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Cognitive Training and Practice Effects in Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
computerized cognitive exercises
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mild Cognitive Impairment, amnestic subtype

    • 65 years of age or older
    • Availability of a knowledgeable informant
  • Access to internet 3 hours per week
  • Adequate vision, hearing, and motor responding to participate in training

Exclusion Criteria:

  • History of major stroke, head injury with loss of consciousness of >30 minutes, or other neurological disorder or systemic illness that are thought to be affecting cognition (e.g., seizure disorder, demyelinating disorder, etc.)
  • Current or past major psychiatric illness (e.g., schizophrenia, bipolar affective disorder)
  • History of substance abuse
  • Current use of antipsychotics or anticonvulsant medications
  • Currently residing in a nursing home or other skilled nursing facility

Sites / Locations

  • University of Utah Center for Alzheimer's Care, Imaging and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental cognitive training

control cognitive exercises

Arm Description

Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks.

Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks.

Outcomes

Primary Outcome Measures

Auditory Memory Attention Index
This is a composite of six subtests of the Repeatable Battery for the Assessment of Neuropsychological Status. It is a standard score (mean=100, standard deviation=15), with a range of approximately 45 - 145, with higher scores indicating better outcome.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2014
Last Updated
May 28, 2020
Sponsor
University of Utah
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02301546
Brief Title
Cognitive Training and Practice Effects in Mild Cognitive Impairment
Official Title
Cognitive Training and Practice Effects in Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
January 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The current study will test the effectiveness of a computerized cognitive training program on auditory memory and attention in patients with mild cognitive impairment. Practice effects will also be examined as a moderator of treatment response.
Detailed Description
The current study will test the effectiveness of a computerized cognitive (thinking) training program on improving thinking and memory in patients with mild cognitive impairment. The investigators will also examine how short term changes in thinking abilities (i.e., practice effects) can be related to improvement in thinking abilities after the cognitive training program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental cognitive training
Arm Type
Experimental
Arm Description
Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks.
Arm Title
control cognitive exercises
Arm Type
Active Comparator
Arm Description
Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks.
Intervention Type
Behavioral
Intervention Name(s)
computerized cognitive exercises
Intervention Description
Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings.
Primary Outcome Measure Information:
Title
Auditory Memory Attention Index
Description
This is a composite of six subtests of the Repeatable Battery for the Assessment of Neuropsychological Status. It is a standard score (mean=100, standard deviation=15), with a range of approximately 45 - 145, with higher scores indicating better outcome.
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mild Cognitive Impairment, amnestic subtype 65 years of age or older Availability of a knowledgeable informant Access to internet 3 hours per week Adequate vision, hearing, and motor responding to participate in training Exclusion Criteria: History of major stroke, head injury with loss of consciousness of >30 minutes, or other neurological disorder or systemic illness that are thought to be affecting cognition (e.g., seizure disorder, demyelinating disorder, etc.) Current or past major psychiatric illness (e.g., schizophrenia, bipolar affective disorder) History of substance abuse Current use of antipsychotics or anticonvulsant medications Currently residing in a nursing home or other skilled nursing facility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Duff, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Center for Alzheimer's Care, Imaging and Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Other researchers can contact the PI to request copies of the study data.
Citations:
PubMed Identifier
33783254
Citation
Duff K, Ying J, Suhrie KR, Dalley BCA, Atkinson TJ, Porter SM, Dixon AM, Hammers DB, Wolinsky FD. Computerized Cognitive Training in Amnestic Mild Cognitive Impairment: A Randomized Clinical Trial. J Geriatr Psychiatry Neurol. 2022 May;35(3):400-409. doi: 10.1177/08919887211006472. Epub 2021 Mar 30.
Results Reference
derived

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Cognitive Training and Practice Effects in Mild Cognitive Impairment

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