HIV InfectionNCT02602418
Neural Correlates of Working Memory Training for HIV Patients
A study testing Adaptive WM CogMed Training and Nonadaptive WM CogMed Training in people with HIV Infection, run by University of Hawaii at 1 site in United States.
Trial summary
Despite potent combination antiretroviral therapy, cognitive (memory and concentration) problems continue to occur in up to 50% of HIV-infected individuals, especially in older infected individuals, and those who abuse alcohol, marijuana or psychostimulants. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Adaptive WM CogMed Training and Nonadaptive WM CogMed Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to May 2020
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women of any ethnicity, ages>18 years and able to provide informed consent,
- HIV seropositive (with documentation from medical records),
- Stable on an antiretroviral regimen for 6 months or will remain without antiretroviral treatment during the duration of the study.
- Inclusion Criteria for Seronegative (SN) healthy participants :
- Men or women of any ethnicity, ages > 18 years and able to give informed consent,
- Seronegative for HIV
Who cannot join
- Confounding co-morbid psychiatric illness
- Confounding neurological disorders
- Abnormal screening laboratory tests (>2 SD) that might indicate a chronic medical condition (e.g. diabetes, severe cardiac, renal or liver disorders)
- Medications that might influence outcome measures
- Current or history of drug dependence within the past two years
- Positive urine toxicology screen
- Inability to read at an 8th grade level
- Other contraindications for MR studies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine
Baltimore, Maryland, 21201
About this study
Official title: Neural Correlates of Working Memory Training for HIV Patients: A Randomized Control Clinical Trial
Despite potent combination antiretroviral therapy, cognitive (memory and concentration) problems continue to occur in up to 50% of HIV-infected individuals, especially in older infected individuals, and those who abuse alcohol, marijuana or psychostimulants. Since no effective treatments are available to these individuals with cognitive problems, conservative estimates indicate that the cost of care for these patients could double in the next two decades. To address this urgent problem, this study will use a comprehensive approach (cognitive tests, functional MRI and several biomarkers) to evaluate whether a novel computer-based training program would improve the brain function, especially working memory and attention, in HIV-infected and infected individuals.
Read the detailed description
The Overall Goals are to perform a double blind placebo-controlled study using Cogmed™ to determine whether this adaptive WM training program will benefit HIV-infected individuals, and whether the investigators can identify individuals who might benefit most from the working memory (WM) training. Lastly, the investigators will explore how brain activation, neuroinflammation and cerebrospinal fluid (CSF) monoamine levels might be related to WM function before and after the training.
- Conditions
- HIV Infection
- Being tested
- Adaptive WM CogMed Training, Nonadaptive WM CogMed Training
- Keywords
- Human Immunodeficiency Virus (HIV), working memory training, brain function, functional magnetic resonance imaging (fMRI)
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive WM CogMed TrainingOther
12 different computerized visual and spatial Working Memory tasks will be presented at each sessoin. Each session will involve 8 of the 12 tasks, and each subject is required to complete 25 training sessions, 30-40 minutes per day, 4-5 days per week over a 5-8 week period (minimum 20 sessions). The tasks will become more difficult in an "adaptive" manner, which is hypothesized as optimal for learning and training effects.
Nonadaptive WM CogMed TrainingOther
The same 12 computerized visual and spatial working memory tasks will be presented, but at a fixed ("non-adaptive") and low difficulty level. 5 sessions per week x 5 weeks fora total of 25 sessions (minimum 20 sessions).
| Study group | Role | What they receive |
|---|---|---|
| HIV Positive participants | Experimental | Intervention; 90 HIV positive participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training. Receives: Other: Adaptive WM CogMed Training; Other: Nonadaptive WM CogMed Training |
| Seronegative particpiants | Other | Intervention; 90 seronegative participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training. Receives: Other: Adaptive WM CogMed Training; Other: Nonadaptive WM CogMed Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Improvement Index on Cogmed™
This is generated by the computer training program based on the trained tasks.
