Lifestyle Interventions for Early Onset Alzheimer's Disease

(LITES Trial)

Overseen By Dustin B Hammers, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Internet access less than 4 hours

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

Compensation: Varies

Number of Visits: 2

Duration: 14 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether certain activities can help individuals with Early-Onset Alzheimer's Disease. Participants will engage in either cognitive training (also known as computerized cognitive training or cognitive therapy) and Tai Chi-Qi Gong exercises, or play brain games and perform stretching (also referred to as flexibility exercises or physical therapy) for 14 weeks. The researchers aim to determine if these activities improve thinking skills, daily functioning, and mood more effectively than the alternatives. Suitable candidates have already been diagnosed with Early-Onset Alzheimer's, are fluent in English, and have a friend or family member who knows them well. As an unphased trial, this study offers a unique opportunity to contribute to understanding how lifestyle activities can impact Alzheimer's, potentially benefiting future patients.

Do I need to stop my current medications for this trial?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown promising results for both computerized brain training and Tai Chi-Qi Gong exercises. Research suggests that structured computerized brain training can enhance thinking skills and daily activities in people with early Alzheimer's disease. Participants generally find these activities manageable, with no major safety concerns reported in previous studies.

Similarly, Tai Chi-Qi Gong has demonstrated potential benefits for both mental and physical health in older adults. Evidence indicates that these exercises can improve thinking skills and might even slow memory loss. Like brain training, Tai Chi-Qi Gong is usually safe, with studies highlighting its positive effects rather than any negative ones.

Overall, existing research considers both treatments safe and well-tolerated. Participants in studies using these methods have generally not reported serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for early onset Alzheimer's because they offer a holistic and non-pharmacological approach. Unlike typical treatments that rely on medications to manage symptoms, these treatments focus on physical and mental exercises. Tai Chi- Qi Gong and Cognitive Training aim to improve cognitive function and overall well-being through movement and brain exercises, which could provide a natural way to slow disease progression. This approach might offer a safer alternative with fewer side effects compared to traditional drug therapies.

What evidence suggests that this trial's treatments could be effective for Early-Onset Alzheimer's Disease?

Research shows that computer programs for brain training can improve memory and thinking skills. One study found significant boosts in various types of memory, such as remembering words, images, and temporarily needed information. Another study found that this training can delay the onset of mild cognitive impairment (MCI) and dementia, early stages of Alzheimer's disease. In this trial, participants in the Experimental Cognitive Training and Tai Chi-Qi Gong Arm will receive Cognitive Training.

Research also suggests that Tai Chi and Qi Gong benefit both body and mind. One analysis found these exercises improved physical and mental abilities in older adults. Another study showed that Tai Chi can slow mental decline in elderly individuals with emerging memory problems. Participants in the same arm will also receive Tai Chi-Qi Gong exercise training.

Meanwhile, the Active Control Arm will receive Brain Games and stretching exercises. Overall, combining brain training with Tai Chi and Qi Gong appears promising for improving mental health in individuals with early-onset Alzheimer's. ^{1 6 7 8 9}

Who Is on the Research Team?

Dustin B Hammers, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for people aged 40-64 with Early-Onset Alzheimer's Disease, who are in good health without other neurological disorders. Participants must be fluent in English, have an informant, and be able to see, hear, understand and perform tasks well enough to engage in the study activities.

Inclusion Criteria

Have had a Clinical Dementia Rating scale of 0.5 to 1.0 at the time of enrollment into LEADS

Fluent in English

I am part of the LEADS study and have early-onset Alzheimer's confirmed by tests.

