Cognitive ChangeEarly Phase 1NCT06699927

Working Memory Training for People Aging With HIV

A Early Phase 1 study testing Span in people with Cognitive Change, run by Northeastern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Cognitive Change
What is being tested?: Span
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 15 Jul 2024to 6 Mar 2026
Phase: Early Phase 1
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 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

50-85 years of age
Able to understand and speak English and follow study procedures
Does not have a psychological or neurological condition that would prevent being able to give consent to participate
Not currently involved in any other cognitive or memory training studies

Who cannot join

Formal diagnosis of dementia or other neurological disease, including Mild cognitive impairment.
A final total score below 17 on Montreal Cognitive Assessment - Blind (telephone) version.
Score of 10 or more on the Generalized Anxiety Questionnaire (GAD7; Spitzer et al., 2006, Archives of Internal Medicine), indicating presence of moderate or severe anxiety
Score of 9 or more on Geriatric depression scale (GDS15; Yesavage et al., 1982) indicating presence of moderate or severe depression
Abnormal visual acuity prohibitive of tablet-based training.
Physical handicap (motor or perceptual) that would impede training procedures.

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Medical illness requiring treatment and/or significant absences during the study timeline.
Current evidence or 2-yr history of seizures, focal brain lesion, or head injury with loss of consciousness.
Current alcohol consumption exceeds 14 drinks per week.
Self-reported illicit drug use.

Trial locations and contacts

1 site in 1 country.

United States1 site

Northeastern University
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Feasibility Study of Working Memory Training for People Aging With HIV

The present study investigates the feasibility of working memory training in people aging with HIV (PAWHIV). In a cross-over design this stage 1 feasibility trial, will evaluate acceptability, and estimate possible effect sizes related to working memory training by examining potential differential effects in PAWHIV and those aging without HIV. This project highlights the importance of tailored cognitive assessments and interventions, engaging with underrepresented communities to enhance inclusivity in cognitive health research.

Read the detailed description

In a randomized controlled trial (RCT) with a 3x2 design (pre-test, post-test, follow-up; PAWHIV, people aging without HIV), we will evaluate feasibility of implementing working memory-based interventions in PAWHIV. This study will examine the differential effects of WM training between PAWHIV and aging adults without HIV, providing insight into specific cognitive challenges in PAWHIV that may influence the efficacy of cognitive training interventions. The results of this trial will be instrumental in developing targeted, evidence-based interventions that promote cognitive health for PAWHIV and contribute to the broader understanding of cognitive aging in vulnerable populations.

Relying on an extended battery of cognitive assessments, we will test different multivariate models to best capture the unique cognitive profiles of PAWHIV and how they compare with people aging without HIV. This analytical framework will allow us to gain insight into and better addressing the needs of the PAWHIV community

The cross-over trial will obtain within-subject comparisons of training with enriched (game-like) versions of working memory training tasks compared to basic (non-gamified) versions of these tasks. Participants are assigned to Non-Gamified Span training and Gamified Span training for a total of 50 sessions per participant: the first few sessions consist of completing questionnaires and computerized cognitive assessments (pre-test). Participants then complete 20 sessions of working memory training. After a mid-test, they complete 20 sessions of a different type of working memory training. Post-test is administered upon training completion, and at least a month later, participants complete 3 follow-up sessions.

Conditions: Cognitive Change
Being tested: Span

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SpanBehavioural
The training program is a personal device-based adaptive version of a visual working memory span task, either devoid of game elements or embedded in a gamified platform game

Study groups in NCT06699927
Study group	Role	What they receive
Non-gamified First	Active comparator	Training type 1 will be administered in the first part of the crossover trial and Training type 2 will be administered in the second part of the trial. Each training part consists of 20 twenty-minute long sessions with the recommended frequency of 2 sessions per work day. Thus each training part can be completed in 10 work days (2 weeks). Receives: Behavioral: Span
Gamified First	Active comparator	Training type 2 will be administered in the first part of the crossover trial and Training type 1 will be administered in the second part of the trial. Each training part consists of 20 twenty-minute long sessions with the recommended frequency of 2 sessions per work day. Thus each training part can be completed in 10 work days (2 weeks). Receives: Behavioral: Span

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Everyday Memory Questionnaire Revised
The Everyday Memory Questionnaire Revised (Royle \& Lincoln, 2008) consists of 13 items that describe everyday events that might involve forgetting. Participants are asked how often on average they think each one has happened to them over the past month on a 5-point scale (0-4) and the total score is calculated as the sum of all responses. The minimum total score is 0 and the maximum is 52, with higher scores indicative of greater presence of memory difficulties. The outcome measure is the change in total score at the point of measurement compared to baseline at Day 1.
Measured: Day 24, Day 46, Day 77
Change in General Cognitive Ability Composite Score
A composite score will be generated by taking the average of standardized outcome measures on tasks in the Standard Older Adult Cognitive Battery (SOACB), which consists of word list learning, complex figure copy, object naming, trail making, a vocabulary task, and matrix reasoning. The outcome measure is the change in the composite score reached on the task compared to baseline at Day 1.
Measured: Day 77

Secondary outcomes (6)