Measured: 1 month after training, and 6 month after training completion
Changes in Performances on near transfer working memory tasks
Verbal working memory and spatial working memory tasks
Measured: 1 month after training, and 6 month after training completion
Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures
Brain activation during the performance of working memory and attention tasks
Measured: 1 month after training, and 6 month after training completion
Secondary outcomes (3)
Changes in cognitive performance based on LIM homeobox transcription factor 1 alpha (LMX1A) genotypes (AA vs. GA/GG)
Performance and improvements on cognitive tests may vary at baseline and after training based on LMX1A genotypes
Measured: Baseline, 1 month after training, and 6 month after training completion
Changes in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Improvement on BRIEF-A, a self-reported evaluation of the person's executive function during their activities of daily living.
Measured: 1 month after training, and 6 month after training completion
Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures based on LMX1A genotypes
Brain activation during working memory performance may vary at baseline, 1-month or 6-months based on the different LMX1A genotypes
Measured: 1 month after training, and 6 month after training completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startSep 2012
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Maryland, Baltimore
- Responsible party
- Principal investigator, Linda Chang, M.D., University of Maryland, College Park
- Investigators
- Linda Chang, MD, Principal investigator, University of Maryland Baltimiore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602418
- Sponsor's protocol ID
- 4R01DA035659-04
- Other IDs
- 4R01DA035659-04
- Status last verified
- Oct 2019
- First submitted
- 5 Nov 2015
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chang L, Liang H, Ernst T, Cunningham E, Wang J, Baptiste J, Lohaugen GCC. LMX1A and APOE varepsilon Genotype Associations With Working Memory Training Effects in HIV and Non-HIV: A Randomized Controlled Trial. Neurol Neuroimmunol Neuroinflamm. 2026 Jan;13(1):e200519. doi: 10.1212/NXI.0000000000200519. Epub 2025 Dec 11.
PubMed 41380114Chang L, Lohaugen GC, Douet V, Miller EN, Skranes J, Ernst T. Neural correlates of working memory training in HIV patients: study protocol for a randomized controlled trial. Trials. 2016 Feb 2;17:62. doi: 10.1186/s13063-016-1160-4.
PubMed 26833223
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Working Memory Training for HIV Patients: A Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT02602418
- Acronym / sponsor ID
- 4R01DA035659-04
- Conditions
- HIV Infection
- Keywords
- Human Immunodeficiency Virus (HIV), working memory training, brain function, functional magnetic resonance imaging (fMRI)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Maryland, Baltimore
- Study start
- Sep 2012 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 11 Nov 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.
Despite potent combination antiretroviral therapy, cognitive (memory and concentration) problems continue to occur in up to 50% of HIV-infected individuals, especially in older infected individuals, and those who abuse alcohol, marijuana or psychostimulants. Since no effective treatments are available to these individuals with cognitive problems, conservative estimates indicate that the cost of care for these patients could double in the next two decades. To address this urgent problem, this study will use a comprehensive approach (cognitive tests, functional MRI and several biomarkers) to evaluate whether a novel computer-based training program would improve the brain function, especially working memory and attention, in HIV-infected and infected individuals.
Detailed description
The Overall Goals are to perform a double blind placebo-controlled study using Cogmed™ to determine whether this adaptive WM training program will benefit HIV-infected individuals, and whether the investigators can identify individuals who might benefit most from the working memory (WM) training. Lastly, the investigators will explore how brain activation, neuroinflammation and cerebrospinal fluid (CSF) monoamine levels might be related to WM function before and after the training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV Positive participants | Experimental | Other: Adaptive WM CogMed Training, Other: Nonadaptive WM CogMed TrainingIntervention; 90 HIV positive participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training. |
| Seronegative particpiants | Other | Other: Adaptive WM CogMed Training, Other: Nonadaptive WM CogMed TrainingIntervention; 90 seronegative participants will be trained. Half the participants will have the Adaptive WM Cogmed training, and half will have the non-adaptive WM Cogmed training. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women of any ethnicity, ages>18 years and able to provide informed consent,
- HIV seropositive (with documentation from medical records),
- Stable on an antiretroviral regimen for 6 months or will remain without antiretroviral treatment during the duration of the study.
