Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Use of a Memory Technique to Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396248
• Other study ID #: R-1183-22
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: March 2027

Study information

• Verified date: March 2024
• Source: Kessler Foundation
• Contact: Nancy Moore
• Phone: 1973-324-8450
• Email: nbmoore[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Memory Retraining Exercises
Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
• Placebo Control Memory Exercises
Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Kessler Foundation Research Center	West Orange	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Kessler Foundation	Michigan State University, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verbal list learning	Change in total score from Open-Trial Selective Reminding Test (OT-SRT)	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Primary	Participation in everyday life	Change in total score from Participation Assessment with Recombined Tools	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Secondary	Self-reported depression	Change in total score on the Geriatric Depression Scale	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Secondary	Self-reported anxiety	Change in total score on the Geriatric Anxiety Scale	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Secondary	Self-reported quality of life	Change in total score on the Quality of Life in Alzheimer's Disease	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Secondary	Self-reported quality of well-being	Change in total score on the Quality of Well-Being Scale - Self-Administered	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Secondary	Functional neuroimaging	Change in total scores from memory task during fMRI scan	two points in time: pre-treatment and immediately following treatment
Secondary	Functional memory	Change in total score from Object Location Task	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Secondary	Functional memory	Change in total score from the modified Everyday Memory Scenarios (EMS)	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Secondary	Story memory	Change in total score from Prose Memory Test	four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed