What this study is
This study aims to evaluate the efficacy of community-based early detection and targeted interventions, including stem cell therapy and wearable non-invasive brain-computer interface (BCI) devices, for Mild Cognitive Impairment (MCI) in adults aged 55 years and older residing in U.S. urban and suburban communities. Primary objectives include assessing improvements in MCI detection rates, cognitive outcomes, and progression delay compared to standard care.
What's being tested
- Structured wellness care
Intervention · BEHAVIORAL
Participants engage in structured wellness programs, including cognitive training exercises (e.g., memory games, problem-solving tasks) and lifestyle counseling focused on diet, physical exercise, sleep hygiene, and stress management. Sham elements may be included for blinding consistency.
- Wearable brain-computer interface devices
Intervention · DEVICE
Participants use an active non-invasive brain-computer interface (BCI) device for neurofeedback training, designed to enhance cognitive function through real-time brain activity monitoring and modulation. Sham (non-functional) devices are provided to other arms for blinding.
- Stem Cell Therapy - Experimental
Intervention · BIOLOGICAL
Participants receive administration of autologous or allogeneic stem cells through intravenous or targeted delivery methods aimed at neuroregeneration. Placebo saline infusions are used in other arms to preserve blinding.
- Control - Placebo Comparator
Intervention · OTHER
Participants receive no active treatment. To maintain blinding, they undergo placebo procedures, such as saline infusions mimicking stem cell therapy or sham (non-functional) devices simulating BCI therapy.
Study details
- Official title
- Mild Cognitive Impairment Community Screening, Early Detection, and Therapeutic Intervention to Slow Down, or Stop the Progression of the Cognitive Impairment.
- Sponsor
- Noah Tech, Corp.
- Conditions
- Mild Cognitive Impairment (MCI) · Early Stages of Cognitive Decline · Alzheimer's Disease Dementia · Alzheimer's Disease Diagnosis · Alzheimer's Disease and Related Dementias · Parkinson's Disease · Parkinson's Disease (PD) · Parkinson's Disease With Wearing-off Motor Fluctuations · Dementia (Diagnosis) · Dementia MCI (Mild Cognitive Impairment)
- Enrolling
- 600 people
- Starts
- 2026-01-03
- Est. completion
- 2030-01-03
- Design
- Double-blind, randomized, parallel groups, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 55 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- Adults aged 55 years and older Residents of U.S. urban or suburban communities Able to provide informed consent Willing to participate in 3-year follow-up assessments Able to complete cognitive screening assessments Access to transportation for community-based appointments No prior formal diagnosis of dementia
You can't join if
- Adults under 55 years of age Current diagnosis of moderate to severe dementia Severe psychiatric disorders that would interfere with assessment validity Active substance abuse disorders Severe visual or hearing impairments that cannot be corrected and would prevent assessment completion Terminal illness with life expectancy less than 3 years Current participation in other cognitive intervention research studies Inability to attend follow-up assessments due to geographic relocation plans Significant neurological conditions (stroke, traumatic brain injury, Parkinson's disease) that could confound cognitive assessment Institutionalized individuals (nursing home residents)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openFirst Presbyterian Church
Palisades Park, New Jersey, United States
Study team
Sponsor
Noah Tech, Corp.
Study ID NoahTech
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.