- Men or women of any ethnicity, ages > 18 years and able to give informed consent,
- Seronegative for HIV
Key exclusion criteria (8 listed)
- Confounding co-morbid psychiatric illness
- Confounding neurological disorders
- Abnormal screening laboratory tests (>2 SD) that might indicate a chronic medical condition (e.g. diabetes, severe cardiac, renal or liver disorders)
- Medications that might influence outcome measures
- Current or history of drug dependence within the past two years
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 |
|---|---|---|
| Adaptive WM CogMed Training12 different computerized visual and spatial Working Memory tasks will be presented at each sessoin. Each session will involve 8 of the 12 tasks, and each subject is required to complete 25 training sessions, 30-40 minutes per day, 4-5 days per week over a 5-8 week period (minimum 20 sessions). The tasks will become more difficult in an "adaptive" manner, which is hypothesized as optimal for learning and training effects. | Other | HIV Positive participants, Seronegative particpiants |
| Nonadaptive WM CogMed TrainingThe same 12 computerized visual and spatial working memory tasks will be presented, but at a fixed ("non-adaptive") and low difficulty level. 5 sessions per week x 5 weeks fora total of 25 sessions (minimum 20 sessions). | Other | HIV Positive participants, Seronegative particpiants |
Primary outcome
Changes in the Improvement Index on Cogmed™
Time frame: 1 month after training, and 6 month after training completion
This is generated by the computer training program based on the trained tasks.
Changes in Performances on near transfer working memory tasks
Time frame: 1 month after training, and 6 month after training completion
Verbal working memory and spatial working memory tasks
Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures
Time frame: 1 month after training, and 6 month after training completion
Brain activation during the performance of working memory and attention tasks
3 secondary outcomes
Changes in cognitive performance based on LIM homeobox transcription factor 1 alpha (LMX1A) genotypes (AA vs. GA/GG)
Time frame: Baseline, 1 month after training, and 6 month after training completion
Changes in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Time frame: 1 month after training, and 6 month after training completion
Changes in Blood-Oxygenation Level-Dependent Functional MRI Measures based on LMX1A genotypes
Time frame: 1 month after training, and 6 month after training completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Derived from this study: PubMed 41380114Chang L, Liang H, Ernst T, Cunningham E, Wang J, Baptiste J, Lohaugen GCC. LMX1A and APOE varepsilon Genotype Associations With Working Memory Training Effects in HIV and Non-HIV: A Randomized Controlled Trial. Neurol Neuroimmunol Neuroinflamm. 2026 Jan;13(1):e200519. doi: 10.1212/NXI.0000000000200519. Epub 2025 Dec 11.
- Derived from this study: PubMed 26833223Chang L, Lohaugen GC, Douet V, Miller EN, Skranes J, Ernst T. Neural correlates of working memory training in HIV patients: study protocol for a randomized controlled trial. Trials. 2016 Feb 2;17:62. doi: 10.1186/s13063-016-1160-4.
- Individual participant dataSharing planned: No
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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.
Linda Chang, MD principal investigator
University of Maryland Baltimiore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive WM CogMed Training and Nonadaptive WM CogMed Training in people with HIV Infection, run by University of Hawaii 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 2 Oct 2019. 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?
Results are not available in the source record.
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?
Changes in the Improvement Index on Cogmed™ (time frame: 1 month after training, and 6 month after training completion). The study lists 3 primary outcomes in all. 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 NCT02602418, which also lists 2 linked publications.
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 2 Oct 2019.