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

ConditionsMild Cognitive Impairment (MCI)Early Stages of Cognitive DeclineAlzheimer's Disease DementiaAlzheimer's Disease DiagnosisAlzheimer's Disease and Related DementiasParkinson's DiseaseParkinson's Disease (PD)Parkinson's Disease With Wearing-off Motor FluctuationsDementia (Diagnosis)Dementia MCI (Mild Cognitive Impairment)
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age55+
SponsorNoah Tech, Corp.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Vaccine

    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 intervention

    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.

Treatment groups

600 Participants
are divided into 4 treatment groups
Group A: Arm 1 (Control)Placebo comparator 1 intervention
Group B: Arm 2 (Wellness Care)Active comparator 1 intervention
Group C: Arm 3 (Stem Cell Therapy)Experimental treatment 1 intervention
Group D: Arm 4 (Wearable BCI Device Therapy)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Cognitive Function as Measured by MoCA Score

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.

Time frame
Baseline, 6 months, 1 year, and annually up to 5 years.
2

Rate of Progression to Dementia

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.

Time frame
Assessed annually over 5 years.

Secondary outcomes

1

Improvement in Neuropsychological Battery Scores

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.

Time frame
Baseline, 6 months, 1 year, and annually up to 5 years.
2

Change in Quality of Life

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.

Time frame
Baseline, 6 months, 1 year, and annually up to 5 years.
3

Early Detection Rate via Community Screening

Proportion of MCI cases identified through community-based MoCA screening compared to historical rates from standard clinical practices in similar populations.

Time frame
Enrollment phase (pre-randomization).

Other outcomes

1

Epidemiological Characteristics of MCI

Descriptive analysis of MCI prevalence, distribution patterns (e.g., by age, sex, urban/suburban residence, comorbidities), and risk factors in the screened cohort. This informs public health strategies.

Time frame
Enrollment phase and baseline.
2

Safety and Tolerability

Incidence and severity of adverse events (e.g., infusion reactions for stem cell therapy, device-related discomfort for BCI), graded per Common Terminology Criteria for Adverse Events (CTCAE).

Time frame
Throughout the 5-year study period, reported at each follow-up.
3

Adherence to Interventions

Percentage of completed sessions or device usage compliance, tracked via logs or electronic monitoring, to assess feasibility in real-world settings.

Time frame
Ongoing, summarized annually over 5 years.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Noah Tech, Corp.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: