Stem Cell Therapy + Brain-Computer Interface for Mild Cognitive Impairment

(MCITestCare Trial)

PM
WL
Overseen ByWallace Lynch, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Noah Tech, Corp.

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to assist individuals with Mild Cognitive Impairment (MCI), an early stage of memory loss or thinking problems. Researchers are testing stem cell therapy and a wearable brain-computer interface (BCI) device to determine if they can enhance mental function and slow progression compared to standard care. Participants will be divided into four groups: one with structured wellness programs, another receiving stem cell therapy, a third using the BCI device, and a control group with no active treatment. This trial suits adults aged 55 and older, living in urban or suburban areas, who have noticed memory issues but haven't been diagnosed with dementia. As an Early Phase 1 trial, this research aims to understand how these innovative treatments work in people, offering participants a chance to be among the first to receive potentially groundbreaking therapies.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

In earlier studies, stem cell therapy has shown promise for being safe in patients with conditions like Mild Cognitive Impairment. Research suggests that stem cell therapy is safe for Alzheimer's patients, with some trials indicating it may help slow memory loss and brain shrinkage within nine months of treatment. This means the therapy is generally well-tolerated, with no major safety concerns reported.

Recent reviews show that wearable brain-computer interface (BCI) devices are safe and effective at translating brain signals into commands for external devices. Although the technology is still being improved, studies have not identified significant safety issues with wearable BCIs.

Overall, both treatments in this trial have demonstrated safety in similar situations, although specific details on side effects were not provided.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for mild cognitive impairment because they offer new approaches beyond the standard care, which usually involves medications like cholinesterase inhibitors and lifestyle interventions. Stem cell therapy is unique because it uses autologous or allogeneic stem cells, which might help repair damaged brain cells and improve cognitive function. Meanwhile, the wearable brain-computer interface (BCI) device therapy is groundbreaking as it provides non-invasive neurofeedback, potentially enhancing brain activity and memory. These innovative methods target the brain's healing and adaptive capacities in ways traditional treatments do not, offering hope for more effective management of cognitive decline.

What evidence suggests that this trial's treatments could be effective for Mild Cognitive Impairment?

Research has shown that stem cell therapy, which participants in this trial may receive, can improve thinking and memory in people with mild cognitive impairment (MCI). It may work by repairing damaged nerve cells and reducing brain swelling. For individuals with Alzheimer's, stem cell therapy has improved brain health and thinking skills, which could also benefit those with MCI.

Wearable brain-computer interface (BCI) devices, another treatment option in this trial, also show promise in enhancing brain function. These devices aim to improve focus and memory by providing real-time feedback on brain activity. Early research suggests that BCIs can differentiate between various types of cognitive issues, making them a useful tool for managing MCI.12346

Are You a Good Fit for This Trial?

Adults aged 55+ with Mild Cognitive Impairment (MCI) living in U.S. urban or suburban areas are eligible for this trial. It's designed to help detect MCI early and test new treatments. People with Parkinson's, Alzheimer's, dementia, or thalassemia can join too.

Inclusion Criteria

Residents of U.S. urban or suburban communities
Able to provide informed consent
Willing to participate in 3-year follow-up assessments
See 4 more

Exclusion Criteria

Active substance abuse disorders
Severe psychiatric disorders that would interfere with assessment validity
Terminal illness with life expectancy less than 3 years
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive interventions including stem cell therapy, wellness care, or wearable BCI device therapy

6 months
Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Stem Cell Therapy
  • Structured wellness care
  • Wearable brain-computer interface devices
Trial Overview The study is testing stem cell therapy and wearable brain-computer interface devices against a placebo and standard wellness care to see if they improve detection rates of MCI and cognitive outcomes or delay its progression.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Arm 4 (Wearable BCI Device Therapy)Experimental Treatment1 Intervention
Group II: Arm 3 (Stem Cell Therapy)Experimental Treatment1 Intervention
Group III: Arm 2 (Wellness Care)Active Control1 Intervention
Group IV: Arm 1 (Control)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Noah Tech, Corp.

Lead Sponsor

Citations

Study Details | NCT07214974 | Mild Cognitive Impairment ...This study aims to evaluate the efficacy of community-based early detection and targeted interventions, including stem cell therapy and ...
Stem cell therapy use in patients with dementia: a systematic ...Stem cell therapy (SCT) is increasingly recognized for its potential in managing cognitive impairment, particularly that of dementia.
Allogeneic mesenchymal stem cell therapy with ...The study findings support the potential for laromestrocel to improve both cognitive function and QoL in mild AD. Furthermore, detailed brain- ...
Stem Cell Therapy for Alzheimer's: Findings and Treatment ...Research suggests stem cell therapy may improve brain health by reducing swelling, repairing damaged nerve cells, and improving cognitive function in people ...
Stem cells in the treatment of Alzheimer's diseaseAD is characterized by the initial preclinical stage, mild cognitive impairment (MCI) ... Results showed improved cognitive functions in AD patients because ...
Stem cells therapy in neurodegenerative and ...A single transplantation of HSPCs can prevent microglia activation, completely prevent memory loss and neurocognitive impairment in AD mice, reduce Aβ plaques ...
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