Memory Training for Cognitive Impairment

Overseen By Audrey Carrillo, MA

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northeastern University

Disqualifiers: Dementia, Neurological disease, Severe anxiety, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 46

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how memory training might assist people living with HIV as they age, compared to those aging without HIV. Participants will engage in two types of memory training: one non-gamified and the other gamified, to determine which is more effective. The study targets individuals with HIV who frequently encounter memory challenges. Those living with HIV and experiencing daily memory problems may be well-suited for this trial. As an Early Phase 1 trial, the study seeks to understand how these memory training methods function in people, providing participants an opportunity to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators.

What prior data suggests that this working memory training is safe for people aging with HIV?

Research has shown that cognitive training, like the one in this study, is generally safe. In past studies, computerized cognitive training improved memory and attention without causing serious side effects. For example, one study found that a six-week cognitive training program helped prevent memory problems caused by stress, again without major negative effects.

Additionally, a review of several studies found that this type of training can improve memory in people with mild cognitive impairment (MCI) or dementia, suggesting it is well-tolerated by different groups. These findings provide some reassurance about the safety of the treatments being tested in this trial. However, since this trial is in an early stage, specific safety data for this particular treatment may not yet be available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Memory Training for Cognitive Impairment trial because it explores new approaches to enhancing cognitive function. Unlike traditional methods that often rely on medication, this trial investigates the effectiveness of two different memory training techniques. One is non-gamified, focusing purely on structured memory exercises, while the other is gamified, incorporating game-like elements to potentially make the training more engaging. These distinct approaches could offer alternative strategies for improving cognitive abilities, providing options that are interactive and can be completed in a short time frame of just two weeks.

What evidence suggests that this working memory training is effective for cognitive impairment in people aging with HIV?

This trial will compare two types of memory training exercises: a non-gamified version and a gamified version. Research has shown that the brain exercises used in this study can help improve memory. Studies have found that exercises focusing on working memory and mental control effectively enhance memory skills. One study reported improvements in verbal, visual, and working memory after using computer-based brain exercises, with noticeable gains in each area. Another study found that working memory exercises can help older adults with mild memory problems. Overall, these findings suggest that the memory training under study could benefit people aging with HIV. ^{1 3 6 7 8}

Who Is on the Research Team?

Susanne Jaeggi, PhD

Principal Investigator

Northeastern University

Aaron Seitz

Principal Investigator

Northeastern University

Are You a Good Fit for This Trial?

This trial is for individuals aging with HIV who may be experiencing cognitive impairments. It aims to include a diverse group of participants to ensure inclusivity in the research.

Inclusion Criteria

Not currently involved in any other cognitive or memory training studies

Does not have a psychological or neurological condition that would prevent being able to give consent to participate

I am between 50 and 85 years old.

Exclusion Criteria

Score of 9 or more on Geriatric depression scale (GDS15; Yesavage et al., 1982) indicating presence of moderate or severe depression

Current alcohol consumption exceeds 14 drinks per week

I have had seizures, a brain injury, or lost consciousness due to a head injury in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-test

Participants complete questionnaires and computerized cognitive assessments

1 week

1 visit (in-person)

Training Phase 1

Participants complete 20 sessions of working memory training (either gamified or non-gamified)

2 weeks

20 sessions (virtual)

Mid-test

Participants undergo mid-test assessments

1 week

1 visit (in-person)

Training Phase 2

Participants complete another 20 sessions of working memory training with the alternate method

2 weeks

20 sessions (virtual)

Post-test

Post-test assessments are administered upon training completion

1 week

1 visit (in-person)

Follow-up

Participants complete 3 follow-up sessions to monitor long-term effects

4 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Span

Trial Overview

The study is testing 'Span', a working memory training program, to see if it's feasible and acceptable for people aging with HIV and how effective it might be compared to those without HIV.

How Is the Trial Designed?

Group I: Non-gamified First Active Control 1 Intervention

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).

Group II: Gamified First Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

Northeastern University

Lead Sponsor

Trials

103

Recruited

72,600+

Published Research Related to This Trial

The RehaCom computerized cognitive training program significantly improved attention and memory functions in 50 brain injury patients after 60 training sessions, with all patients showing enhanced performance in the targeted areas.

The program was well-tolerated, with no reported negative effects such as mental fatigue, headache, or eye irritation, indicating its safety for use in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. Fernández, E., Bringas, ML., Salazar, S., et al.[2022]

Working memory training programs can lead to improvements in cognitive functions for older adults, including those with mild cognitive impairments and dementia, suggesting that these programs may help maintain autonomy in daily activities.

The benefits of working memory training are supported by changes in brain activity, indicating that such training enhances the efficiency of neural processes related to working memory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working memory training in normal and pathological ageing: neurocognitive gains and their impact on daily-living activities. Saba, M., Blanchet, S.[2021]

Memory training significantly improved memory performance in older adults over a 5-year period, as shown in a study involving 629 participants from the ACTIVE trial.

Factors such as higher education and better self-rated health were linked to greater improvements in memory performance, while booster training and adherence did not enhance the benefits of the initial training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory training in the ACTIVE study: how much is needed and who benefits? Rebok, GW., Langbaum, JB., Jones, RN., et al.[2021]

A novel cognitive training program called multi-strategic metamemory training significantly improved long-term delayed free recall and fluency in 66 older adults with mild cognitive impairment compared to a control group of 47 participants.

