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NCT Number: NCT05396248

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

memory retraining exercises

Behavioral

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

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).

Primary outcomes

  1. Verbal list learning

    Time frame: 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)

  2. Participation in everyday life

    Time frame: 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 outcomes

  1. Self-reported depression

    Time frame: 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

  2. Self-reported anxiety

    Time frame: 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

  3. Self-reported quality of life

    Time frame: 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

  4. Self-reported quality of well-being

    Time frame: 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

  5. Functional neuroimaging

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

    Change in total scores from memory task during fMRI scan

  6. Functional memory

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

    Change in total score from Object Location Task

  7. Functional memory

    Time frame: 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)

  8. Story memory

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nancy Chiaravalloti

CONTACT

[email protected]

973-324-8440

Nancy Moore

CONTACT

[email protected]

1973-324-8450

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • Michigan State University
  • University of Michigan

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 31, 2022
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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