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

Not Applicable

Not yet recruiting

• Conditions: Mild Cognitive Impairment (MCI); Alzheimer's Disease Diagnosis; Dementia MCI (Mild Cognitive Impairment); Early Stages of Cognitive Decline; Alzheimer's Disease and Related Dementias; Alzheimer's Disease Dementia; Parkinson's Disease; Parkinson's Disease (PD); Parkinson's Disease With Wearing-off Motor Fluctuations; Dementia (Diagnosis)
• Interventions: Other: Control - Placebo Comparator; Behavioral: Structured wellness care; Biological: Stem Cell Therapy - Experimental; Device: Wearable brain-computer interface devices

• Registration Number: NCT07214974
• Lead Sponsor: Noah Tech, Corp.

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

Study Timeline

• Study First Submitted: 2025-09-18
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-08
• Last Update Submitted: 2025-10-08
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Study Start: 2026-01-03
• Primary Completion: 2029-01-03
• Study Completion: 2030-01-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 (Control)	Control - Placebo Comparator	No active intervention; placebo procedures (e.g., saline infusions or sham devices)
Arm 2 (Wellness Care)	Structured wellness care	Structured wellness programs comprising cognitive training exercises and life
Arm 3 (Stem Cell Therapy)	Stem Cell Therapy - Experimental	Administration of autologous or allogeneic stem cells via intravenous or
Arm 4 (Wearable BCI Device Therapy)	Wearable brain-computer interface devices	Use of an active non-invasive BCI device for neurofeedback trail

Primary Outcome Measures

Name	Time	Method
Change in Cognitive Function as Measured by MoCA Score	Baseline, 6 months, 1 year, and annually up to 5 years.	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.
Rate of Progression to Dementia	Assessed annually over 5 years.	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in Neuropsychological Battery Scores	Baseline, 6 months, 1 year, and annually up to 5 years.	Changes in composite scores from a standardized neuropsychological test battery (e.g., including Rey Auditory Verbal Learning Test for memory, Trail Making Test for executive function, and Boston Naming Test for language). This provides detailed insights into specific cognitive domain improvements.
Change in Quality of Life	Baseline, 6 months, 1 year, and annually up to 5 years.	Assessed using the Short Form-36 (SF-36) questionnaire, focusing on physical and mental health components. This evaluates the broader impact of interventions on daily functioning and well-being.
Early Detection Rate via Community Screening	Enrollment phase (pre-randomization).	Proportion of MCI cases identified through community-based MoCA screening compared to historical rates from standard clinical practices in similar populations.

Trial Locations

Locations (1)

First Presbyterian Church; 🇺🇸 Palisades Park, New Jersey, United States