RightFit
Not yet recruitingEarly Phase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device, Infusions, MRI scans, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study Objectives The primary goal of this investigation is to assess the effectiveness of early MCI detection via community-based screening and subsequent interventions using stem cell therapy and wearable BCI devices."
  • "Arm 3 (Stem Cell Therapy): Administration of autologous or allogeneic stem cells via intravenous or targeted routes, with placebo saline infusions provided to non-stem cell arms."
  • "Arm 4 (Wearable BCI Device Therapy): Use of an active non-invasive BCI device for neurofeedback training, with sham (non-functional) devices distributed to other arms."
  • "These will monitor trajectories in cognitive function, MCI progression rates, and secondary endpoints such as quality of life (e.g., via SF-36 questionnaire), neuroimaging biomarkers (e.g., MRI volumetric changes), and biochemical markers (e.g., CSF amyloid-beta levels)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests community screening and early treatments for mild cognitive impairment, which means mild problems with memory and thinking. Treatments include stem cell therapy and wearable devices that link brain signals to a computer without surgery. It is for adults age 55 and older in U.S. cities and suburbs, and compares these methods with usual care to see if they improve detection and thinking skills and slow worsening.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 55 or older.
  • Live in a U.S. city or suburb.
  • Can understand the study and agree to take part.
  • Willing to take part in follow-up checks for 3 years.
  • Can complete memory and thinking tests.
  • Have transportation to community appointments.
  • Have never had a formal diagnosis of dementia.

Who can't join

  • Under age 55 or currently diagnosed with moderate to severe dementia.
  • Have a severe mental health condition that would affect test results, or an active substance use disorder.
  • Have severe vision or hearing problems that cannot be corrected and prevent testing.
  • Have a terminal illness with an expected lifespan of less than 3 years.
  • Are taking part in another study of treatments for memory or thinking.
  • Plan to move away and cannot attend follow-up checks.
  • Have a major brain or nerve condition, such as stroke, brain injury, or Parkinson’s disease, that could affect test results.
  • Live in a nursing home or another care institution.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (1)

NJ