- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02301546
Cognitive Training and Practice Effects in Mild Cognitive Impairment
May 28, 2020 updated by: Kevin Duff, University of Utah
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
197
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
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Salt Lake City, Utah, United States, 84108
- University of Utah Center for Alzheimer's Care, Imaging and Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental cognitive training
Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks.
|
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.
|
|
Active Comparator: control cognitive exercises
Participants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Auditory Memory Attention Index
Time Frame: 13 weeks
|
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.
|
13 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kevin Duff, PhD, University of Utah
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2015
Primary Completion (Actual)
January 28, 2020
Study Completion (Actual)
February 28, 2020
Study Registration Dates
First Submitted
November 21, 2014
First Submitted That Met QC Criteria
November 24, 2014
First Posted (Estimate)
November 26, 2014
Study Record Updates
Last Update Posted (Actual)
June 9, 2020
Last Update Submitted That Met QC Criteria
May 28, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AG045163 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Other researchers can contact the PI to request copies of the study data.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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