NCT02301546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

June 9, 2020

Completed
Last Updated

June 9, 2020

Status Verified

May 1, 2020

Enrollment Period

4.9 years

First QC Date

November 21, 2014

Results QC Date

April 28, 2020

Last Update Submit

May 28, 2020

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • 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.

    13 weeks

Study Arms (2)

experimental cognitive training

EXPERIMENTAL

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

Behavioral: computerized cognitive exercises

control cognitive exercises

ACTIVE COMPARATOR

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

Behavioral: computerized cognitive exercises

Interventions

computerized cognitive exercisesBEHAVIORAL

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.

control cognitive exercisesexperimental cognitive training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Mild Cognitive Impairment, amnestic subtype
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

  • 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.

    PMID: 33783254DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Limitations and Caveats

underpowered

Results Point of Contact

Title
Kevin Duff
Organization
University of Utah
kevin.duff@hsc.utah.edu
8015859983

Study Officials

  • Kevin Duff, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

November 21, 2014

First Posted

November 26, 2014

Study Start

March 1, 2015

Primary Completion

January 28, 2020

Study Completion

February 28, 2020

Last Updated

June 9, 2020

Results First Posted

June 9, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Other researchers can contact the PI to request copies of the study data.

Locations

US(1)