Improve New Learning and Memory in Individuals With Mild Cognitive Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Memory Retraining Exercises, Placebo Control Memory Exercises.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of a Memory Technique to Improve New Learning and Memory in Individuals With Mild Cognitive Impairment
Overview
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
- Behavioral Memory Retraining Exercises
Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions). - Behavioral 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 measures
- 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]
Secondary outcome measures (8)
- Self-reported depression [Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
- Self-reported anxiety [Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
- Self-reported quality of life [Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
- Self-reported quality of well-being [Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
- Functional neuroimaging [Time frame: two points in time: pre-treatment and immediately following treatment]
- Functional memory [Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
- Functional memory [Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
- Story memory [Time frame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Michigan — Ann Arbor
- Kessler Foundation Research Center — West Orange
Identifiers
NCT: NCT05396248 · R-1183-22