Participants in the training group also reported a significant decrease in subjective memory complaints, indicating that the program not only enhanced cognitive performance but also improved their perception of everyday memory function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Improvement in Older Adults with Mild Cognitive Impairment: Evidence from a Multi-Strategic Metamemory Training. Youn, JH., Park, S., Lee, JY., et al.[2020]

The study involved 66 older adults with mild cognitive impairment (MCI) who participated in a virtual interactive working memory training (VIMT) program, showing a significant improvement in working memory compared to an active control group after 36 training sessions.

The VIMT program not only helped maintain working memory but also potentially reduced cognitive decline in older adults with MCI, indicating its efficacy as an intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial. Yang, HL., Chu, H., Kao, CC., et al.[2020]

The WOME (WOrking MEmory) training program significantly improved working memory function in 60 healthy older adults, with moderate to large effect sizes observed immediately after the intervention.

However, the benefits were short-lived, as improvements diminished significantly by the 3-month follow-up, indicating that while WOME is effective in the short term, it may not lead to lasting changes in working memory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WOME: Theory-Based Working Memory Training - A Placebo-Controlled, Double-Blind Evaluation in Older Adults. Weicker, J., Hudl, N., Frisch, S., et al.[2020]

Cognitive training significantly improves memory in older adults with amnestic mild cognitive impairment (MCI), with benefits lasting for at least 6 months after the training.

Participants who underwent cognitive training not only showed improved memory scores but also effectively applied learned strategies in their daily lives, unlike those in psychosocial or control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MEMO+: Efficacy, Durability and Effect of Cognitive Training and Psychosocial Intervention in Individuals with Mild Cognitive Impairment. Belleville, S., Hudon, C., Bier, N., et al.[2022]

In a study of 65 participants with moderate to severe traumatic brain injury (TBI), those with higher working memory capacity (WMC) showed significantly greater improvement in memory rehabilitation outcomes compared to those with lower WMC.

Working memory capacity can serve as a valuable cognitive marker to predict who will benefit from memory rehabilitation strategies, accounting for 45% of the variance in treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual Differences in Working Memory Capacity Predicts Responsiveness to Memory Rehabilitation After Traumatic Brain Injury. Sandry, J., Chiou, KS., DeLuca, J., et al.[2018]

A holistic cognitive training program involving 112 older adults showed significant improvements in attention and working memory across various cognitive measures after 7 sessions.

Participants with lower risk status (Low and Medium) demonstrated greater cognitive gains compared to those in the High Risk Group, suggesting that the effectiveness of the training may vary based on the severity of memory complaints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory intervention: the value of a clinical holistic program for older adults with memory impairments. Hyer, L., Scott, C., Lyles, J., et al.[2018]

A 5-week online working memory training program for older adults (ages 64-79) led to significant improvements in auditory short-term memory, which were maintained for 6 months after training.

The training also showed a positive transfer effect to long-term episodic memory, although there was no direct improvement in overall working memory capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of a working memory training scheme in older adults. McAvinue, LP., Golemme, M., Castorina, M., et al.[2022]

The Memory Support System (MSS) was successfully learned and utilized by 20 participants with amnestic mild cognitive impairment (MCI), with 95% compliance at the end of training and 89% at follow-up.

Participants showed a medium effect size in improved functional ability, along with reported benefits in independence, self-confidence, and mood, indicating that the MSS may effectively help manage memory loss symptoms in MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A behavioral rehabilitation intervention for amnestic mild cognitive impairment. Greenaway, MC., Hanna, SM., Lepore, SW., et al.[2022]

A cognitive intervention for 52 older adults with amnestic mild cognitive impairment led to significant improvements in everyday memory performance, particularly in prospective memory tasks, after just 2 weeks.

Participants also showed increased knowledge and use of memory strategies following the intervention, suggesting that early cognitive rehabilitation can help manage memory difficulties effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early intervention for mild cognitive impairment: a randomised controlled trial. Kinsella, GJ., Mullaly, E., Rand, E., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

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Cogmed cognitive training for working memory

This systematic review aimed to evaluate the effectiveness of Cogmed Working Memory Training (CWMT), a commercial program designed to improve WM.

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Computerized cognitive training for memory functions in ...

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Conclusions: The present study supported that cognitive training could effectively improve working memory in elders with MCI. The training effects on working ...

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It has been suggested that working memory training programs are effective both as treatments for attention-deficit/hyperactivity disorder ...

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For the first time, our results demonstrated that a 6-week cognitive training intervention can prevent this stress-induced working memory impairment. ...

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clinicaltrials.gov/ct2/show/NCT05380739?draw=2&rank=1

NCT05380739 | Memory Training and Neural Plasticity

This study will evaluate the efficacy of working memory training in older adults with amnestic mild cognitive impairment (MCI). Detailed Description. Working ...

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Utilizing Cognitive Training to Improve Working Memory, ...

The use of computerized cognitive training has demonstrated improved attention and working memory skills in children with WM deficits.