Mild Cognitive Impairment Community Screening and Early Intervention Via Stem Cell Therapy and Wearable Brain Computer Interface Device.

NCT07214974 | Not Yet Recruiting Early Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: NoahTechNTMCI0925
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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); Dementia (Diagnosis); Dementia MCI (Mild Cognitive Impairment); Mild Cognitive Impairment (MCI); Parkinson's Disease With Wearing-off Motor Fluctuations

Outcome Measures

Primary Outcomes (2)

• Change in Cognitive Function as Measured by MoCA Score

  The primary endpoint is the mean change from baseline in Montreal Cognitive Assessment (MoCA) total score, assessing domains such as memory, attention, language, and executive function. A clinically meaningful improvement is defined as an increase of ≥3 points, while decline indicates progression. This measure evaluates the efficacy of interventions in stabilizing or enhancing cognitive performance.

  Baseline, 6 months, 1 year, and annually up to 5 years.

• Rate of Progression to Dementia

  Proportion of participants progressing from MCI to dementia (e.g., Alzheimer's disease or other forms), diagnosed via DSM-5 criteria and confirmed by neuropsychological evaluation. This assesses intervention effectiveness in delaying or preventing cognitive decline.

  Assessed annually over 5 years.

Secondary Outcomes (3)

• Improvement in Neuropsychological Battery Scores

  Baseline, 6 months, 1 year, and annually up to 5 years.

• Change in Quality of Life

  Baseline, 6 months, 1 year, and annually up to 5 years.

• Early Detection Rate via Community Screening

  Enrollment phase (pre-randomization).

Other Outcomes (3)

• Epidemiological Characteristics of MCI

  Enrollment phase and baseline.

• Safety and Tolerability

  Throughout the 5-year study period, reported at each follow-up.

• Adherence to Interventions

  Ongoing, summarized annually over 5 years.

Study Arms (4)

Arm 1 (Control)

PLACEBO COMPARATOR

No active intervention; placebo procedures (e.g., saline infusions or sham devices)

Other: Control - Placebo Comparator

Arm 2 (Wellness Care)

ACTIVE COMPARATOR

Structured wellness programs comprising cognitive training exercises and life

Behavioral: Structured wellness care

Arm 3 (Stem Cell Therapy)

EXPERIMENTAL

Administration of autologous or allogeneic stem cells via intravenous or

Biological: Stem Cell Therapy - Experimental

Arm 4 (Wearable BCI Device Therapy)

EXPERIMENTAL

Use of an active non-invasive BCI device for neurofeedback trail

Device: Wearable brain-computer interface devices

Interventions

Wearable brain-computer interface devices 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.

Also known as: stem cell

Arm 4 (Wearable BCI Device Therapy)

Stem Cell Therapy - Experimental 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.

Arm 3 (Stem Cell Therapy)

Structured wellness care 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.

Also known as: Brain-computer Interface (BCI), Stem Cell, wearable BCI

Arm 2 (Wellness Care)

Control - Placebo Comparator 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.

Arm 1 (Control)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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)

Sponsors & Collaborators

• Noah Tech, Corp.: lead

Study Sites (1)

First Presbyterian Church

Palisades Park, New Jersey, 07650, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Parkinson Disease; Dementia; Disease

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Wallace Lynch, Ph.D.

CONTACT

6504895808; info@noahtech.life

Patrick M, BS

CONTACT

9174437199; help@noahtech.life

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In this double-blind trial, masking is limited to participants and outcomes assessors. No additional parties are masked. Blinding is maintained through the use of identical placebo saline infusions and sham (non-functional) devices across arms, prepared and distributed by an unblinded study coordinator. Intervention delivery is managed by a separate team from the blinded assessors to prevent unblinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This trial utilizes a parallel assignment model, wherein participants are concurrently randomized to one of four independent intervention arms (control, wellness care, stem cell therapy, or wearable BCI device therapy) for the duration of the study. This design facilitates direct comparisons of efficacy across groups without crossover or sequential elements, ensuring isolation of intervention effects on MCI progression over 5 years.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 9, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): January 3, 2030
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)