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000164588 1001_ $$aSchwarz, Claudia$$b0
000164588 245__ $$aEffects of Spermidine Supplementation on Cognition and Biomarkers in Older Adults With Subjective Cognitive Decline: A Randomized Clinical Trial.
000164588 260__ $$aChicago, Ill.$$bAmerican Medical Association$$c2022
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000164588 520__ $$aDeveloping interventions against age-related memory decline and for older adults experiencing neurodegenerative disease is one of the greatest challenges of our generation. Spermidine supplementation has shown beneficial effects on brain and cognitive health in animal models, and there has been preliminary evidence of memory improvement in individuals with subjective cognitive decline.To determine the effect of longer-term spermidine supplementation on memory performance and biomarkers in this at-risk group.This 12-month randomized, double-masked, placebo-controlled phase 2b trial (the SmartAge trial) was conducted between January 2017 and May 2020. The study was a monocenter trial carried out at an academic clinical research center in Germany. Eligible individuals were aged 60 to 90 years with subjective cognitive decline who were recruited from health care facilities as well as through advertisements in the general population. Data analysis was conducted between January and March 2021.One hundred participants were randomly assigned (1:1 ratio) to 12 months of dietary supplementation with either a spermidine-rich dietary supplement extracted from wheat germ (0.9 mg spermidine/d) or placebo (microcrystalline cellulose). Eighty-nine participants (89%) successfully completed the trial intervention.Primary outcome was change in memory performance from baseline to 12-month postintervention assessment (intention-to-treat analysis), operationalized by mnemonic discrimination performance assessed by the Mnemonic Similarity Task. Secondary outcomes included additional neuropsychological, behavioral, and physiological parameters. Safety was assessed in all participants and exploratory per-protocol, as well as subgroup, analyses were performed.A total of 100 participants (51 in the spermidine group and 49 in the placebo group) were included in the analysis (mean [SD] age, 69 [5] years; 49 female participants [49%]). Over 12 months, no significant changes were observed in mnemonic discrimination performance (between-group difference, -0.03; 95% CI, -0.11 to 0.05; P = .47) and secondary outcomes. Exploratory analyses indicated possible beneficial effects of the intervention on inflammation and verbal memory. Adverse events were balanced between groups.In this randomized clinical trial, longer-term spermidine supplementation in participants with subjective cognitive decline did not modify memory and biomarkers compared with placebo. Exploratory analyses indicated possible beneficial effects on verbal memory and inflammation that need to be validated in future studies at higher dosage.ClinicalTrials.gov Identifier: NCT03094546.
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000164588 650_7 $$2NLM Chemicals$$aBiomarkers
000164588 650_7 $$0U87FK77H25$$2NLM Chemicals$$aSpermidine
000164588 650_2 $$2MeSH$$aAged
000164588 650_2 $$2MeSH$$aAnimals
000164588 650_2 $$2MeSH$$aBiomarkers
000164588 650_2 $$2MeSH$$aCognition: physiology
000164588 650_2 $$2MeSH$$aCognitive Dysfunction: drug therapy
000164588 650_2 $$2MeSH$$aDietary Supplements
000164588 650_2 $$2MeSH$$aFemale
000164588 650_2 $$2MeSH$$aHumans
000164588 650_2 $$2MeSH$$aInflammation
000164588 650_2 $$2MeSH$$aNeurodegenerative Diseases
000164588 650_2 $$2MeSH$$aSpermidine: pharmacology
000164588 650_2 $$2MeSH$$aSpermidine: therapeutic use
000164588 7001_ $$aBenson, Gloria S$$b1
000164588 7001_ $$aHorn, Nora$$b2
000164588 7001_ $$aWurdack, Katharina$$b3
000164588 7001_ $$aGrittner, Ulrike$$b4
000164588 7001_ $$aSchilling, Ralph$$b5
000164588 7001_ $$aMärschenz, Stefanie$$b6
000164588 7001_ $$aKöbe, Theresa$$b7
000164588 7001_ $$aHofer, Sebastian J$$b8
000164588 7001_ $$aMagnes, Christoph$$b9
000164588 7001_ $$aStekovic, Slaven$$b10
000164588 7001_ $$aEisenberg, Tobias$$b11
000164588 7001_ $$0P:(DE-2719)2811106$$aSigrist, Stephan$$b12$$udzne
000164588 7001_ $$0P:(DE-2719)2810725$$aSchmitz, Dietmar$$b13$$udzne
000164588 7001_ $$0P:(DE-2719)2814122$$aWirth, Miranka$$b14$$udzne
000164588 7001_ $$aMadeo, Frank$$b15
000164588 7001_ $$0P:(DE-2719)2812683$$aFlöel, Agnes$$b16$$eLast author$$udzne
000164588 773__ $$0PERI:(DE-600)2931249-8$$a10.1001/jamanetworkopen.2022.13875$$gVol. 5, no. 5, p. e2213875 -$$n5$$pe2213875$$tJAMA network open$$v5$$x2574-3805$$y2022
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