A nutrient-packed drink may have some limited benefit in people with prodromal Alzheimer’s disease (AD), but experts urge caution in drawing any firm conclusions.
Over 2 years, the daily nutritional drink (vs inactive control drink) had no significant impact on performance on the neuropsychological test battery (NTB), the primary endpoint, or on conversion to dementia in patients with prodromal AD. However, some evidence suggested less worsening in Clinical Dementia Rating-Sum of Boxes (CDR-SB) score and a slowing of hippocampal atrophy.
The study was published online October 30 in Lancet Neurology.
Mixed Results
LipiDiDiet is a research consortium funded by the European Union that studies the impact of nutrition in AD. The nutritional drink tested in the study is available in the United Kingdom as Souvenaid (Nutricia).
Fortasyn Connect, the active component of Souvenaid, was developed on the basis of the premise that a specific combination of nutrients enhances synaptic functions. It contains docosahexaenoic acid and eicosapentaenoic acid; uridine monophosphate; choline; vitamins B12, B6, C, and E, and folic acid; phospholipids; and selenium.
The LipiDiDiet trial, conducted at 11 centers in Finland, Germany, the Netherlands, and Sweden, enrolled 311 patients aged 55 to 85 years who met criteria for prodromal AD; 153 were randomly allocated to the active intervention (125 mL once-daily drink containing Fortasyn Connect) and 158 to an inactive isocaloric control drink.
There was no statistically significant difference between groups in the primary endpoint, mean change in a composite score of cognitive performance based on the NTB (–0.028 in the intervention group and –0.108 in the control group; estimated mean treatment difference, 0.098; 95% confidence interval [CI], –0.041 to 0.237; P = .166). The researchers note that the decline in NTB in the control group was less than the prestudy estimate of –0.4 over 24 months, rendering this analysis statistically underpowered.
Two secondary endpoints showed a difference in favor of the nutritional drink. The CDR-SB score worsened less in the active group over the study period, with an effect size of 0.33 (P = .005).
“The worsening in CDR-SB was 45% less in the active group than in the control group, based on the estimated change from baseline over 24 months,” the researchers report. Supplementation with the nutritional drink also slowed hippocampal atrophy rate, with an effect size of 0.22 (P = .005).
During the 24-month study period, 62 (41%) patients in the active group and 59 (37%) in the control group were diagnosed with dementia. Sixty-six (21%) patients dropped out of the study. Serious adverse events occurred in 34 (22%) patients in the active group and 30 (19%) in the control group, none of which were considered related to the study intervention.
“Further study of nutritional approaches with larger sample sizes, longer duration, or a primary endpoint more sensitive in this pre-dementia population, is needed,” the authors conclude in their article.
In a press release, Hilkka Soininen, PhD, from the University of Eastern Finland in Kuopio, who led the trial, said these results are “extremely valuable as they bring us closer to understanding the impact of nutritional interventions on prodromal Alzheimer’s, which we are now better at diagnosing but unable to treat due to a lack of approved pharmaceutical options. The LipiDiDiet study illustrates that this nutritional intervention can help to conserve brain tissue and also memory and patients’ ability to perform everyday tasks — possibly the most troubling aspects of the disease.”
No Proof of Efficacy
In a comment published with the study, Hussein Yassine, MD, from Keck School of Medicine University of California, Los Angeles, urges caution in interpreting the findings.
This trial, together with past trials, “does not provide sufficient evidence for the use of Fortasyn Connect in mild or prodromal Alzheimer’s disease. The suggestion of benefit in two of the secondary outcomes is encouraging, but needs to be confirmed in further research,” he writes.
Maria C. Carrillo, PhD, Alzheimer’s Association chief science officer, also urged caution in interpreting the study results.
“This study failed to meet its primary endpoint. This product has not been proven efficacious,” she told Medscape Medical News.
Dr Carrillo also noted that the finding of reduction in functional decline and brain atrophy relative to the control group should be viewed only as “scientific points of interest. The results reported in the article may provide information and direction for future studies that will give us more definitive information about efficacy in these populations.”
The Alzheimer’s Association recently launched the Protect through a Lifestyle Intervention to Reduce Risk (US POINTER) study, a 2-year clinical trial to test whether lifestyle interventions focused on combining healthy nutrition, physical activity, social and intellectual challenge, and increased medical monitoring of vascular and metabolic conditions can protect cognitive function in older adults at increased risk for cognitive decline.
“US POINTER is the first study to examine this combined multi-dimensional intervention in a large-scale U.S.-based population,” Dr Carrillo said.
The LipiDiDiet trial was funded by the European Commission 7th Framework Programme. Several authors have indicated financial relationships with pharmaceutical companies. All are listed with the original article. Dr Yassine has received grants from the Alzheimer’s Association. Dr Carrillo has disclosed no relevant financial relationships.
Lancet Neurol. Published online October 30, 2017. Abstract, Comment
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