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

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

• 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)

Interventions

BEHAVIORAL

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.

DEVICE

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.

BIOLOGICAL

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.

OTHER

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.

Sponsors & Collaborators

• Noah Tech, Corp.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2029-09-30

Completion

2030-01-03

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations