Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT05396248

Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Led by Kessler Foundation · Updated on 2025-05-16

120

Participants Needed

2

Research Sites

191 weeks

Total Duration

On this page

Sponsors

K

Kessler Foundation

Lead Sponsor

U

University of Michigan

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 60 or older.
  • read and speak English fluently.
  • Research based diagnosis of Amnestic Mild Cognitive Impairment
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University of Michigan

Ann Arbor, Michigan, United States, 48105

Actively Recruiting

2

Kessler Foundation Research Center

West Orange, New Jersey, United States, 07052

Actively Recruiting

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Research Team

N

Nancy Moore

CONTACT

N

Nancy Chiaravalloti

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Improve New Learning and Memory in Individuals With Mild Cognitive Impairment | DecenTrialz