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

NCT ID: NCT07214974

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-03
• Study Completion Date: 2030-01-03

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.

Detailed Description

Study Objectives

The primary goal of this investigation is to assess the effectiveness of early MCI detection via community-based screening and subsequent interventions using stem cell therapy and wearable BCI devices. Specific research questions include:

Does community-based screening enhance early detection rates and diagnostic accuracy of MCI relative to conventional clinical practices? Do wellness care interventions post-MCI screening improve cognitive outcomes and delay progression to cognitive decline? What are the epidemiological characteristics and distribution patterns of MCI occurrence in the target population?

Study Design This is a prospective, multicenter, randomized, double-blind, placebo-controlled trial (RCT) designed to minimize bias and ensure methodological rigor.

Eligible participants will be identified through standardized cognitive screening (e.g., Montreal Cognitive Assessment [MoCA]) administered at community facilities and healthcare clinics. Inclusion criteria encompass adults aged ≥55 years with suspected or confirmed MCI, residing in U.S. urban or suburban areas, without contraindications to interventions. Exclusion criteria include severe dementia, active neurological disorders, or inability to provide informed consent.

Participants will be randomized to one of four parallel arms using a computer-generated sequence with stratified block randomization to balance covariates such as age, baseline MCI severity (e.g., MoCA score), and comorbidities. Allocation concealment will be maintained via sequentially numbered, opaque, sealed envelopes managed by an independent data coordinating center.

The intervention arms are defined as follows:

Arm 1 (Control): No active intervention; placebo procedures (e.g., saline infusions or sham devices) will be implemented to preserve blinding where applicable.

Arm 2 (Wellness Care): Structured wellness programs comprising cognitive training exercises and lifestyle counseling (e.g., diet, exercise, and sleep optimization), with sham components for blinding if required.

Arm 3 (Stem Cell Therapy): Administration of autologous or allogeneic stem cells via intravenous or targeted routes, with placebo saline infusions provided to non-stem cell arms.

Arm 4 (Wearable BCI Device Therapy): Use of an active non-invasive BCI device for neurofeedback training, with sham (non-functional) devices distributed to other arms.

Double-blinding will be achieved by ensuring that neither participants nor outcome assessors (e.g., neuropsychologists) are aware of group assignments. Intervention delivery will be handled by a separate team from the assessment personnel to prevent unblinding.

Follow-up evaluations will include periodic cognitive assessments (e.g., MoCA, comprehensive neuropsychological batteries) at baseline, 6 months, 1 year, and annually thereafter for a total duration of 5 years. These will monitor trajectories in cognitive function, MCI progression rates, and secondary endpoints such as quality of life (e.g., via SF-36 questionnaire), neuroimaging biomarkers (e.g., MRI volumetric changes), and biochemical markers (e.g., CSF amyloid-beta levels).

Statistical analysis will adhere to intention-to-treat principles. Inter-group comparisons will employ analysis of variance (ANOVA) or linear mixed-effects models for repeated measures, with adjustments for multiple comparisons (e.g., Bonferroni correction) and covariates. Survival analysis (e.g., Kaplan-Meier curves) will evaluate time-to-event outcomes, such as progression to dementia. Power calculations assume a sample size sufficient to detect a 20% difference in cognitive decline rates with 80% power and α=0.05.

This design facilitates an unbiased assessment of intervention efficacy in mitigating or reversing MCI progression, with potential implications for public health strategies in aging populations.

Last updated: October 03, 2025

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1 (Control)

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

Group Type: PLACEBO_COMPARATOR

Control - Placebo Comparator

Intervention Type: 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 2 (Wellness Care)

Structured wellness programs comprising cognitive training exercises and life

Group Type: ACTIVE_COMPARATOR

Structured wellness care

Intervention Type: 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.

Arm 3 (Stem Cell Therapy)

Administration of autologous or allogeneic stem cells via intravenous or

Group Type: EXPERIMENTAL

Stem Cell Therapy - Experimental

Intervention Type: 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 4 (Wearable BCI Device Therapy)

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

Group Type: EXPERIMENTAL

Wearable brain-computer interface devices

Intervention Type: 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.

Interventions

Structured wellness care

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.

Intervention Type: BEHAVIORAL

Wearable brain-computer interface devices

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.

Intervention Type: DEVICE

Stem Cell Therapy - Experimental

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.

Intervention Type: BIOLOGICAL

Control - Placebo Comparator

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.

Intervention Type: OTHER

Other Intervention Names

Brain-computer Interface (BCI); Stem Cell; wearable BCI; stem cell

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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)

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Noah Tech, Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Presbyterian Church

Palisades Park, New Jersey, United States

Countries

United States

Central Contacts

Wallace Lynch, Ph.D.

Role: CONTACT

info@noahtech.life

6504895808

Patrick M, BS

Role: CONTACT

help@noahtech.life

9174437199

Other Identifiers

NTMCI0925

Identifier Type: OTHER

Identifier Source: secondary_id

NoahTech

Identifier Type: -

Identifier Source: org_study_id