Validation of a Multidomain Neuropsychological Intervention for Individuals at Risk of Dementia: the REMINDER Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Blood biomarkers of neural damage
研究概览
简要总结
Until now, neuropsychological interventions aimed to optimize cognitive function and to have functional impact in individuals at risk of AD (MCI patients) were scarce in validity studies. While some RCTs have been developed in cognitive training interventions, comparative studies of merged interventions (cognitive, social and behavioral stimulation) with adequate control groups are absent, diminishing the professionals' trust on the adoption of these interventions for supporting patients. As such, the present proposal will develop a validation trial testing a multicomponent neuropsychological intervention (REMINDER), based on personal development, cognitive compensatory aids, meaningful goals setting, and behavior change techniques. The investigators will analyze its short/long-term gains and AD conversion rates. By aiming to provide a good validation study for REMINDER, the investigators will examine neurobiological, neurocognitive and functional outcomes of this intervention in comparison with an active control group (psychoeducation) in order to foster an effective outcome assessment of an intervention for individuals at risk of AD.
详细描述
The overarching tenet of this project is that, by providing a manualized multidomain intervention - REMINDER - that engages at risk individuals in the aims of this protocol, it can have a significant impact on health outcomes, optimizing healthier lifestyles and these being also understood along with the neurodegeneration signs of this impact.
The specific aims of this study will be:
- Recruit community-dwelling individuals with increased risk of dementia using CAIDE dementia risk score (with APOE, when available).
- Evaluate the REMINDER program (in comparison to an active control group (CT) - psychoeducation sessions) immediate effects regarding global cognition and functionality (primary outcomes) and neuropsychological, biochemical and neuroimaging outcomes (secondary outcomes).
- Determine the persistence of effects and begin characterizing the temporal course of putative benefits at 6-, and 18-months follow-up.
- Investigate the role of biomarkers (imaging and biochemical) in explaining the response to intervention and persistence of the effects and its correlation with neuropsychological and functionality measures.
- Measure the conversion rates from MCI to AD between the REMINDER and active control groups (at 24- months follow-up).
Our ultimate goal is to make available a scientifically validated and scalable intervention that helps prevent dementia in older adults at risk. By confirming the efficacy of REMINDER to prevent cognitive impairment and concluding for its medium-term efficacy to improve global cognitive function and healthy life habits the investigators are contributing to one of the WHO goals (Goal 3 - ensure healthy lives and promote well-being for all at all ages) by addressing risk reduction and management of a global health risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60 or older
- •CAIDE dementia risk score >8
- •Cognitive function: absence of significant cognitive impairment as per the Addenbrooke's Cognitive Examination-REVISED
- •Free of physical disabilities that preclude participation in the study
- •Willing to complete all study-related activities for 12 weeks
排除标准
- •Mild cognitive impairment or dementia;
- •Presence of any neurological event in their medical history that could compromise actual cognition.
- •Presence of any severe psychiatric disorder (mild depressive and anxiety symptoms meet inclusion criteria).
- •Unability to travel to the site where the sessions will be delivered (if so randomization will be circumscribed between the experimental harm REMINDER online and the control group.
- •Illiteracy
结局指标
主要结局
Blood biomarkers of neural damage
时间窗: Post intervention (1 week after the intervention sessions completion)
blood Neurofilament light chain (NfL) will be measured and tested as an outcome immediately after the intervention
Cognitive status composite
时间窗: Follow - up (24 months after the intervention)
A composite score including the individual scores with Addenbrooke's Cognitive Examination - Revised (ACE-R), that includes the Mini Mental State Examination - MMSE (screening tools to consider eligibility), Subjective Cognitive Decline Questionnaire (SCDQ), Trail Making Test A and B (TMT A \& B), Verbal Fluency - Phonemic (P, M and R) and Categories (Animals), Stroop Test, Free and Cued Selective Reminding Test (FCSRT) will be generated to work as primary outcome
Functionality status
时间窗: Follow - up (24 months after the intervention)
A composite score incorporating Adults and Older Adults Functional Assessment Inventory (IAFAI), University of California San Diego Performance-Based Skills Assessment (UPSA) will be used.
次要结局
- Brain changes(Post intervention (2 weeks after the intervention sessions completion))
- Mood status(Follow-up (12 months after the intervention))
- Perceived quality of life(Follow-up (12 months after the intervention))
- Perceived Self Efficacy(Follow-up (12 months after the intervention))
研究者
Ana Rita Silva
Principal Investigator
University of Coimbra