Cognitive Training for Older Adults' Cognitive Health

Overseen By Hanzhang Xu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Bed-ridden, chemotherapy, life-threatening illnesses

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile health (mHealth) program designed to help older Chinese Americans maintain cognitive sharpness. The program includes cognitive training exercises, known as Cognitive Training Intervention, delivered via smartphone or tablet. It aims to enhance mental functions and potentially prevent cognitive decline. Participants will engage in these activities several times a week for 12 weeks. The trial seeks Chinese individuals aged 60 or older who can read and understand either Chinese or English and have no known cognitive impairments. As an unphased trial, this study offers a unique opportunity to contribute to research that could benefit the community's mental health.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this cognitive training intervention is safe for older adults?

Research shows that cognitive training is generally safe for older adults. Studies have found that this training can enhance memory and thinking skills, with few negative effects reported. For example, one study found that combining movement with thinking tasks significantly improved memory and decision-making skills without major side effects.

Another study showed that methods like reminiscence therapy, which involves recalling past experiences, effectively boost overall brain health. These activities are simple and well-tolerated, with participants rarely reporting negative effects, making them a safe option for many.

Overall, cognitive training programs like the one tested in this trial are considered safe and helpful for maintaining and improving brain health in older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this cognitive training intervention because it uses a unique, tech-based approach to enhance cognitive health in older adults. Unlike traditional treatments for cognitive decline, which typically involve medications or physical therapies, this method leverages smartphone or tablet-based exercises designed to stimulate the brain. This approach is not only accessible and engaging but also empowers individuals to participate actively in their cognitive health management. The hope is that these exercises will provide a practical, non-invasive way to maintain and even improve cognitive functions, offering a new avenue of support for aging populations.

What evidence suggests that this cognitive training intervention is effective for cognitive health?

Research has shown that brain exercises can improve thinking and memory in older adults. One study found that these exercises enhance overall brain function and specific mental tasks. Another study demonstrated that both simple and complex brain exercises effectively keep the mind sharp in healthy older adults. These exercises function like physical exercise for the brain, helping to maintain its strength. In this trial, participants in the Cognitive Training arm will engage in a series of cognitive training exercises on a smartphone or tablet, which may provide similar benefits. Although specific data for Chinese Americans is limited, general evidence suggests that brain exercises benefit mental health as people age. ^{1 6 7 8 9}

Who Is on the Research Team?

Hanzhang Xu, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for older Chinese Americans, aged 60 or above, who can see and hear well enough to use a smartphone or tablet. They should be fluent in Chinese and/or English, self-identify as Chinese, have no reported cognitive impairments or Alzheimer's disease-related dementias (ADRD), and must be able to consent. Those bed-ridden, undergoing chemotherapy for cancer, or with other life-threatening illnesses cannot participate.

Inclusion Criteria

Self-identify as Chinese

I am 60 years old or older.

I do not have any cognitive impairments and can make decisions for myself.

Exclusion Criteria

I am not confined to bed.

I am currently undergoing chemotherapy for cancer.

I do not have any other life-threatening illnesses.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a series of cognitive training exercises on a smartphone/tablet for 12 weeks, involving 3-4 sessions per week

12 weeks

Sessions conducted remotely via app

Follow-up

Participants are monitored for changes in cognition, loneliness, anxiety, depressive symptoms, quality of life, and physical functioning

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Training Intervention

Trial Overview

The study aims to develop and test a mobile health (mHealth) app designed specifically for cognitive training that suits the cultural and linguistic needs of older Chinese Americans. The intervention involves using this app regularly over the course of the study.

How Is the Trial Designed?

Group I: Cognitive Training Experimental Treatment 1 Intervention

Participants in the experimental arm will be provided a brochure that included information on basic knowledge of ADRD, signs and symptoms related to ADRD, the definition and the potential benefits of cognitively stimulating activities in maintaining cognitive function, and examples of cognitively stimulating activities. Participants in this arm will complete a series of cognitive training exercises on a smartphone/tablet. The anticipated training will last for 12 weeks and involve 3-4 sessions per week (20-30 min/ session).

