The COMFORTage Project: Integration of Multiple Sources Towards Personalized Preventions at Ace Alzheimer Center Barcelona
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes in neuropsychological assessment
研究概览
简要总结
The COMFORTage study at Ace Alzheimer Center Barcelona is investigating whether a personalized cognitive and functional stimulation program can help slow cognitive decline in individuals diagnosed with mild cognitive impairment (MCI) or mild Alzheimer's disease (AD) dementia.
The study involves 100 participants aged 60 to 85, who are randomly assigned to one of two groups. The active group receives weekly in-person sessions for one year, featuring individualized cognitive and physical training through digital platforms developed by the COMFORTage project. The control group does not participate in the training but undergoes the same schedule of health assessments and monitoring.
All participants are followed for a total of two years. Throughout the study, researchers collect comprehensive clinical, neuropsychological, and biological data. This includes cognitive assessments, magnetic resonance imaging (MRI) brain scans, blood and cerebrospinal fluid (CSF) samples, and genetic testing. In addition, participants complete spontaneous speech recordings from home every 3-4 months using a dedicated mobile application.
The primary objective is to determine whether the stimulation program more effectively preserves memory and cognitive function compared to no intervention. The study also evaluates its impact on physical and emotional well-being, daily functioning, and quality of life. Insights from the trial will contribute to the development of an artificial intelligence (AI)-powered digital health platform aimed at delivering personalized care for individuals living with dementia.
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
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 60 and 85 years.
- •Diagnosis of MCI based on Petersen criteria with a CDR score of 0.
- •Diagnosis of mild AD dementia according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria with a CDR score of
- •Proficiency in using digital tools such as mobile apps, tablets, or computers.
- •Ability and willingness to attend regular in-person sessions at Ace Alzheimer Center Barcelona.
- •Provided written informed consent after receiving a full explanation of the study.
排除标准
- •History of traumatic brain injury.
- •Diagnosis of severe depression.
- •History of stroke or brain tumors.
- •Presence of significant uncorrected visual or auditory impairments.
- •Lack of access to a digital device or internet connection.
- •Inability to participate in regular in-person sessions at the study site.
- •Any medical condition that may confound cognitive assessment or limit participation.
结局指标
主要结局
Changes in neuropsychological assessment
时间窗: Baseline, 1-year follow-up, and 2-year follow-up
Assesses the change in cognitive function over two years using composite scores from the Neuropsychological Battery used at Ace (NBACE). The scores evaluate five domains: attention, memory, visuospatial/visuoperceptual functions, executive functions, and language. The scores for each domain range from -3 (low competence) to 3 (high competence).
次要结局
- Change in Mini-Mental State Examination (MMSE) score(Baseline, 1-year follow-up, and 2-year follow-up)
- Change in Memory Test Score from the 7-Minute Screen Test (Spanish version)(Baseline, 1-year follow-up, and 2-year follow-up)
- Change in Hachinski Ischemia Scale score(Baseline, 1-year follow-up, and 2-year follow-up)
- Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) score(Baseline, 1-year follow-up, and 2-year follow-up)
- Change in Global Deterioration Scale (GDS) score(Baseline, 1-year follow-up, and 2-year follow-up)
- Change in Clinical Dementia Rating (CDR) score(Baseline, 1-year follow-up, and 2-year follow-up)
- Change in Blessed Dementia Scale score(Baseline, 1-year follow-up, and 2-year follow-up)
- Change in Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) score(Baseline, 1-year follow-up, and 2-year follow-up)
- Change in Cumulative Illness Rating Scale (CRIS) score(Baseline, 1-year follow-up, and 2-year follow-up)
- Change in body weight(Baseline, 1-year follow-up, and 2-year follow-up)
- Change in body height(Baseline, 1-year follow-up, and 2-year follow-up)
- Change in abdominal circumference(Baseline, 1-year follow-up, and 2-year follow-up)
- Change in blood pressure(Baseline, 1-year follow-up, and 2-year follow-up)
- Questionnaire for User Interaction Satisfaction (QUIS)(Baseline, 1-year follow-up, and 2-year follow-up)
- 5-level EQ-5D (EQ5D5L) questionnaire(Baseline, 1-year follow-up, and 2-year follow-up)
- Change in concentration of plasma biomarkers(Baseline, 1-year follow-up, and 2-year follow-up)
- Basal evaluation of CSF biomarkers(Once at the beginning of the study)