A Home-based Personalized Multidomain RCT from the Canadian Therapeutic Platform for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 275
- 试验地点
- 11
- 主要终点
- Change in global cognition assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13)
研究概览
简要总结
In Canada, 1,700,000 adults are at risk of dementia, half of them with MCI,representing one of the largest groups at risk for an incurable disease. Epidemiological evidence suggests up to 40% of dementia cases might be preventable by targeting modifiable lifestyle and cardiovascular factors. Given that current treatments cannot modify the disease, prevention is critical. SYNERGIC-2 offers a "personalized multidomain intervention" that combines physical and cognitive training, sleep, diet, and vascular-metabolic interventions in individuals with MCI to synergistically enhance their overall brain health including cognition and contributes to maintaining their independence. Importantly, interventions will be provided at home using an existing virtual platform reducing delivery complexity and expanding the accessibility to a wider population, thus decreasing potential inequities. Improving older adults' brain health and achieving even a modest two-year dementia incidence delay will have a projected saving of $218 Billion in Canada's healthcare system over 30 years.
详细描述
Epidemiological evidence suggests up to 40% of potential dementia cases might be preventable by targeting modifiable lifestyle and cardiovascular factors; given that current treatments cannot modify the disease, prevention is a critical aspect. SYNERGIC-2 is the first large Canadian clinical trial using a 12-month home-based personalized multidomain lifestyle intervention to improve cognition in 550 older adults with Mild Cognitive Impairment (MCI), a pre-dementia state. These personalized at-home interventions target 5 domains with tailored physical exercise, cognitive training, diet recommendations, sleep interventions, and vascular risk factor management and are all delivered using a digital platform. Specifically, SYNERGIC-2 will be conducted with participants in their homes using video-conference meetings to test participants and to coach them 1-on-1 through the interventions on a web-based digital platform. The effect of these combined interventions on cognition will be compared to an online-educational program Brain Health PRO (BHPro). Both interventions are part of CAN-THUMBS UP, the interventional platform of the CCNA related to Canada Dementia Research Strategy; and constitutes Canada's contribution to the World-Wide-FINGERS Network. Importantly, these interventions have been selected because there is evidence that they synergistically enhance overall brain health including cognition and contributes to maintaining independence for individuals at risk for developing dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Ages 60-85 years.
- •Having mild cognitive impairment (MCI) defined as meeting all of the following:
- •Presence of subjective memory complaints from the participant and/or informant.
- •Objective impairment on cognitive tests independent of outcome measures.†
- •Preserved activities of daily living assessed (>14/23 in Lawton-Brody IADL score). For the study, impairment of daily living will be assessed based on cognitive abilities, not physical abilities.
- •Absence of clinical dementia per DSM-IV criteria †Objective cognitive impairment is operationalized as: Montreal Cognitive Assessment (MoCA) total score between 16 and 25 (inclusive), and/or RAVLT delayed recall ≤6, and /or Clinical Dementia Rating Scale (CDR) =0.5
- •Have ≥1 additional dementia risk factors targeted by our intervention as follows: low physical activity (less than 150 minutes of moderate-to-vigorous-intensity physical activity per week, as per GAQ), poor diet (14-item Mediterranean Diet Assessment (MDA-14) score ≤7), insomnia or subthreshold insomnia ( Insomnia Severity Index (ISI) score >7), and vascular-metabolic risk (Cardiovascular Risk Factors Aging and Incidence of Dementia (CAIDE) score ≥6 and/or diabetes (type I or II) and/or obesity (BMI≥30) and/or diagnosis of high blood pressure (hypertension) and/or smoking).
- •Have access to a home computer/laptop/tablet with home internet (have regular access to email) and ability to use technology (able to send and receive emails and join video conferences).
- •Self-reported levels of proficiency in English for speaking and understanding spoken and written language.
- •Have normal/corrected to normal vision in at least one eye to identify stimuli on computer/tablet screen.
