Integrating a multimodal lifestyle intervention with medical food in prodromal Alzheimer's disease: the MIND-ADmini randomized controlled trial.

BACKGROUND: 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. METHODS: 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. RESULTS: 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 (ßLifestyle×Time = 1.11, P = 0.038; ßLifestyle+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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT03249688.

Everyday Life Meaningfulness for the Community-Dwelling Oldest Old During the COVID-19 Pandemic.

In many countries, the COVID-19 pandemic has led to strong restrictions and changed the everyday lives of older people. In Finland, people aged 70 and over were instructed to stay at home under quarantine-like conditions. Existing studies from other countries have reported increases in negative experiences and symptoms as a result of such restrictions, including psychosocial stress. However, little focus has been given to older people's experiences of meaningfulness during the pandemic. Using survey and interview data, we ask to what extent have community-dwelling oldest old (80+) experienced meaningfulness during the pandemic, what background factors are associated with meaningfulness and what factors have contributed to everyday life meaningfulness during the pandemic. The data was collected as part of the COVID-19 sub-study of the third follow-up of the Cardiovascular Risk Factors, Aging and Dementia (CAIDE85+) study, a Finnish population-based cohort study carried out in the eastern part of the country. In the quantitative analyses, meaningfulness was assessed as part of the Experiences of Social Inclusion Scale. The association of meaningfulness with different background factors (gender, age, living alone, self-chosen quarantine or physical isolation, self-rated health, physical functioning, and cognitive capacity) was explored with the Chi-square test. The quantitative findings indicate that the majority of the participants experienced meaningfulness during the pandemic. Participants who did not practice any physical isolation measures and participants with higher self-rated health experienced more meaningfulness. There was no evidence for difference in the prevalence of meaningfulness and other background factors. The qualitative data was analyzed using thematic analysis. The findings indicated that factors contributing to meaningfulness in everyday life were social contacts, daily chores and activities, familiar places and seasonal changes. The small sample size does not provide possibilities for generalizing the results into the wider population of older adults. However, the results provide new understanding of the oldest old's experiences of meaningfulness in everyday life during the global pandemic. The findings may help find ways to support older people's meaningfulness in challenging times.