Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Kessler Foundation
Study ID
NCT05396248
Status
Recruiting
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Conditions

  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Jun 28, 2023
Status verified
May 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).
  • 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).

Primary Outcome Measure

Verbal list learning [ Time Frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48105
Eileen Robinson
[email protected]
734-763-1356
Kessler Foundation Research CenterWest OrangeNew Jersey07052
Nancy B Moore, MA
[email protected]
973-324-8450
Nancy D Chiaravalloti, PhD
[email protected]
973-324-8440
Nancy D Chiaravalloti, PhD (PRINCIPAL_INVESTIGATOR)

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