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NOT YET RECRUITING
NCT07214974
EARLY_PHASE1

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

Sponsor: Noah Tech, Corp.

View on ClinicalTrials.gov

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.

Official title: Mild Cognitive Impairment Community Screening, Early Detection, and Therapeutic Intervention to Slow Down, or Stop the Progression of the Cognitive Impairment.

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2026-09-01

Completion Date

2030-01-03

Last Updated

2026-03-10

Healthy Volunteers

Yes

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.

Locations (1)

First Presbyterian Church

Palisades Park, New Jersey, United States