Group II: Passive Control Active Control 1 Intervention

A passive control group will be included in this pilot trial. Participants in this passive control arm will be provided a brochure that included information on basic knowledge of ADRD, signs and symptoms related to ADRD, the definition and the potential benefits of cognitively stimulating activities in maintaining cognitive function, and examples of cognitively stimulating activities.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

New York University

Collaborator

Trials

249

Recruited

229,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

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]

The SmartTapestry device, tested on 53 participants (29 healthy and 24 with mild cognitive impairment), effectively combines physical activity with cognitive training, showing a strong correlation with traditional cognitive tasks.

This innovative approach suggests that cognitive-physical training tools can enhance cognitive function while being used at home, potentially improving treatment efficacy for cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can physical and cognitive training based on episodic memory be combined in a new protocol for daily training? Maselli, M., Fiorini, L., Cecchi, F., et al.[2020]

Cognitive training has been shown to significantly improve subjective cognitive function and certain objective cognitive skills, such as working memory and episodic memory, in breast cancer patients experiencing cognitive changes, based on a systematic review of 9 randomized controlled trials involving 666 patients.

Despite these improvements, cognitive training did not lead to significant changes in attention, short-term memory, executive function, or psychological outcomes like anxiety and depression, indicating that while cognitive training can be beneficial, it may not address all cognitive and emotional challenges faced by these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cognitive training on patients with breast cancer reporting cognitive changes: a systematic review and meta-analysis. Yan, X., Wei, S., Liu, Q.[2023]

Cognitive rehabilitation interventions are effective treatments for individuals with traumatic brain injury (TBI), helping to improve cognitive functions, emotional well-being, and overall daily functioning.

These interventions not only enhance awareness of injury-related deficits but also promote community involvement and reduce the risk of secondary disabilities, highlighting their comprehensive role in recovery after TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role and impact of cognitive rehabilitation. Dams-O'Connor, K., Gordon, WA.[2022]

Cognitive rehabilitation is a structured intervention that helps individuals recover cognitive skills after a brain injury, using tailored treatment plans based on thorough neuropsychological assessments.

It has been shown to be effective for a range of cognitive impairments, from mild to severe injuries, and can lead to significant improvements in cognitive abilities and overall psychosocial functioning at any time after the injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation following traumatic brain injury: assessment to treatment. Tsaousides, T., Gordon, WA.[2009]

Cognitive training intervention (CTI) significantly improved global cognitive function in healthy elderly participants after 12 weeks, with a mean difference score of 0.57 compared to a wait-list group, indicating its efficacy.

However, there was no lasting carry-over effect observed at 24 weeks, suggesting that while CTI can provide short-term benefits, its effects may not be sustained over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Cognitive Training in Healthy Community Residing Thai Elderly: A Randomized Controlled Trial. Phanasathit, M., Nimnuan, C., Lohsoonthorn, V.[2023]

In a study of 241 older adults in rehabilitation, all participants showed significant functional improvement in daily living activities, regardless of their cognitive status, indicating that rehabilitation can be beneficial for everyone.

However, those with lower cognitive scores experienced longer hospital stays and had higher rates of institutionalization and mortality, highlighting the need for tailored care in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does cognitive impairment affect rehabilitation outcome? Poynter, L., Kwan, J., Sayer, AA., et al.[2021]

Cognitive training using serious games showed positive interactions and outcomes for patients with cognitive impairment in a pilot study involving 14 participants, indicating potential benefits for cognition and mood.

However, participant retention was a challenge, with only half continuing after five weeks due to factors like patient turnover and difficulties in integrating the training into daily routines, highlighting the importance of facilitator support and individualized program adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[User friendliness of computer-based cognitive training for psychogeriatric patients with mild to moderate cognitive impairments]. van der Ploeg, ES., Hoorweg, A., van der Lee, J.[2016]

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