-1356; Email: robinsoe@med.umich.edu
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Kessler Foundation Research Center
      • Contact: Nancy B Moore, MA; Phone Number: 973-324-8450; Email: nbmoore@kesslerfoundation.org
      • Principal Investigator: Nancy D Chiaravalloti, PhD
      • Contact: Nancy D Chiaravalloti, PhD; Phone Number: 973-324-8440; Email: nchiaravalloti@kesslerfoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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; Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
Placebo Comparator: Placebo Control Group; 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; Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).

What is the study measuring?

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
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
Functional memory	Change in total score from Object Location Task	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Functional memory	Change in total score from the modified Everyday Memory Scenarios (EMS)	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: University of Michigan; Michigan State University
• Investigators: Principal Investigator: Nancy Chiaravalloti, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; cognition; aging; Memory; learning
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: R-1183-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No