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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

Abstract

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).

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Acknowledgments

This study was a thesis of Dr. Mehdi Shafiee Sabet toward Iranian Board of Neurology under supervision of Prof. Shahin Akhondzadeh and Dr. Mohammad Hossein Harirchian at Tehran University of Medical Sciences.

Funding

This study was supported by two grants from Tehran University of Medical Sciences and Green Plants of Life Co., IMPIRAN to Prof. Shahin Akhondzadeh (Grant No: 8480).

Ethics approval

The protocol was approved by the Institutional Review Board (IRB) of Tehran University of Medical Sciences (Grant No. 8480).

The trial group

Shahin Akhondzadeh (principal investigator and statistical support, clinical neuropsychopharmacologist from January 2007 to February 2009)

Mansoureh Togha, Mohammad Hossein Harirchian, and Seyyed Shamssedin Hejazi (clinical coordinator, neurologist from January 2007 to February 2009)

Mehdi Shafiee Sabet, Hamed Cheraghmakani (trial programmer, resident of neurology from January 2007 to February 2009)

Aboulghasem Yousefi, Mohammad Hossein Yousefi, Farhad Zare, Atbin Moradi, Roozbeh Alimardani, and Ardalan Vossoughi (trialist, medical doctor from January 2007 to February 2009)

Amir Hossein Jamshidi, Shams-Ali Rezazadeh, and Soodeh Razeghi (pharmacognosist and nutritionist from January 2007 to February 2009)

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Correspondence to Shahin Akhondzadeh.

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Akhondzadeh, S., Shafiee Sabet, M., Harirchian, M.H. et al. A 22-week, multicenter, randomized, double-blind controlled trial of Crocus sativus in the treatment of mild-to-moderate Alzheimer’s disease. Psychopharmacology 207, 637–643 (2010). https://doi.org/10.1007/s00213-009-1706-1

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Keywords

  • Cholinesterase inhibitors
  • Crocus sativus
  • Clinical trial
  • Dementia