Mild Cognitive ImpairmentNCT02588209
Cognitive Screening and Cognitive Training in Seniors
A study testing Strategic Memory Advanced Reasoning Training and Brain Health Workshop in people with Mild Cognitive Impairment, run by The University of Texas at Dallas at 1 site in United States.
Trial summary
This study will provide cognitive screenings for seniors age 50 and older. It will also investigate the benefits of two different cognitive training programs for seniors who have lower baseline performance on memory and/or gist reasoning tests. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Strategic Memory Advanced Reasoning Training and Brain Health Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cognitive complaints in the absence of dementia
- Participate in tasks involving motor abilities such as use of at least one arm and hand
- Read, speak, and comprehend English
- At least 50 years of age
- Comprehend simple instructions, perform tasks, and take part in intervention
Who cannot join
- Not proficient in reading,comprehending, and speaking English
- History of learning disability, stroke, cognitive impairment, major psychiatric illness, alcoholism, or substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
This study will provide cognitive screenings for seniors age 50 and older. It will also investigate the benefits of two different cognitive training programs for seniors who have lower baseline performance on memory and/or gist reasoning tests.
Read the detailed description
This study consists of two parts which includes cognitive screening and cognitive training. Participants will initially participate in the cognitive screening portion of the study. If qualified, participants will participate in the cognitive training portion of this study which includes additional cognitive communication, neuropsychological testing, and EEG.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Strategic Memory Advanced Reasoning Training, Brain Health Workshop
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategic Memory Advanced Reasoning TrainingBehavioural
Also called SMART
SMART teaches strategies to improve the ability to process information.
Brain Health WorkshopBehavioural
Brain Health Workshop provides information about brain health in a seminar format. Topics include: sleep, nutrition, and exercise.
| Study group | Role | What they receive |
|---|---|---|
| SMART Training | Experimental | This group will receive the Strategic Memory Advanced Reasoning Training (SMART) program, twice a week for four weeks. Receives: Behavioral: Strategic Memory Advanced Reasoning Training |
| Health | Active comparator | This group will receive the Brain Health Workshop educational program, twice a week for four weeks. Receives: Behavioral: Brain Health Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in memory or thinking after brain training
To examine short-term effects of treatment on cognition using neuropsychological measures
Measured: beginning (0 weeks) to end (4 weeks)
Secondary outcomes (1)
Measures changes in brain wave activity
Electrophysiological responses will be recorded using event related potential to monitor responses to yes/no stimuli.
Measured: beginning (0 weeks) and end (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Chapman, PhD, Principal investigator, Center for Brain Health, University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588209
- Sponsor's protocol ID
- RGK11-52
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2015
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Mudar RA, Nguyen LT, Eroh J, Chiang HS, Rackley A, Chapman SB. Event-related neural oscillation changes following reasoning training in individuals with Mild Cognitive Impairment. Brain Res. 2019 Feb 1;1704:229-240. doi: 10.1016/j.brainres.2018.10.017. Epub 2018 Oct 17.
PubMed 30342001
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Screening and Cognitive Training in Seniors
- ClinicalTrials.gov ID
- NCT02588209
- Acronym / sponsor ID
- RGK11-52
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide cognitive screenings for seniors age 50 and older. It will also investigate the benefits of two different cognitive training programs for seniors who have lower baseline performance on memory and/or gist reasoning tests.
Detailed description
This study consists of two parts which includes cognitive screening and cognitive training. Participants will initially participate in the cognitive screening portion of the study. If qualified, participants will participate in the cognitive training portion of this study which includes additional cognitive communication, neuropsychological testing, and EEG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART Training | Experimental | Behavioral: Strategic Memory Advanced Reasoning TrainingThis group will receive the Strategic Memory Advanced Reasoning Training (SMART) program, twice a week for four weeks. |
| Health | Active comparator | Behavioral: Brain Health WorkshopThis group will receive the Brain Health Workshop educational program, twice a week for four weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cognitive complaints in the absence of dementia
- Participate in tasks involving motor abilities such as use of at least one arm and hand
- Read, speak, and comprehend English
- At least 50 years of age
- Comprehend simple instructions, perform tasks, and take part in intervention
Key exclusion criteria (2 listed)
- Not proficient in reading,comprehending, and speaking English
- History of learning disability, stroke, cognitive impairment, major psychiatric illness, alcoholism, or substance abuse
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 |
|---|---|---|
| Strategic Memory Advanced Reasoning TrainingAlso: SMARTSMART teaches strategies to improve the ability to process information. | Behavioural | SMART Training |
| Brain Health WorkshopBrain Health Workshop provides information about brain health in a seminar format. Topics include: sleep, nutrition, and exercise. | Behavioural | Health |
Primary outcome
Improvement in memory or thinking after brain training
Time frame: beginning (0 weeks) to end (4 weeks)
To examine short-term effects of treatment on cognition using neuropsychological measures
1 secondary outcome
Measures changes in brain wave activity
Time frame: beginning (0 weeks) and end (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Derived from this study: PubMed 30342001Mudar RA, Nguyen LT, Eroh J, Chiang HS, Rackley A, Chapman SB. Event-related neural oscillation changes following reasoning training in individuals with Mild Cognitive Impairment. Brain Res. 2019 Feb 1;1704:229-240. doi: 10.1016/j.brainres.2018.10.017. Epub 2018 Oct 17.
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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.
Sandra Chapman, PhD principal investigator
Center for Brain Health, University of Texas at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategic Memory Advanced Reasoning Training and Brain Health Workshop in people with Mild Cognitive Impairment, run by The University of Texas at Dallas 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 2 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 30 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in memory or thinking after brain training (time frame: beginning (0 weeks) to end (4 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 NCT02588209, 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 30 Oct 2023.