PDF(Pubmed)
Abstract：
The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) showed cognitive benefits from a multidomain lifestyle intervention in at-risk older people. The LipiDiDiet trial highlighted benefits of medical food in prodromal Alzheimer\'s disease (AD). However, the feasibility and impact of multimodal interventions combining lifestyle with medical food in prodromal AD is unclear.
MIND-ADmini was a 6-month multinational (Sweden, Finland, Germany, France) proof-of-concept randomized controlled trial (RCT). Participants were 60-85 years old, had prodromal AD (International Working Group-1 criteria), and vascular/lifestyle risk factors. The parallel-group RCT had three arms: multimodal lifestyle intervention (nutritional guidance, exercise, cognitive training, vascular/metabolic risk management and social stimulation); multimodal lifestyle intervention + medical food (Fortasyn Connect); and regular health advice/care (control). Participants were randomized 1:1:1 (computer-generated allocation at each site). Outcome evaluators were blinded to randomization. Primary outcome was feasibility of the multimodal intervention, evaluated by recruitment rate during a 6-month recruitment phase, overall adherence in each intervention arm, and 6-month retention rate. Successful adherence was pre-specified as attending ≥ 40% of sessions/domain in ≥ 2/4 domains (lifestyle intervention), and consuming ≥ 60% of the medical food (lifestyle intervention + medical food). The secondary outcomes included adherence/participation to each intervention component and overall adherence to healthy lifestyle changes, measured using a composite score for healthy lifestyle. Cognitive assessments were included as exploratory outcomes, e.g. Clinical Dementia Rating scale.
During September 2017-May 2019, 93 individuals were randomized (32 lifestyle intervention, 31 lifestyle + medical food, and 30 control group). Overall recruitment rate was 76.2% (64.8% during the first 6 months). Overall 6-month retention rate was 91.4% (lifestyle intervention 87.5%; lifestyle + medical food 90.3%; control 96.7%). Domain-specific adherence in the lifestyle intervention group was 71.9% to cognitive training, 78.1% exercise, 68.8% nutritional guidance, and 81.3% vascular risk management; and in the lifestyle + medical food group, 90.3% to cognitive training, 87.1% exercise, 80.7% nutritional guidance, 87.1% vascular risk management, and 87.1% medical food. Compared with control, both intervention arms showed healthy diet improvements (βLifestyle×Time = 1.11, P = 0.038; βLifestyle+medical food×Time = 1.43, P = 0.007); the lifestyle + medical food group also showed vascular risk reduction (P = 0.043) and less cognitive-functional decline (P < 0.05, exploratory analysis). There were 5 serious adverse events (control group: 1; lifestyle intervention: 3; lifestyle + medical food: 1) unrelated to interventions.
The multidomain lifestyle intervention, alone or combined with medical food, had good feasibility and adherence in prodromal AD. Longer-term cognitive and other health benefits should be further investigated in a larger-scale trial.
ClinicalTrials.gov NCT03249688.
MIND-ADmini was a 6-month multinational (Sweden, Finland, Germany, France) proof-of-concept randomized controlled trial (RCT). Participants were 60-85 years old, had prodromal AD (International Working Group-1 criteria), and vascular/lifestyle risk factors. The parallel-group RCT had three arms: multimodal lifestyle intervention (nutritional guidance, exercise, cognitive training, vascular/metabolic risk management and social stimulation); multimodal lifestyle intervention + medical food (Fortasyn Connect); and regular health advice/care (control). Participants were randomized 1:1:1 (computer-generated allocation at each site). Outcome evaluators were blinded to randomization. Primary outcome was feasibility of the multimodal intervention, evaluated by recruitment rate during a 6-month recruitment phase, overall adherence in each intervention arm, and 6-month retention rate. Successful adherence was pre-specified as attending ≥ 40% of sessions/domain in ≥ 2/4 domains (lifestyle intervention), and consuming ≥ 60% of the medical food (lifestyle intervention + medical food). The secondary outcomes included adherence/participation to each intervention component and overall adherence to healthy lifestyle changes, measured using a composite score for healthy lifestyle. Cognitive assessments were included as exploratory outcomes, e.g. Clinical Dementia Rating scale.
During September 2017-May 2019, 93 individuals were randomized (32 lifestyle intervention, 31 lifestyle + medical food, and 30 control group). Overall recruitment rate was 76.2% (64.8% during the first 6 months). Overall 6-month retention rate was 91.4% (lifestyle intervention 87.5%; lifestyle + medical food 90.3%; control 96.7%). Domain-specific adherence in the lifestyle intervention group was 71.9% to cognitive training, 78.1% exercise, 68.8% nutritional guidance, and 81.3% vascular risk management; and in the lifestyle + medical food group, 90.3% to cognitive training, 87.1% exercise, 80.7% nutritional guidance, 87.1% vascular risk management, and 87.1% medical food. Compared with control, both intervention arms showed healthy diet improvements (βLifestyle×Time = 1.11, P = 0.038; βLifestyle+medical food×Time = 1.43, P = 0.007); the lifestyle + medical food group also showed vascular risk reduction (P = 0.043) and less cognitive-functional decline (P < 0.05, exploratory analysis). There were 5 serious adverse events (control group: 1; lifestyle intervention: 3; lifestyle + medical food: 1) unrelated to interventions.
