Starting soon
Phase EARLY_PHASE1
Mild Cognitive Impairment Community Screening and Early Intervention Via Stem Cell Therapy and Wearable Brain Computer Interface Device.
Condition(s) studied
Mild 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)
Investigational drug(s) / intervention(s)
Structured wellness careWearable brain-computer interface devicesStem Cell Therapy - ExperimentalControl - Placebo Comparator
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.
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.
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.
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.
Study 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.
Eligibility
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)
Primary outcome measure(s)
- 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| First Presbyterian Church |
Palisades Park |
New Jersey |
|