Mild Cognitive Impairment Community Screening, Early Detection, and Therapeutic Intervention to Slow Down, or Stop the Progression of the Cognitive Impairment.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change in Cognitive Function as Measured by MoCA Score
研究概览
简要总结
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.
详细描述
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. Specific research questions include:
Does community-based screening enhance early detection rates and diagnostic accuracy of MCI relative to conventional clinical practices? Do wellness care interventions post-MCI screening improve cognitive outcomes and delay progression to cognitive decline? What are the epidemiological characteristics and distribution patterns of MCI occurrence in the target population?
Study Design This is a prospective, multicenter, randomized, double-blind, placebo-controlled trial (RCT) designed to minimize bias and ensure methodological rigor.
Eligible participants will be identified through standardized cognitive screening (e.g., Montreal Cognitive Assessment [MoCA]) administered at community facilities and healthcare clinics. Inclusion criteria encompass adults aged ≥55 years with suspected or confirmed MCI, residing in U.S. urban or suburban areas, without contraindications to interventions. Exclusion criteria include severe dementia, active neurological disorders, or inability to provide informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
In this double-blind trial, masking is limited to participants and outcomes assessors. No additional parties are masked. Blinding is maintained through the use of identical placebo saline infusions and sham (non-functional) devices across arms, prepared and distributed by an unblinded study coordinator. Intervention delivery is managed by a separate team from the blinded assessors to prevent unblinding.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Arm 1 (Control)
No active intervention; placebo procedures (e.g., saline infusions or sham devices)
干预措施: Control - Placebo Comparator (Other)
Arm 2 (Wellness Care)
Structured wellness programs comprising cognitive training exercises and life
干预措施: Structured wellness care (Behavioral)
Arm 3 (Stem Cell Therapy)
Administration of autologous or allogeneic stem cells via intravenous or
干预措施: Stem Cell Therapy - Experimental (Biological)
Arm 4 (Wearable BCI Device Therapy)
Use of an active non-invasive BCI device for neurofeedback trail
干预措施: Wearable brain-computer interface devices (Device)
结局指标
主要结局
Change in Cognitive Function as Measured by MoCA Score
时间窗: 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
时间窗: 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.
次要结局
- Improvement in Neuropsychological Battery Scores(Baseline, 6 months, 1 year, and annually up to 5 years.)
- Change in Quality of Life(Baseline, 6 months, 1 year, and annually up to 5 years.)
- Early Detection Rate via Community Screening(Enrollment phase (pre-randomization).)