Mild Cognitive ImpairmentNCT02301546
Cognitive Training and Practice Effects in Mild Cognitive Impairment
A study testing computerized cognitive exercises in people with Mild Cognitive Impairment, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- computerized cognitive exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Center for Alzheimer's Care, Imaging and Research
Salt Lake City, Utah, 84108
About this study
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- computerized cognitive exercises
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized cognitive exercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental cognitive training | Experimental | Participants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. Receives: 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. Receives: Behavioral: computerized cognitive exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startMar 2015
- Primary completion28 Jan 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kevin Duff, University of Utah
- Investigators
- Kevin Duff, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301546
- Sponsor's protocol ID
- R01AG045163
- Other IDs
- R01AG045163
- Status last verified
- May 2020
- First submitted
- 21 Nov 2014
- Last updated
- 9 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Other researchers can contact the PI to request copies of the study data.
Publications
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.
PubMed 33783254
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training and Practice Effects in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02301546
- Acronym / sponsor ID
- R01AG045163
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Mar 2015 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental cognitive training | Experimental | Behavioral: computerized cognitive exercisesParticipants will use experimental computerized cognitive training exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. |
| control cognitive exercises | Active comparator | Behavioral: computerized cognitive exercisesParticipants will use control computerized cognitive activities, 1 hour per day, 3 - 5 days per week, for 13 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Mild Cognitive Impairment, amnestic subtype
- Access to internet 3 hours per week
- Adequate vision, hearing, and motor responding to participate in training
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computerized cognitive exercisesEach 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. | Behavioural | control cognitive exercises, experimental cognitive training |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33783254Duff 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.
- Individual participant dataSharing planned: No. Other researchers can contact the PI to request copies of the study data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Duff, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computerized cognitive exercises in people with Mild Cognitive Impairment, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory Memory Attention Index (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.