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Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Memory Retraining Exercises
Placebo Control Memory Exercises
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Memory, learning, rehabilitation, aging, cognition

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of MichiganRecruiting
  • Kessler Foundation Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Placebo Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Verbal list learning
Change in total score from Open-Trial Selective Reminding Test (OT-SRT)
Participation in everyday life
Change in total score from Participation Assessment with Recombined Tools

Secondary Outcome Measures

Self-reported depression
Change in total score on the Geriatric Depression Scale
Self-reported anxiety
Change in total score on the Geriatric Anxiety Scale
Self-reported quality of life
Change in total score on the Quality of Life in Alzheimer's Disease
Self-reported quality of well-being
Change in total score on the Quality of Well-Being Scale - Self-Administered
Functional neuroimaging
Change in total scores from memory task during fMRI scan
Functional memory
Change in total score from Virtual Reality Functional Capacity Assessment Tool (VRF-CAT)
Story memory
Change in total score from Prose Memory Test

Full Information

First Posted
May 18, 2022
Last Updated
October 3, 2023
Sponsor
Kessler Foundation
Collaborators
University of Michigan, Michigan State University
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1. Study Identification

Unique Protocol Identification Number
NCT05396248
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
University of Michigan, Michigan State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Memory, learning, rehabilitation, aging, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for five weeks (10 training sessions).
Arm Title
Placebo Control Group
Arm Type
Placebo Comparator
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
Memory Retraining Exercises
Intervention Description
Memory retraining exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
Intervention Type
Behavioral
Intervention Name(s)
Placebo Control Memory Exercises
Intervention Description
Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 training sessions).
Primary Outcome Measure Information:
Title
Verbal list learning
Description
Change in total score from Open-Trial Selective Reminding Test (OT-SRT)
Time Frame
four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Title
Participation in everyday life
Description
Change in total score from Participation Assessment with Recombined Tools
Time Frame
four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Secondary Outcome Measure Information:
Title
Self-reported depression
Description
Change in total score on the Geriatric Depression Scale
Time Frame
four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Title
Self-reported anxiety
Description
Change in total score on the Geriatric Anxiety Scale
Time Frame
four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Title
Self-reported quality of life
Description
Change in total score on the Quality of Life in Alzheimer's Disease
Time Frame
four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Title
Self-reported quality of well-being
Description
Change in total score on the Quality of Well-Being Scale - Self-Administered
Time Frame
four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Title
Functional neuroimaging
Description
Change in total scores from memory task during fMRI scan
Time Frame
two points in time: pre-treatment and immediately following treatment
Title
Functional memory
Description
Change in total score from Virtual Reality Functional Capacity Assessment Tool (VRF-CAT)
Time Frame
four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed
Title
Story memory
Description
Change in total score from Prose Memory Test
Time Frame
four points in time: pre-treatment, immediately following treatment, and 6- and 18- months after treatment is completed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Moore
Phone
1973-324-8450
Email
nbmoore@kesslerfoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Chiaravalloti
Phone
973-324-8440
Email
nchiaravalloti@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Chiaravalloti
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen Robinson
Phone
734-763-1356
Email
robinsoe@med.umich.edu
Facility Name
Kessler Foundation Research Center
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy B Moore, MA
Phone
973-324-8450
Email
nbmoore@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Nancy D Chiaravalloti, PhD
Phone
973-324-8440
Email
nchiaravalloti@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Nancy D Chiaravalloti, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Improve New Learning and Memory in Individuals With Mild Cognitive Impairment

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