Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

NCT05396248 | Recruiting DMC

• 1 other identifier: R-1183-22
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment

Keywords

Memory; learning; rehabilitation; aging; cognition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Self-reported depression

  four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed

• Self-reported anxiety

  four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed

• Self-reported quality of life

  four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed

• Self-reported quality of well-being

  four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed

• Functional neuroimaging

  two points in time: pre-treatment and immediately following treatment

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Placebo Control Group

PLACEBO COMPARATOR

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

Interventions

Memory Retraining Exercises BEHAVIORAL

Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).

Experimental Group

Placebo Control Memory Exercises BEHAVIORAL

Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).

Placebo Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead
• University of Michigan: collaborator
• Michigan State University: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48105, United States

RECRUITING

Kessler Foundation Research Center

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Nancy Chiaravalloti

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Moore

CONTACT

1973-324-8450; nbmoore@kesslerfoundation.org

Nancy Chiaravalloti

CONTACT

973-324-8440; nchiaravalloti@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 31, 2022
• Study Start: June 28, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

US (2)