Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Kessler Foundation

Status: Enrolling

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Placebo Control Memory Exercises; Behavioral: Memory Retraining Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT05396248

R-1183-22

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for five weeks (10 training sessions).

Treatment:

Behavioral: Memory Retraining Exercises

Placebo Control Group

Placebo Comparator group

Description:

The placebo control group will receive placebo memory exercises administered on a laptop computer twice a week for five weeks (10 placebo control sessions).

Treatment:

Behavioral: Placebo Control Memory Exercises