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A Randomised Placebo-Controlled Study of Purified Anthocyanins on Cognition in Individuals at Increased Risk for Dementia.
Aarsland, D, Khalifa, K, Bergland, AK, Soennesyn, H, Oppedal, K, Holteng, LBA, Oesterhus, R, Nakling, A, Jarholm, JA, de Lucia, C, et al
The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry. 2023;31(2):141-151
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A growing body of evidence suggests that some modifiable factors, including cardiometabolic disorders such as hypertension, diabetes and hypercholesterolemia, as well as lifestyle factors such as physical exercise and diet, are associated with an increased risk of developing dementia. Anthocyanins, a flavonoid subclass found in dark berries and fruits, are among the dietary factors that may have positive effects on the pathogenesis of Alzheimer’s disease. The aim of this study was to assess whether anthocyanins can improve cognition and reduce the risk of dementia. This study is a 24-week randomised, double-blind, placebo-controlled Phase II study. Two-hundred and six participants were randomly assigned to one of the two groups: anthocyanins (n=106) or placebo (n=100). Results show that there wasn’t any significant group difference at the end of the study (24 weeks) in episodic memory (primary analysis) or for the secondary cognitive outcomes. However, there was a significant difference in slopes during weeks 8−24 where the anthocyanin group improved while the placebo group worsened. Furthermore, anthocyanin capsules were well-tolerated and safe to use. Authors conclude that future studies need to explore the potential mechanisms leading to cognitive improvement, how they relate to bioavailability of anthocyanins and metabolites, the optimal dosage, and the duration of treatment.
Abstract
IMPORTANCE Identifying nutritional compounds which can reduce cognitive decline in older people is a hugely important topic. OBJECTIVE To study the safety and effect of anthocyanins in maintaining cognitive functioning in people at increased risk for dementia. DESIGN, SETTING, AND PARTICIPANTS Participants (206 individuals, aged 60-80 years) diagnosed with either mild cognitive impairment (MCI) or two or more cardiometabolic disorders (i.e., diabetes, hypertension, obesity) were enrolled at three different centres in Norway. INTERVENTION Participants were randomly assigned to four capsules with a total of 320 mg/d of naturally purified anthocyanins or placebo 1:1 for 24 weeks. MAIN OUTCOMES AND MEASURES The primary outcome was the Quality of Episodic Memory composite measure (0-100) from an online cognitive test battery CogTrack, which was administered at baseline and monthly for the next 24 weeks. Secondary outcomes included other cognitive scores from the CogTrack battery. We applied mixed effects models with a baseline test score, group, time and their interaction as fixed effects, as well as other predefined baseline covariates. The primary comparison was the group difference at week 24 based on a modified intention-to-treat principle. RESULTS The primary analysis did not show a significant group difference at 24 weeks (78.2 versus 76.8; adjusted mean difference 1.4 (95% confidence interval -0.9-3.7); effect size 0.15; p = 0.23). However, there was a significant difference in slopes during weeks 8-24 (p = 0.007); the anthocyanin group improved while the placebo group worsened. No differences were found for the secondary cognitive outcomes. Anthocyanin capsules were well-tolerated and safe to use. CONCLUSION Anthocyanin supplementation for 24 weeks was safe and well tolerated in people with MCI or cardiometabolic disorders. We found no significant group difference in episodic memory at the end of the study but statistically significant differences in slopes. Further studies are warranted to explore whether anthocyanins supplementation can reduce cognitive decline in people at increased risk of dementia. TRIAL REGISTRATION ClinicalTrials.gov, (Identifier NCT03419039). http://www. CLINICALTRIALS gov/, NCT03419039.
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Quantifying dementia prevention potential in the FINGER randomized controlled trial using the LIBRA prevention index.
Deckers, K, Köhler, S, Ngandu, T, Antikainen, R, Laatikainen, T, Soininen, H, Strandberg, T, Verhey, F, Kivipelto, M, Solomon, A
Alzheimer's & dementia : the journal of the Alzheimer's Association. 2021;17(7):1205-1212
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Lifestyle interventions are being increasingly recognised to delay or prevent the onset of dementia. Scientific research targeting one lifestyle factor has continually failed to show any benefits and therefore interventions targeting several lifestyle factors, before disease onset may be more beneficial. The Lifestyle for BRAin Health (LIBRA) score is a tool which assesses peoples risk of dementia based on several lifestyle factors and this trial used this tool to determine the dementia risk of individuals who entered The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER). This study was the first randomised control trial showing benefits to cognition following multi-domain lifestyle interventions. The results showed that higher LIBRA score at the start of the trial was associated with poorer brain function over time and that the multi-domain lifestyle intervention was effective at decreasing LIBRA score, regardless of the risk at the start of the trial. It was concluded that LIBRA may be a useful tool to determine risk of dementia and that the FINGER intervention was of benefit to individuals regardless of their risk of dementia.
Abstract
INTRODUCTION Individuals in early dementia prevention trials may differ in how much they benefit from interventions depending on their initial risk level. Additionally, modifiable dementia risk scores might be used as surrogate/intermediate outcomes. METHODS In the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), we investigated in post hoc analyses (N = 1207) whether the cognitive benefits of the 2-year multi-domain lifestyle intervention differed by baseline dementia risk measured with the "LIfestyle for BRAin Health" (LIBRA) score. We also investigated intervention effects on change in LIBRA score over time. RESULTS Overall, higher baseline LIBRA was related to less cognitive improvement over time. This association did not differ between the intervention and control groups. The intervention was effective in decreasing LIBRA scores over time, regardless of baseline demographics or cognition. DISCUSSION The cognitive benefit of the FINGER intervention was similar across individuals with different LIBRA scores at baseline. Furthermore, LIBRA may be useful as a surrogate/intermediate endpoint and surveillance tool to monitor intervention success during trial execution.
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Effect of a Multidomain Lifestyle Intervention on Estimated Dementia Risk.
Solomon, A, Handels, R, Wimo, A, Antikainen, R, Laatikainen, T, Levälahti, E, Peltonen, M, Soininen, H, Strandberg, T, Tuomilehto, J, et al
Journal of Alzheimer's disease : JAD. 2021;82(4):1461-1466
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Early identification of individuals at-risk of dementia is essential for effective preventive strategies. The aim of this study was to investigate the effect of a multidomain lifestyle intervention on the risk of dementia. This study is a post-hoc analyses of intervention effects on change in the Cardiovascular Risk Factors, Aging and Dementia (CAIDE) Dementia Risk Score. The CAIDE score was used to select at-risk participants to the FINGER trial. FINGER is a multicentre study conducted in 6 centres in Finland. Results show a significant beneficial intervention effect, especially in women, on reducing estimated dementia risk measured by the CAIDE score. Authors conclude that CAIDE risk score can be used as a tool to communicate dementia risk, and to select persons that may benefit from lifestyle interventions.
Abstract
We investigated the effect of a multidomain lifestyle intervention on the risk of dementia estimated using the validated CAIDE risk score (post-hoc analysis). The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) is a 2-year randomized controlled trial among 1,260 at-risk older adults (60-77 years). Difference in the estimated mean change in CAIDE score at 2 years in the intervention compared to the control group was -0.16 (95 %CI -0.31 to 0.00) (p = 0.013), corresponding to a relative dementia risk reduction between 6.04-6.50%. This could be interpreted as a reflection of the prevention potential of the intervention.