Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorKessler Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

60 or older.

read and speak English fluently.

Research based diagnosis of Amnestic Mild Cognitive Impairment

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Placebo Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Verbal list learning

Change in total score from Open-Trial Selective Reminding Test (OT-SRT)

Time frame
four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
2

Participation in everyday life

Change in total score from Participation Assessment with Recombined Tools

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

Secondary outcomes

1

Self-reported depression

Change in total score on the Geriatric Depression Scale

Time frame
four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
2

Self-reported anxiety

Change in total score on the Geriatric Anxiety Scale

Time frame
four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
3

Self-reported quality of life

Change in total score on the Quality of Life in Alzheimer's Disease

Time frame
four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
4

Self-reported quality of well-being

Change in total score on the Quality of Well-Being Scale - Self-Administered

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kessler Foundation

Lead sponsor

University of Michigan

Collaborator

Michigan State University

Collaborator