Clinical trial NCT05396248: Improve New Learning and Memory in Individuals With Mild Cognitive Impairment
Official title: Use of a Memory Technique to Improve New Learning and Memory in Individuals With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Memory
learning
rehabilitation
aging
cognition
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Michigan State University
First posted: 2022-05-31
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Verbal list learning
timeFrame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
measure: Participation in everyday life
timeFrame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Secondary outcomes:
measure: Self-reported depression
timeFrame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
measure: Self-reported anxiety
timeFrame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
measure: Self-reported quality of life
timeFrame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
measure: Self-reported quality of well-being
timeFrame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
measure: Functional neuroimaging
timeFrame: two points in time: pre-treatment and immediately following treatment
measure: Functional memory
timeFrame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
measure: Functional memory
timeFrame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
measure: Story memory
timeFrame: four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: West Orange
country: United States
facility: Kessler Foundation Research Center
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Nancy Chiaravalloti
role: PRINCIPAL_INVESTIGATOR
References: