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A 22-week, multicenter, randomized, double-blind controlled trial of Crocus sativus in the treatment of mild-to-moderate Alzheimer’s disease


Akhondzadeh, Shahin, Shafiee Sabet, Mehdi, Harirchian, Mohammad Hossein, Togha, Mansoreh, Cheraghmakani, Hamed, Razeghi, Soodeh, Hejazi, Seyyed Shamssedin, Yousefi, Mohammad Hossein, Alimardani, Roozbeh, Jamshidi, Amirhossein, Rezazadeh, Shams-Ali, Yousefi, Aboulghasem, Zare, Farhad, Moradi, Atbin, Vossoughi, Ardalan


Psychopharmacology, Volume: 207, No.: 4, Pages.: 637-643

Year of Publication



Rationale: There is increasing evidence to suggest the possible efficacy of Crocus sativus (saffron) in the management of Alzheimer’s disease (AD).; Objective: The purpose of the present investigation was to assess the efficacy of C. sativus in the treatment of patients with mild-to-moderate AD.; Methods: Fifty-four Persian-speaking adults 55 years of age or older who were living in the community were eligible to participate in a 22-week, double-blind study of parallel groups of patients with AD. The main efficacy measures were the change in the Alzheimer’s Disease Assessment Scale-cognitive subscale and Clinical Dementia Rating Scale-Sums of Boxes scores compared with baseline. Adverse events (AEs) were systematically recorded. Participants were randomly assigned to receive a capsule saffron 30 mg/day (15 mg twice per day) or donepezil 10 mg/day (5 mg twice per day).; Results: Saffron at this dose was found to be effective similar to donepezil in the treatment of mild-to-moderate AD after 22 weeks. The frequency of AEs was similar between saffron extract and donepezil groups with the exception of vomiting, which occurred significantly more frequently in the donepezil group.; Conclusion: This phase II study provides preliminary evidence of a possible therapeutic effect of saffron extract in the treatment of patients with mild-to-moderate Alzheimer’s disease. This trial is registered with the Iranian Clinical Trials Registry (IRCT138711051556N1).;

Bibtex Citation

@article{Akhondzadeh_2009, doi = {10.1007/s00213-009-1706-1}, url = {}, year = 2009, month = {oct}, publisher = {Springer Science $mathplus$ Business Media}, volume = {207}, number = {4}, pages = {637--643}, author = {Shahin Akhondzadeh and Mehdi Shafiee Sabet and Mohammad Hossein Harirchian and Mansoreh Togha and Hamed Cheraghmakani and Soodeh Razeghi and Seyyed Shamssedin Hejazi and Mohammad Hossein Yousefi and Roozbeh Alimardani and Amirhossein Jamshidi and Shams-Ali Rezazadeh and Aboulghasem Yousefi and Farhad Zare and Atbin Moradi and Ardalan Vossoughi}, title = {A 22-week, multicenter, randomized, double-blind controlled trial of Crocus sativus in the treatment of mild-to-moderate Alzheimer's disease}, journal = {Psychopharmacology} }


adverse effects, aged, alzheimer disease, chemistry, cholinesterase inhibitors, crocus, donezepil, double-blind method, drug therapy, female, humans, indans, iran, male, physiopathology, piperidines, plant extracts, psychiatric status rating scales, saffron, severity of illness index, therapeutic use

Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes


Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

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