Recruiting

Cognitive Enhancement

Sponsor:

Kessler Foundation

Code:

NCT05396248

Conditions

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Memory Retraining Exercises

Placebo Control Memory Exercises

Study Details

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

Study ID

NCT05396248

Start date

Jun 28, 2023

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Memory Retraining Exercises

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

Placebo Control Memory Exercises

Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training 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 ]
  • Participation in everyday life [ Time Frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed ]

Central Contacts and Locations

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Kessler Foundation Research Center

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Principal Investigator:

Nancy D Chiaravalloti, PhD

More Information

Sponsor

Kessler Foundation

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Memory
  • learning
  • rehabilitation
  • aging
  • cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2026-07-22.