Psychopharmacology

, Volume 207, Issue 4, pp 637–643

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

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

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).

Keywords

Cholinesterase inhibitors Crocus sativus Clinical trial Dementia 

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Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Shahin Akhondzadeh
    • 1
    • 2
  • Mehdi Shafiee Sabet
    • 3
  • Mohammad Hossein Harirchian
    • 3
  • Mansoreh Togha
    • 3
  • Hamed Cheraghmakani
    • 3
  • Soodeh Razeghi
    • 3
  • Seyyed Shamssedin Hejazi
    • 4
  • Mohammad Hossein Yousefi
    • 4
  • Roozbeh Alimardani
    • 2
  • Amirhossein Jamshidi
    • 5
  • Shams-Ali Rezazadeh
    • 2
  • Aboulghasem Yousefi
    • 1
  • Farhad Zare
    • 1
  • Atbin Moradi
    • 1
  • Ardalan Vossoughi
    • 1
  1. 1.Psychiatric Research Center, Roozbeh Psychiatric HospitalTehran University of Medical SciencesTehranIran
  2. 2.Institute of Medicinal Plants (ACECR)TehranIran
  3. 3.Department of NeurologyTehran University of Medical SciencesTehranIran
  4. 4.Department of NeurologyQom University of Medical SciencesTehranIran
  5. 5.Office for Herbal DrugsMinistry of Health and Medical EducationTehranIran

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