Comparing the efficacy and safety of Crocus sativus L. with memantine in patients with moderate to severe Alzheimer's disease: a double‐blind randomized clinical trial

Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, IranObjectives Limited pharmacological options are available for the management of Alzheimer’s disease (AD) in severe stages. Cognitive-enhancing properties of saffron, the dried stigma of Crocus sativus L., have been evidenced in different studies. We aimed to compare theefficacy and safety of saffron extract versus memantine in reducing cognitive deterioration of patients with moderate to severe AD.Methods In this randomized double-blind parallel-group study, 68 patients with moderate to severe AD (Mini-Mental StateExamination scoreof8–14)receivedmemantine(20mg/day)orsaffronextract(30mg/da y)capsulesfor12months.Participantswereevaluatedeverymonth by Severe Cognitive Impairment Rating Scal e (SCIRS) and Functional Assessment Staging (FAST) in addition to recording the probableadverse events.Results Bothtreatmentgroupsshowedsimilaroutcomesasdemonstratedbyinsignificanteffectfortime×treatmentinteractiononSCIRSscores[F(2.95,194.78)=2.25, p=0.08].TherewasnosignificantdifferencebetweenthetwogroupsinthescoreschangesfrombaselinetotheendpointonSCIRS (p=0.38) and FAST (p=0.87). The frequency of adverse events was not signi ficantly different between the two groups as well.Conclusions In addition to its favorable safety profile, 1-year administration of saffron extract capsules showed to be comparable withmemantine in reducing cognitive decline in patients with moderate to severe AD. Confirmatory studies with larger sample sizes and longerfollow-up periods are warranted. Copyright © 2014 John Wiley & Sons, Ltd.key words—saffron; memantine; Alzheimer’s disease; Crocus sativus L.; glutamate