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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


Farokhnia, Mehdi, Shafiee Sabet, Mehdi, Iranpour, Negar, Gougol, Amirhossein, Yekehtaz, Habibeh, Alimardani, Roozbeh, Farsad, Farzaneh, Kamalipour, Maryam, Akhondzadeh, Shahin


Human Psychopharmacology: Clinical and Experimental, Volume: 29, No.: 4, Pages.: 351-359

Year of Publication



Objectives 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 the efficacy 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 State Examination score of 8–14) received memantine (20 mg/day) or saffron extract (30 mg/day) capsules for 12 months. Participants were evaluated every month by Severe Cognitive Impairment Rating Scale (SCIRS) and Functional Assessment Staging (FAST) in addition to recording the probable adverse events. Results Both treatment groups showed similar outcomes as demonstrated by insignificant effect for time × treatment interaction on SCIRS scores [F(2.95, 194.78) = 2.25, p = 0.08]. There was no significant difference between the two groups in the scores changes from baseline to the endpoint on SCIRS (p = 0.38) and FAST (p = 0.87). The frequency of adverse events was not significantly 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 with memantine in reducing cognitive decline in patients with moderate to severe AD. Confirmatory studies with larger sample sizes and longer follow‐up periods are warranted. Copyright © 2014 John Wiley & Sons, Ltd. (PsycINFO Database Record (c) 2014 APA, all rights reserved). (journal abstract)

Bibtex Citation

@article{Farokhnia_2014, doi = {10.1002/hup.2412}, url = {}, year = 2014, month = {jul}, publisher = {Wiley-Blackwell}, volume = {29}, number = {4}, pages = {351--359}, author = {Mehdi Farokhnia and Mehdi Shafiee Sabet and Negar Iranpour and Amirhossein Gougol and Habibeh Yekehtaz and Roozbeh Alimardani and Farzaneh Farsad and Maryam Kamalipour and Shahin Akhondzadeh}, title = { Comparing the efficacy and safety of Crocus sativus L. with memantine in patients with moderate to severe Alzheimer{textquotesingle}s disease: a double-blind randomized clinical trial }, journal = {Human Psychopharmacology: Clinical and Experimental} }


adverse, alzheimer’s disease, cognitive decline, cognitive impairment, crocus sativus, drug therapy, efficacy safety, events, medicinal herbs and plants, memantine, safety, saffron

Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Cognition, Other

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime, Herbal remedies, vitamins, dietary supplements