- •Have normal to corrected hearing ability, in order for the participant to engage in digital/virtual communication. Research personnel will determine and assess the hearing ability as per participant's performance.
- •Able to comply with virtual visits, treatment plan, and trial-related activities.
- •Ability to participate in the study's exercise training as determined by the Get Active Questionnaire (GAQ).
排除标准
- •Having a diagnosis of dementia (based on DSM-IV criteria).
- •Underlying severe disease that precludes engagement with interventions, including presence of psychiatric diagnoses (i.e., major depression (Geriatric Depression Scale (GDS-30) >19), schizophrenia, severe anxiety, neurological disorder with severe motor deficits, such as current parkinsonism or any neurological disorder with residual severe motor deficits (i.e., stroke with motor deficit), or presence of unstable (non-controlled e.g., symptoms that suggest instability or no treatment for their condition) chronic disease such as congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) that may preclude the participant from engaging properly with the trial interventions, or advanced-stage active cancer that at the study physician's discretion will prevent them from participating.
- •Having had surgery within the last 2 months or having an upcoming planned surgery in the next 12 months that could interfere with the participant's vision, hearing, mobility, or any other abilities to participate in the study.
- •Regular use of Benzodiazepine or neuroleptic drugs that may interfere with the participants ability to participate in the assessments and interventions.
- •Recent (in the past 12 months) and/or current substance or alcohol abuse.
- •Having had a transmural myocardial infarction (severe heart attack) within six months prior to enrollment in the clinical trial that according to the study physician may preclude physical activity performance.
- •Intention to enroll in other interventional clinical trials during same time.
结局指标
主要结局
Change in global cognition assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13)
时间窗: baseline and at 48 weeks (after interventions finalized)
Global cognition will be assessed using the cognitive section of the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13). This scale consists of 13 brief cognitive tests assessing attention, memory, language, executive function, praxis, orientation, and instrumental activities of daily living. The ADAS-Cog has been a significant outcome measure in numerous trials with MCI and AD to measure changes in cognitive performance in populations with cognitive impairment, it score ranges from 0 to 84, with higher scores indicating worse cognitive performance.
次要结局
- Changes in Digit Symbol Modalities Test - Oral Version (mental processing speed)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in Eating Pattern Self-Assessment(Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months)
- Changes in Insomnia Severity Index(Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months)
- Changes in International Physical Activity Questionnaire scores(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in Health Resource Utilization Questionnaire (HRUQ)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in the Lawton-Brody Instrumental Activities of Daily Living (IADL) scale(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in the Mediterranean Diet Assessment(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in Quality of Life Questionnaire (SF-36)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in the Cognitive Expectancies Questionnaire(Baseline and follow-up at 12 months)
- Changes in sleep pattern(Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months)
- Identification of APO-E variants, a planned panel of 31 single nucleotide polymorphisms (SNPs), and untargeted metabolomics(Baseline and follow-up at 12 months)
- Change in Anthropometric Measures(Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months)
- Changes in the CCNA Gait Assessments results-Walking performance(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in Clinical Dementia Rating scores(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in Fall Occurrence(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in Generalized Anxiety Disorder (GAD-7)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Change in Geriatric Depression Scale (GDS-30)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Change in Health Utility Index (HUI-3)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in global cognitive function using Montreal Cognitive Assessment(MoCA)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in the Oral Trail Making Test - Attention Shifting capabilities/executive functions using(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Change in Cardiovascular Risk Factors, Aging, and Incidence of Dementia(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in EEG(Baseline and follow-up at 12 months)
- Changes in Rey Auditory Verbal Learning Test (RAVLT)-Episodic memory(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in behavior(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in physical activity in the elderly(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in BHPro questionnaires(Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months)
- Changes in Resource Use Inventory Q7 & Q8 (RUI Q7 &Q8)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in 60s Chair Standing Test(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in The Activities-specific Balance Confidence Scale (ABC) questionnaire(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in The Short Physical Performance Battery (SPPB)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)