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Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor 2 versions Re-verified since May 13, 2025, no change to tracked fieldsv7-v8
  2. Notable Start date: May 17, 2023 to Jun 28, 2023
    • Secondary endpoints: 7 to 8
    v6
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2023 to May 17, 2023
    • Site details revised at 2 of 2 sites
    v5
  4. Notable Start date: Dec 2022 to Feb 2023v4
  5. Notable Start date: Sep 2022 to Dec 2022v3
  6. Notable Start date: Jul 2022 to Sep 2022v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05396248
Lead Sponsor Kessler Foundation
Collaborators: University of Michigan, Michigan State University
Conditions
(from sponsor)
Mild Cognitive Impairment
Related terms Cognitive Dysfunction
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov