Evaluating the Efficacy of AI-Augmented Cognitive Rehabilitation in Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change in MoCA-BLIND Score at 6 Months
研究概览
简要总结
Mild cognitive impairment (MCI) is associated with increased risk of progression to dementia, highlighting the need for accessible interventions to support cognitive health.
This randomized controlled trial will evaluate the safety and efficacy of a 12-month artificial intelligence (AI)-supported cognitive rehabilitation program for older adults with MCI. Participants will be recruited from an existing research study conducted within Kaiser Permanente Southern California and randomized 1:1 to either (1) AI-supported cognitive rehabilitation or (2) usual care alone.
The intervention combines clinician-delivered telehealth cognitive rehabilitation sessions with daily AI-guided cognitive exercises and education. The primary outcome is change in global cognition at 6 months measured by the Montreal Cognitive Assessment (MoCA)-BLIND. Secondary outcomes at 6 and 12 months include additional measures of cognition, subjective memory, goal attainment, mood, and loneliness. Exploratory outcomes include engagement with the AI intervention and health-related behavioral outcomes derived from electronic health record data.
Participant safety will be monitored throughout the study through adverse event tracking, review of AI interactions for safety concerns, and predefined procedures for responding to psychological or clinical risk.
This study will determine whether integrating AI-guided cognitive exercises with clinician-delivered rehabilitation improves cognitive and related outcomes in older adults with MCI compared to usual care.
详细描述
Background and Rationale:
Mild cognitive impairment (MCI) represents a transitional stage between normal aging and dementia and is associated with elevated risk of progression to Alzheimer's disease and related dementias. Individuals with MCI frequently report functional challenges, reduced confidence, and increased risk of mood symptoms. Although cognitive rehabilitation and cognitive stimulation interventions have demonstrated benefit, traditional models are resource-intensive and limited in frequency, personalization, and scalability.
Advances in artificial intelligence (AI) allow delivery of adaptive, conversational, and personalized cognitive exercises at high frequency. However, AI-only approaches may lack the contextualization, goal-setting support, and therapeutic oversight provided by trained clinicians. A blended care model integrating AI-guided cognitive exercises with clinician-delivered telehealth rehabilitation may provide both scalability and clinical depth. This study evaluates the safety, engagement, and clinical efficacy of such an integrated model.
Study Design:
This is a prospective, randomized parallel controlled trial conducted within Kaiser Permanente Southern California. Participants diagnosed with MCI through an existing cognitive assessment research program will be randomized in a 1:1 ratio to:
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 (Investigator, Outcomes Assessor)
盲法说明
Outcome assessors and the Principal Investigator will remain blinded to treatment assignment. Intervention delivery will be conducted by designated unblinded study personnel who are not involved in outcome assessment or outcome analysis.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •Diagnosis of mild cognitive impairment (MCI)
- •Montreal Cognitive Assessment (MoCA)-BLIND adjusted score (13-18)
- •Able to provide informed consent
- •English fluency sufficient to complete study assessments and participate in intervention sessions
- •Access to and ability to use a computer or mobile device with internet connectivity
排除标准
- •Current receipt of ongoing behavioral health treatment or psychotherapy from a Kaiser Permanente clinician
- •Diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other serious mental illness that would interfere with participation
- •Significant communication impairment that would prevent participation in conversational or telehealth sessions
研究组 & 干预措施
Usual Care
Participants will continue to receive usual health care and services available through their Kaiser Permanente health plan and will complete study assessments at 6 and 12 months.
AI-Supported Cognitive Rehabilitation
Participants will receive a 12-month cognitive rehabilitation program that integrates clinician-delivered telehealth sessions with daily artificial intelligence (AI)-guided cognitive exercises.
干预措施: AI-Supported Cognitive Rehabilitation (Behavioral)
结局指标
主要结局
Change in MoCA-BLIND Score at 6 Months
时间窗: 6 months
Change from baseline to 6 months on the Montreal Cognitive Assessment (MoCA)-BLIND adjusted total score.
次要结局
- Change in Global Cognition (MoCA-BLIND)(12 months)
- Change in Global Cognition (ACE-III)(6 months and 12 months)
- Change in Subjective Memory(6 months and 12 months)
- Change in Mood Symptoms(6 months and 12 months)
- Change in Loneliness(6 months and 12 months)
- Change in Goal Attainment(6 months and 12 months)
研究者
Huong Q Nguyen
Research Scientist III
Kaiser Permanente