Exclusion Criteria

Have access to the internet (e.g., home, family, public library, etc.) for less than 4 hours per week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete cognitive, functional, and mood assessments at a remotely-assessed baseline visit

1 week

1 visit (virtual)

Treatment

Participants receive 14 weeks of Cognitive Training and Tai Chi- Qi Gong exercise or Brain Games and stretching

14 weeks

Post-Treatment Assessment

Outcome measures are repeated immediately post-treatment

1 week

1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brain Games
• Cognitive Training
• Stretching
• Tai Chi- Qi Gong

Trial Overview The study is testing if brain games and Tai Chi-Qi Gong can improve cognition, functioning, and mood in those with Early-Onset Alzheimer's. It compares computerized cognitive training (experimental) against stretching exercises (control) to see which is more effective.

How Is the Trial Designed?

Group I: Experimental Cognitive Training and Tai Chi- Qi Gong Arm Experimental Treatment 2 Interventions

Participants receiving 14 weeks of Cognitive Training (BrainHQ) and Tai Chi- Qi Gong exercise training

Group II: Active Control Arm Active Control 2 Interventions

Participants receiving 14 weeks of Brain Games (BrainHQ) and stretching

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Alzheimer's Therapeutic Research Institute

Collaborator

Trials

18

Recruited

58,400+

Tai Chi Foundation

Collaborator

Trials

1

Recruited

60+

Alzheimer's Association

Collaborator

Trials

103

Recruited

44,300+

Published Research Related to This Trial

A 1-year qigong exercise program significantly reduced the risk of cognitive decline in older Chinese adults compared to a stretching exercise, with a notable odds ratio of 0.314 indicating lower progression of cognitive impairment.

Participants in the qigong group showed significantly higher scores in global cognition and various cognitive domains (memory, visuospatial ability, and language) compared to the stretching group, highlighting the effectiveness of qigong in improving cognitive functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 1 Year of Qigong Exercise on Cognitive Function Among Older Chinese Adults at Risk of Cognitive Decline: A Cluster Randomized Controlled Trial. Jin, J., Wu, Y., Li, S., et al.[2020]

Lifestyle interventions, such as education, social engagement, and exercise, can significantly reduce the risk of developing Alzheimer's disease (AD), as shown in a systematic review of various studies.

The review highlights that combining multiple lifestyle changes can be effective in delaying or preventing AD, addressing the need for alternative approaches given the limited treatment options available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle intervention to prevent Alzheimer's disease. Ko, Y., Chye, SM.[2020]

This systematic review will evaluate the effectiveness and safety of Tai Chi (TC) for individuals with mild cognitive impairment (MCI) by analyzing randomized controlled trials from various databases, covering studies published from January 1990 to March 2019.

The review aims to provide updated evidence on whether TC can improve cognitive function in MCI patients compared to placebo, conventional treatments, or no treatment, potentially highlighting TC as a beneficial intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tai Chi for patients with mild cognitive impairment: A protocol for a systematic review and meta-analysis of randomized controlled trials. Yang, J., Chon, TY., Li, G., et al.[2023]

In a 1-year study involving 389 Chinese elders at risk of cognitive decline, those practicing Tai Chi showed a significantly lower risk of developing dementia compared to those doing stretching and toning exercises, with an odds ratio of 0.21.

Participants in the Tai Chi group also demonstrated better preservation of cognitive function and mood, with notable improvements in memory recall and reduced depressive symptoms, indicating the potential benefits of mind-body exercises for cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 1-year randomized controlled trial comparing mind body exercise (Tai Chi) with stretching and toning exercise on cognitive function in older Chinese adults at risk of cognitive decline. Lam, LC., Chau, RC., Wong, BM., et al.[2022]

Mind-body exercises (MBE) like tai chi, yoga, and qigong significantly improve cognitive functions such as attention, short-term memory, executive function, and global cognitive function in individuals with mild cognitive impairment (MCI), based on a meta-analysis of 12 studies involving 1298 participants.

While MBE showed positive effects on various cognitive areas, it did not significantly enhance cognitive processing speed, indicating that while beneficial, the impact of MBE may vary across different cognitive domains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Beneficial Effects of Mind-Body Exercises for People With Mild Cognitive Impairment: a Systematic Review With Meta-analysis. Zou, L., Loprinzi, PD., Yeung, AS., et al.[2021]

A home-based multimodal exercise program for 40 older adults with mild to moderate Alzheimer's disease is expected to improve muscle strength, balance, cognition, and overall functioning after 16 weeks of training.