The multidomain lifestyle intervention, alone or combined with medical food, had good feasibility and adherence in prodromal AD. Longer-term cognitive and other health benefits should be further investigated in a larger-scale trial.
ClinicalTrials.gov NCT03249688.
摘要：
背景：芬兰预防认知障碍和残疾的老年干预研究（FINGER）显示，在有风险的老年人中，多领域生活方式干预的认知益处。LipiDiDiet试验强调了医疗食品在前驱阿尔茨海默病（AD）中的益处。然而,多模式干预结合生活方式和医疗食品治疗前驱AD的可行性和影响尚不清楚.
方法：MIND-ADmini是一家为期6个月的跨国公司(瑞典，芬兰,德国,法国)概念验证随机对照试验(RCT)。参与者年龄为60-85岁，患有前驱AD（国际工作组-1标准），和血管/生活方式风险因素。平行组RCT有三组：多模式生活方式干预(营养指导，锻炼,认知训练,血管/代谢风险管理和社会刺激）；多模式生活方式干预+医疗食品（FortasynConnect）；和定期健康建议/护理（控制）。参与者以1：1：1（每个站点的计算机生成分配）进行随机化。结果评估者对随机化是盲目的。主要结果是多模式干预的可行性，按6个月招聘阶段的招聘率进行评估，每个干预组的总体依从性，和6个月的保留率。成功的依从性被预先指定为在≥2/4领域（生活方式干预）中参加≥40％的会话/领域，消耗≥60%的医疗食品(生活方式干预+医疗食品)。次要结果包括对每个干预组成部分的依从性/参与度以及对健康生活方式改变的总体依从性。使用健康生活方式的综合评分进行测量。认知评估作为探索性结果，例如临床痴呆评定量表。
结果：在2017年9月至2019年5月期间，93名个体被随机分配（32个生活方式干预，31生活方式+医疗食品，和30个对照组)。总体招聘率为76.2%(前6个月为64.8%)。总体6个月保留率为91.4%(生活方式干预87.5%;生活方式+医疗食品90.3%;对照组96.7%)。生活方式干预组特定领域对认知训练的依从性为71.9%，78.1％的运动，68.8%的营养指导,和81.3%的血管风险管理；在生活方式+医疗食品组中，90.3%用于认知训练，87.1％的运动，80.7%营养指导,87.1%血管风险管理,和87.1%的医疗食品。与对照相比，两个干预组显示出健康的饮食改善(β生活方式×时间=1.11,P=0.038;β生活方式+医疗食物×时间=1.43,P=0.007);生活方式+医疗食物组也显示出血管风险降低(P=0.043)和认知功能下降较少(P<0.05,探索性分析).有5例严重不良事件(对照组:1例;生活方式干预:3例;生活方式+医疗食品:1)与干预无关。
结论：多领域生活方式干预，单独或与医疗食品结合，在前驱AD中具有良好的可行性和依从性。长期认知和其他健康益处应在更大规模的试验中进一步研究。
背景：ClinicalTrials.govNCT03249688。
方法：MIND-ADmini是一家为期6个月的跨国公司(瑞典，芬兰,德国,法国)概念验证随机对照试验(RCT)。参与者年龄为60-85岁，患有前驱AD（国际工作组-1标准），和血管/生活方式风险因素。平行组RCT有三组：多模式生活方式干预(营养指导，锻炼,认知训练,血管/代谢风险管理和社会刺激）；多模式生活方式干预+医疗食品（FortasynConnect）；和定期健康建议/护理（控制）。参与者以1：1：1（每个站点的计算机生成分配）进行随机化。结果评估者对随机化是盲目的。主要结果是多模式干预的可行性，按6个月招聘阶段的招聘率进行评估，每个干预组的总体依从性，和6个月的保留率。成功的依从性被预先指定为在≥2/4领域（生活方式干预）中参加≥40％的会话/领域，消耗≥60%的医疗食品(生活方式干预+医疗食品)。次要结果包括对每个干预组成部分的依从性/参与度以及对健康生活方式改变的总体依从性。使用健康生活方式的综合评分进行测量。认知评估作为探索性结果，例如临床痴呆评定量表。
结果：在2017年9月至2019年5月期间，93名个体被随机分配（32个生活方式干预，31生活方式+医疗食品，和30个对照组)。总体招聘率为76.2%(前6个月为64.8%)。总体6个月保留率为91.4%(生活方式干预87.5%;生活方式+医疗食品90.3%;对照组96.7%)。生活方式干预组特定领域对认知训练的依从性为71.9%，78.1％的运动，68.8%的营养指导,和81.3%的血管风险管理；在生活方式+医疗食品组中，90.3%用于认知训练，87.1％的运动，80.7%营养指导,87.1%血管风险管理,和87.1%的医疗食品。与对照相比，两个干预组显示出健康的饮食改善(β生活方式×时间=1.11,P=0.038;β生活方式+医疗食物×时间=1.43,P=0.007);生活方式+医疗食物组也显示出血管风险降低(P=0.043)和认知功能下降较少(P<0.05,探索性分析).有5例严重不良事件(对照组:1例;生活方式干预:3例;生活方式+医疗食品:1)与干预无关。
结论：多领域生活方式干预，单独或与医疗食品结合，在前驱AD中具有良好的可行性和依从性。长期认知和其他健康益处应在更大规模的试验中进一步研究。
背景：ClinicalTrials.govNCT03249688。
