Cognitive Training for Cognitive Impairment

Overseen By Feng Lin, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Stanford University

Disqualifiers: Major depression, Cardiovascular diseases, Neurological conditions, others

Compensation: Varies

Number of Visits: 7

Duration: 7 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new computer-based program designed to assist people with mild memory problems. Participants will engage with a personalized training game that adjusts based on their heart rate and performance, ensuring an appropriate level of challenge. There are two groups: one will try the new program, called MLA and pSOPT, while the other will engage in regular mental activities. Individuals who frequently forget things and have some difficulty with daily tasks might be suitable, provided their medication doses have remained stable for the past three months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative approach.

Will I have to stop taking my current medications?

The trial requires that if you are on certain medications like Alzheimer's drugs, antidepressants, or medications for vascular risk, your dose should be stable for 3 months before joining. You don't need to stop taking them, but the dosage should not change during this period.

What prior data suggests that this cognitive training program is safe for participants?

Research shows that digital cognitive training, such as pSOPT, is generally safe and effective. Previous studies have found that this training can improve thinking skills without major side effects. These digital methods don't involve drugs, which usually means fewer risks.

This Phase 1 study aims to assess how well participants handle the personalized pSOPT program. Phase 1 trials are the first step in testing new treatments in humans, focusing mainly on safety. While evidence is still being collected, past research on cognitive training has been promising, demonstrating safety and effectiveness with minimal risk.

The study also involves MLA, used for comparison and acting as a placebo (an inactive treatment). Therefore, no side effects are expected from this group. Overall, the data so far suggest that participating in this type of cognitive training study is low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cognitive training techniques, pSOPT and MLA, because they offer new ways to address cognitive impairment. Unlike most treatments that rely on medication, pSOPT involves personalized cognitive training combined with monitoring of the parasympathetic nervous system. This innovative approach could lead to more tailored and potentially more effective interventions. Meanwhile, MLA uses computerized mental leisure activities, which might provide a more accessible and engaging form of cognitive stimulation compared to traditional methods. These approaches could open up new avenues for enhancing cognitive function without the side effects associated with medication.

What evidence suggests that this trial's treatments could be effective for cognitive impairment?

Research has shown that computerized brain training can significantly enhance thinking skills, focus, and decision-making in individuals with memory problems. Studies have found that this training can also improve their quality of life. In this trial, participants may receive the personalized brain training program, pSOPT, which adjusts task difficulty using feedback from the body, such as heart rate, to enhance effectiveness for each person. By targeting the part of the nervous system that aids relaxation, it might also offer additional benefits, potentially slowing the progression of serious memory issues like dementia. These findings suggest that pSOPT could effectively support brain health. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people over 60 with mild cognitive impairment, who can read and understand English, have adequate vision and hearing, and are living independently. They should not be severely depressed or have major neurological conditions like Alzheimer's or Parkinson's. Participants must not be in another cognitive study or have serious heart issues.

Inclusion Criteria

I live at home or in a place where I can take care of myself.

My memory test score is below the normal range for my age.

I am 60 years old or older.

Exclusion Criteria

3T MRI contraindication

Currently pregnant

Current enrollment in another cognitive improvement study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo personalized cognitive training with biofeedback and ECG monitoring

7 weeks

Weekly sessions

Follow-up

Participants are monitored for cognitive and autonomic network changes post-treatment

3 months

Assessments at baseline, Week 7, and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• MLA
• pSOPT

Trial Overview The study tests a personalized computer-based cognitive training program that adjusts task difficulty based on the participant's biofeedback (heart rate) and performance. Participants will be randomly assigned to one of two game versions while their ECG is monitored to keep the group they're in secret.

How Is the Trial Designed?

Group I: pSOPT Experimental Treatment 1 Intervention

personalized cognitive training with a close-loop parasympathetic nervous system monitored component

Group II: MLA Placebo Group 1 Intervention

computerized mental leisure activities

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

The study involved two participants with early onset vascular dementia, and after 20 sessions of mixed cognitive intervention training, both showed significant improvements in activities of daily living and cognitive function.

One participant experienced a clinically significant reduction in depression, indicating that spaced retrieval training and errorless learning can effectively enhance cognitive abilities and emotional well-being in early onset dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Mixed Cognitive Intervention Training on Early Onset Dementia. Jeon, BR., Kim, DJ.[2023]

In a pilot study involving 39 participants with mild cognitive impairment (MCI), those who underwent memory training showed significant improvements in both objective and subjective memory outcomes over a 24-month period compared to those who received health training.

The results suggest that the Senior WISE Memory training can effectively slow cognitive decline in individuals with MCI, maintaining benefits in memory function for up to two years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory training for adults with probable mild cognitive impairment: a pilot study. McDougall, GJ., McDonough, IM., LaRocca, M.[2021]

A home-based cognitive training program significantly improved cognitive performance in processing speed and working memory among 68 cognitively normal older adults after 10 weeks of training, compared to an active control group.

The study suggests that even a limited amount of cognitive training (35 hours total) can help maintain cognitive health in older adults, highlighting its potential as a beneficial intervention for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based, Adaptive Cognitive Training for Cognitively Normal Older adults: Initial Efficacy Trial. Lee, HK., Kent, JD., Wendel, C., et al.[2021]

Injections of beta-amyloid25-35 in adult Wistar rats led to long-term memory deficits, which were effectively prevented by administering noopept for 7 days prior to the injury, indicating its potential as a protective agent against cognitive decline.

