Mild Cognitive Impairment
Conditions
Keywords
Memory, learning, rehabilitation, aging, cognition
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.
Interventions
BEHAVIORALMemory Retraining Exercises
Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
BEHAVIORALPlacebo Control Memory Exercises
Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
Sponsors
Kessler Foundation
University of Michigan
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal list learning | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | Change in total score from Open-Trial Selective Reminding Test (OT-SRT) |
| Participation in everyday life | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | Change in total score from Participation Assessment with Recombined Tools |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported depression | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | Change in total score on the Geriatric Depression Scale |
| Self-reported anxiety | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | Change in total score on the Geriatric Anxiety Scale |
| Self-reported quality of life | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | Change in total score on the Quality of Life in Alzheimer's Disease |
| Self-reported quality of well-being | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | Change in total score on the Quality of Well-Being Scale - Self-Administered |
| Functional neuroimaging | two points in time: pre-treatment and immediately following treatment | Change in total scores from memory task during fMRI scan |
| Functional memory | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | Change in total score from Object Location Task |
| Story memory | four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed | Change in total score from Prose Memory Test |
Countries
United States
Contacts
CONTACTNancy Moore
CONTACTNancy Chiaravalloti
PRINCIPAL_INVESTIGATORNancy Chiaravalloti
Kessler Foundation
Outcome results
None listed