The study aims to provide a foundation for future clinical interventions and health promotion strategies tailored for older individuals with Alzheimer's, highlighting the potential benefits of at-home exercise for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based multimodal exercise program in older people with Alzheimer disease: Randomized controlled trial protocol. Cezar, NOC., Ansai, JH., de Andrade, LP.[2021]

The prevalence of Tai Chi and Qigong (TCQ) use among U.S. adults increased significantly from 1.17% in 2007 to 1.70% in 2017, indicating a growing interest in these mind-body practices over the decade.

The increase in TCQ use was particularly notable among older adults, low-income individuals, and those who were physically inactive, suggesting that TCQ may be a beneficial and accessible form of exercise for these populations to address health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends and characteristics of Tai Chi and Qi Gong use among U.S. adults: Results from the 2007-2017 National Health Interview Survey. Wang, CC., Li, K., Gaylord A, S.[2022]

A study involving 48 individuals with amnestic mild cognitive impairment found that both a combined intervention of Taoist Tai Chi (TTC) and a memory intervention program (MIP) and MIP alone improved memory strategy knowledge and everyday memory behaviors.

However, the addition of TTC did not provide any additional benefits for cognition, gait, or balance, suggesting that while both interventions were effective, TTC did not enhance the outcomes beyond those achieved with MIP alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taoist Tai Chi® and Memory Intervention for Individuals with Mild Cognitive Impairment. Fogarty, JN., Murphy, KJ., McFarlane, B., et al.[2017]

A 12-week Tai Chi program for older adults with mild cognitive impairment (MCI) or dementia was found to be feasible and well-accepted, with an impressive attendance rate of 87% and no reported adverse events.

Participants with MCI showed significant improvements in grip strength and health-related quality of life, while both MCI and dementia groups improved their mobility as measured by the Timed Up and Go (TUG) test, indicating that Tai Chi can enhance physical functioning in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 12-week Tai Chi program on physical function, depression, and quality of life among cognitively impaired older adults: a feasibility study. Oh, H., Song, R., Kim, SJ.[2023]

Tai Chi, a mind-body exercise, has been shown to improve cognitive functions and reduce symptoms of mild cognitive impairment (MCI) in older adults, suggesting it could be an effective management strategy for this condition.

The potential benefits of Tai Chi may arise from its ability to activate brain signals, enhance connectivity, increase brain volume, and modulate factors related to brain health, indicating a multifaceted mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitigating effects and mechanisms of Tai Chi on mild cognitive impairment in the elderly. Wang, X., Si, K., Gu, W., et al.[2023]

A randomized controlled trial will assess the effects of 'Cognition Protecting Tai Chi' (CPT) on cognitive function and daily living activities in 80 older adults with mild dementia over 10 months, with participants practicing CPT three times a week under professional guidance.

The primary outcome measure will be the delayed recall score from the WHO-UCLA-Auditory Verbal Learning Test, aiming to evaluate the efficacy of CPT in improving cognitive abilities and reducing fall risks in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of practising Tai Chi for older people with mild dementia: protocol for a randomised controlled study. Lyu, J., Li, W., Rong, X., et al.[2019]

Citations

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Advancing Computerized Cognitive Training for MCI and ... A meta-analysis of 18 studies of CCT for MCI (N = 690) found small to moderate improvements in global cognition, memory and working memory (20).

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Computerized cognitive training for memory functions in ... Supervised CCT showed improvements in verbal memory (0.72 (0.45–0.98)), visual memory (0.51 (0.22–0.79)), and working memory (0.33 (0.01–0.66)).

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An integrated intervention of computerized cognitive ... Computerized structured cognitive training in patients affected by early-stage Alzheimer's disease is feasible and effective: a randomized controlled study.