Noopept also showed significant therapeutic effects when treatment began 15 days post-injury, suggesting it can help restore cognitive function even after neurodegenerative changes have begun, making it a promising candidate for further research in Alzheimer's treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noopept efficiency in experimental Alzheimer disease (cognitive deficiency caused by beta-amyloid25-35 injection into Meynert basal nuclei of rats). Ostrovskaya, RU., Belnik, AP., Storozheva, ZI.[2019]

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]

A study involving 40 participants with early-stage Alzheimer's disease found that a 12-week paper-based cognitive training program significantly improved overall cognitive function, as measured by the Mini-Mental State Examination.

The intervention group showed notable enhancements in specific cognitive areas, including language, attention, and executive function, compared to the control group, suggesting that structured cognitive training can be beneficial for individuals in the early stages of Alzheimer's.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Paper-Based Cognitive Training in Early Stage of Alzheimer's Dementia. Kang, MJ., Kim, SM., Han, SE., et al.[2022]

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]

Noopept, a new nootropic drug, is significantly more effective than pyracetam, requiring 1000 times lower doses and positively influencing memory consolidation and retrieval, unlike pyracetam which only aids early memory stages.

Noopept also exhibits neuroprotective effects and selective anxiolytic action, with mechanisms including antioxidant and anti-inflammatory properties, and it is effective in both parenteral and oral forms, making it suitable for clinical use in treating cognitive deficiencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The original novel nootropic and neuroprotective agent noopept]. Ostrovskaia, RU., Gudasheva, TA., Voronina, TA., et al.[2017]

A new memory training program was developed to improve cognitive functions in individuals with dementia, focusing on generalizing skills to daily activities over 12 lessons in 6 weeks.

Participants in the experimental group showed significant improvements in attention and memory performance compared to the control group, indicating the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of daily living-related cognitive training on attention and memory performance of persons with dementia]. Bernhardt, T., Maurer, K., Frölich, L.[2019]

In an 11-week study involving 181 patients with mild to moderate Alzheimer's disease, the alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid modulator LY451395 did not show significant improvement in cognitive function compared to placebo, as measured by the ADAS-Cog scale.

While there were some marginal improvements in neuropsychiatric symptoms after 8 weeks of treatment, the overall safety profile was similar between LY451395 and placebo, with most adverse events being mild.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AMPA potentiator treatment of cognitive deficits in Alzheimer disease. Chappell, AS., Gonzales, C., Williams, J., et al.[2022]

In a double-blind placebo-controlled study involving healthy elderly volunteers (aged 50 and above), R 58 735 improved memory functions, specifically enhancing the learning and recall of nonsense syllables compared to placebo.

The treatment also reduced proactive inhibition, suggesting that R 58 735 positively affects the encoding and consolidation of new information in older adults, although it did not significantly change short-term memory or retrieval accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of R 58 735 (Sabeluzole) on memory functions in healthy elderly volunteers. Clincke, GH., Tritsmans, L., Idzikowski, C., et al.[2019]

The MEMO+ study is a randomized controlled trial involving 162 participants with mild cognitive impairment (MCI) to evaluate the efficacy of cognitive training and psychosocial interventions over an eight-week period.

The study aims to measure both immediate and long-term effects on cognitive function and daily living skills, potentially leading to improved well-being for individuals with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the impact of cognitive and psychosocial interventions in persons with mild cognitive impairment with a randomized single-blind controlled trial: rationale and design of the MEMO+ study. Bier, N., Grenier, S., Brodeur, C., et al.[2022]

CogSMART and CCT are effective cognitive training interventions for individuals with traumatic brain injury or neuropsychiatric disorders, showing broad use in real-world settings with high patient satisfaction and attendance rates.

The adaptability of CogSMART/CCT, along with easy access to training manuals, has facilitated its implementation by various healthcare providers, suggesting potential for wider adoption beyond specialized neuropsychologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-method study of the implementation of Cognitive Symptom Management and Rehabilitation Training (CogSMART) in real-world settings. Lindamer, L., Almklov, E., Pittman, JOE., et al.[2022]

In a 6-month study involving male and female rabbits, noopept was found to be safe at doses of 10 or 100 mg/kg, showing no irreversible damage to organs or systems and no signs of allergenic, immunotoxic, or mutagenic effects.

Noopept demonstrated a dose-dependent ability to suppress inflammation and enhance immune responses in mice, suggesting potential benefits for immune function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preclinical study of noopept toxicity]. Kovalenko, LP., Smol'nikova, NM., Alekseeva, SV., et al.[2017]

Citations

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The Effectiveness of Computerized Cognitive Training in ... We conclude that CCT can significantly enhance general cognitive function, attention, executive function, and quality of life in PSCI patients.

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The influence of eight cognitive training regimes upon ... This study aims to assess and compare the effectiveness of selected cognitive training methods for PSCI patients and to identify and rank the most effective ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422003044

The Preventing Alzheimer's with Cognitive Training (PACT) ... Thus, SPT indicates potential for functional benefits in addition to cognitive improvements, which is why it is likely to delay the onset of MCI and dementia.

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Can Cognitive Speed of Processing Training Improve ... The aim of these secondary analyses was to examine cognitive speed of processing training (SPT) gains in cognitive and everyday functioning among older adults.

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Implementation of a Cognitive Training Program to Reduce ... Also called a data safety and monitoring board, or DSMB. ... Measure the effectiveness of a cognitive training program on the post op cognitive dysfunction ...

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Efficacy of different digital interventions in patients with mild ... Previous research has shown that digital cognitive training is a promising, safe, and efficacious non-pharmacological treatment, but it is unclear which digital ...

9. withpower.com withpower.com/trial/phase-1-cognitive-dysfunction-8-2023-5ffef

Cognitive Training for Cognitive Impairment This Phase 1 medical study run by Stanford University is evaluating whether MLA and pSOPT will have tolerable side effects & efficacy for patients with ...