Change in Inhibitory Control Composite Score
The score is the mean of standardized dependent variables on tablet-based inhibitory control tasks. The outcome measure is the change in the composite score at the point of measurement compared to baseline at Day 2.
Measured: Day 24, Day 46, Day 78
Training Experience Enjoyment
Scores range from 1 to 5, with higher scores indicative of greater enjoyment of the training task enjoyment, subjective progress, and satisfaction of the training task
Measured: Day 24, Day 46
Training Experience Subjective Progress
Scores range from 1 to 5, with higher scores indicative of greater subjective of the training task progress.
Measured: Day 24, Day 46
Training Experience Satisfaction Scale
Scores range from 1 to 5, with higher scores indicative of greater satisfaction of the training task.
Measured: Day 24, Day 46
Training Experience Difficulty Scale
Scores range from 1 to 10, with scores 1-3 indicating that the training was too easy, scores 4-7 indicating that the training was of appropriate difficulty, and scores 8-10 indicating that it was too difficult.
Measured: Day 24, Day 46
Exit Survey
Participants are asked 5 open-ended questions about their subjective experience of participating in the study.
Measured: Time Frame: Day 79

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 20246 Mar 2026

First posted21 Nov 2024
Study start15 Jul 2024
Primary completion6 Mar 2026
Study completion6 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cognitive ChangeStudies 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: Early Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: A randomized crossover trial will be conducted and participants will be randomly assigned to 1 of 2 conditions: Condition 1 consists of training type 1 followed by training type 2, whereas Condition 2 consists of training type 2 followed by training type 1. They will be assigned to Non-Gamified Span training and Gamified Span training.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06699927
Sponsor's protocol ID: NU-20241107
Status last verified: Apr 2026
First submitted: 19 Nov 2024
Last updated: 20 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Intervention materials and individual participant data (anonymized)

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Study of Working Memory Training for People Aging With HIV
ClinicalTrials.gov ID: NCT06699927
Acronym / sponsor ID: NU-20241107
Conditions: Cognitive Change
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Northeastern UniversityUniversity, hospital or other
Study start: 15 Jul 2024 (actual)
Primary completion: 6 Mar 2026 (actual)
Study completion: 6 Mar 2026 (actual)
First posted: 21 Nov 2024 (actual)
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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: A randomized crossover trial will be conducted and participants will be randomly assigned to 1 of 2 conditions: Condition 1 consists of training type 1 followed by training type 2, whereas Condition 2 consists of training type 2 followed by training type 1. They will be assigned to Non-Gamified Span training and Gamified Span training.

Arm	Type	Receives
Non-gamified First	Active comparator	Behavioral: SpanTraining type 1 will be administered in the first part of the crossover trial and Training type 2 will be administered in the second part of the trial. Each training part consists of 20 twenty-minute long sessions with the recommended frequency of 2 sessions per work day. Thus each training part can be completed in 10 work days (2 weeks).
Gamified First	Active comparator	Behavioral: SpanTraining type 2 will be administered in the first part of the crossover trial and Training type 1 will be administered in the second part of the trial. Each training part consists of 20 twenty-minute long sessions with the recommended frequency of 2 sessions per work day. Thus each training part can be completed in 10 work days (2 weeks).

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

50-85 years of age
Able to understand and speak English and follow study procedures
Does not have a psychological or neurological condition that would prevent being able to give consent to participate
Not currently involved in any other cognitive or memory training studies

Key exclusion criteria (10 listed)

Formal diagnosis of dementia or other neurological disease, including Mild cognitive impairment.
A final total score below 17 on Montreal Cognitive Assessment - Blind (telephone) version.
Score of 10 or more on the Generalized Anxiety Questionnaire (GAD7; Spitzer et al., 2006, Archives of Internal Medicine), indicating presence of moderate or severe anxiety
Score of 9 or more on Geriatric depression scale (GDS15; Yesavage et al., 1982) indicating presence of moderate or severe depression
Abnormal visual acuity prohibitive of tablet-based training.

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
SpanThe training program is a personal device-based adaptive version of a visual working memory span task, either devoid of game elements or embedded in a gamified platform game	Behavioural	Gamified First, Non-gamified First

Primary outcome

Change in Everyday Memory Questionnaire Revised
Time frame: Day 24, Day 46, Day 77
The Everyday Memory Questionnaire Revised (Royle \& Lincoln, 2008) consists of 13 items that describe everyday events that might involve forgetting. Participants are asked how often on average they think each one has happened to them over the past month on a 5-point scale (0-4) and the total score is calculated as the sum of all responses. The minimum total score is 0 and the maximum is 52, with higher scores indicative of greater presence of memory difficulties. The outcome measure is the change in total score at the point of measurement compared to baseline at Day 1.
Change in General Cognitive Ability Composite Score
Time frame: Day 77
A composite score will be generated by taking the average of standardized outcome measures on tasks in the Standard Older Adult Cognitive Battery (SOACB), which consists of word list learning, complex figure copy, object naming, trail making, a vocabulary task, and matrix reasoning. The outcome measure is the change in the composite score reached on the task compared to baseline at Day 1.

6 secondary outcomes

Change in Inhibitory Control Composite Score
Time frame: Day 24, Day 46, Day 78
Training Experience Enjoyment
Time frame: Day 24, Day 46
Training Experience Subjective Progress
Time frame: Day 24, Day 46
Training Experience Satisfaction Scale
Time frame: Day 24, Day 46
Training Experience Difficulty Scale
Time frame: Day 24, Day 46
Exit Survey
Time frame: Time Frame: Day 79

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 20 Apr 2026.
Individual participant dataSharing planned: Yes. Intervention materials and individual participant data (anonymized)

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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.

Susanne Jaeggi, PhD principal investigator

Northeastern University

Aaron Seitz principal investigator

Northeastern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Span in people with Cognitive Change, run by Northeastern University 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 4 inclusion and 10 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 20 Apr 2026. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in Everyday Memory Questionnaire Revised (time frame: Day 24, Day 46, Day 77). The study lists 2 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 NCT06699927.

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 20 Apr 2026.