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

Part of paid clinical trials in Palisades Park, New Jersey.

Sponsor
Noah Tech, Corp.
Study ID
NCT07214974
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Alzheimer's Disease Dementia
  • Alzheimer's Disease Diagnosis
  • Alzheimer's Disease and Related Dementias
  • Dementia (Diagnosis)
  • Dementia MCI (Mild Cognitive Impairment)
  • Early Stages of Cognitive Decline
  • Mild Cognitive Impairment (MCI)
  • Parkinson's Disease
  • Parkinson's Disease (PD)
  • Parkinson's Disease With Wearing-off Motor Fluctuations

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2029
Completion
Jan 3, 2030

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Change in Cognitive Function as Measured by MoCA Score [ Time Frame: Baseline, 6 months, 1 year, and annually up to 5 years. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
First Presbyterian ChurchPalisades ParkNew Jersey07650-

Find similar trials in Palisades Park, NJ

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
First Presbyterian Church· Palisades Park, NJ

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