There are limited pharmacological options currently available for the management of Alzheimer’s disease (AD) in severe stages. Herbal medicines have been used in the treatment of behavioural and psychological symptoms of dementia for years, but with variable response.

The cognitive-enhancing properties of Saffron, the dried stigma of Crocus Sativus L., have been evidenced in several different studies showing promising medicinal properties. Trials on the anti-Alzheimer effects of saffron on patients with moderate-to-severe Alzheimer’s disease demonstrate that it is more effective than placebo and appears as effective as Donepezil and Memantine; standard pharmaceutical drugs currently used for advanced ALZ dementia for cognition and dementia respectively.

Alzheimer’s disease is characterized by dementia that impacts memory, thinking, and behaviour which becomes serious enough to affect one’s daily life. Alzheimer’s is the cause of the ~ 70% of dementia cases. It predominantly affects people 65 years or older but can also occur as an “early onset” dementia form in younger people.

Alzheimer’s is a progressive disease, meaning it will not improve with treatment or time, and currently there is no known cure. Current treatments may slow the worsening of dementia symptoms and lead to an improvement in the overall quality of life for those suffering with Alzheimer’s, their families, and their health caregivers. A person with Alzheimer’s lives on average four to eight years after diagnosis but may live ~ 20 years depending on other surrounding factors.

Alzheimer’s is becoming the disease to be concerned with as our global population is aging. There is an estimated 50 million people living with dementia and ~ 10 million new cases of dementia reported each year worldwide. New diagnoses are rapidly increasing in heavily populated countries. When ALZ statistics are extrapolated to countries worldwide, approximately three quarters of people with dementia have not received a formal diagnosis yet, and therefore do not have access to treatment, care and organized support that getting a formal diagnosis can provide. Our global cost of dementia treatment is now above US$ trillion and growing!((Alzheimers Association and Global statistics
https://www.alz.org/alzheimers-dementia/what-is-alzheimers))Researchers involved in these studies—and still others on brain health—suspect that the effects of saffron may be effective against cognitive disorders because it may inhibit the overgrowth of amyloid β in the human brain.

This study follows two previous saffron trials on mild-to-moderate Alzheimer’s, in which saffron slowed cognitive decline compared to placebo or Donepezil, a drug intended to treat dementia. Forty-six patients with probable AD were screened for a 16-week, double-blind study of parallel groups of patients with mild to moderate AD. The psychometric measures, which included AD assessment scale-cognitive subscale (ADAS-cog), and clinical dementia rating scale-sums of boxes, were performed to monitor the global cognitive and clinical profiles of the patients. Patients were randomly assigned to receive capsule saffron 30 mg/day (15 mg twice per day) (Group A) or capsule placebo (two capsules per day) for a 16-week study. After 16 weeks, patients with the ‘saffron supplement’produced a significantly better outcome on cognitive function than the placebo.There were no significant differences in the two groups in terms of observed adverse events. This double-blind, placebo-controlled study suggests that at least in the short-term, saffron is both safe and effective in mild to moderate AD.Researchers suggested that Larger, confirmatory randomized controlled trials are called for.(( Akhondzadeh S1, Sabet MS, Harirchian MH, Togha M, Cheraghmakani H, Razeghi S, Hejazi SSh, Yousefi MH, Alimardani R, Jamshidi A, Zare F, Moradi A. Saffron in the treatment of patients with mild to moderate Alzheimer’s disease: a 16-week, randomized and placebo-controlled trial. J Clin Pharm Ther. 2010 Oct;35(5):581-8. doi: 10.1111/j.1365-2710.2009.01133.x.))

Another study compared the efficacy and safety of saffron extract versus Memantine in reducing cognitive deterioration of patients with moderate to severe AD. 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 recognized cognitive tests including the Severe Cognitive Impairment Rating Scale (SCIRS) and the Functional Assessment Staging Test (FAST), in addition to recording the probable adverse events.

The conclusion was both treatment groups showed similar outcomes as demonstrated by insignificant effect for time × treatment interaction on SCIRS. There was no significant difference between the two groups in the score changes from baseline to the endpoint on SCIRS and FAST. The frequency of side effectswere not significantly different between the two groups as well. In addition to its favorable safety profile, the 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 clinical sample sizes and longer follow-up periods are warranted.((Farokhnia M1, Shafiee Sabet M, Iranpour N, Gougol A, Yekehtaz H, Alimardani R, Farsad F, Kamalipour M, Akhondzadeh S. 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. Hum Psychopharmacol. 2014 Jul;29(4):351-9. doi: 10.1002/hup.2412.))

The purpose of another clinical investigation was to assess the efficacy of Saffron benefitsin the treatment of patients with mild-to-moderate AD in direct comparison to Donepezil.

Fifty-four Persian-speaking adults 55 years of age or older participated 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  Sum 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). Saffron at this dose was found to be effective and 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 exception of vomiting which occurred significantly more frequently in the donepezil pharmaceutical treated group. This phase II study provides preliminary evidence of possible beneficial effects of saffron extract in the treatment of patients with mild-to-moderate Alzheimer’s disease.((Akhondzadeh S1, Shafiee Sabet M, Harirchian MH, Togha M, Cheraghmakani H, Razeghi S, Hejazi SS, Yousefi MH, Alimardani R, Jamshidi A, Rezazadeh SA, Yousefi A, Zare F, Moradi A, Vossoughi A. A 22-week, multicenter, randomized, double-blind controlled trial of Crocus sativus in the treatment of mild-to-moderate Alzheimer’s disease. Psychopharmacology (Berl). 2010 Jan;207(4):637-43. doi: 10.1007/s00213-009-1706-1. Epub 2009 Oct 20.))

  1. Alzheimers Association and Global statistics

https://www.alz.org/alzheimers-dementia/what-is-alzheimers

  1. Akhondzadeh S1, Sabet MS, Harirchian MH, Togha M, Cheraghmakani H, Razeghi S, Hejazi SSh, Yousefi MH, Alimardani R, Jamshidi A, Zare F, Moradi A. Saffron in the treatment of patients with mild to moderate Alzheimer’s disease: a 16-week, randomized and placebo-controlled trial. J Clin Pharm Ther. 2010 Oct;35(5):581-8. doi: 10.1111/j.1365-2710.2009.01133.x.
  2. Farokhnia M1, Shafiee Sabet M, Iranpour N, Gougol A, Yekehtaz H, Alimardani R, Farsad F, Kamalipour M, Akhondzadeh S. 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. Hum Psychopharmacol. 2014 Jul;29(4):351-9. doi: 10.1002/hup.2412.
  3. Akhondzadeh S1, Shafiee Sabet M, Harirchian MH, Togha M, Cheraghmakani H, Razeghi S, Hejazi SS, Yousefi MH, Alimardani R, Jamshidi A, Rezazadeh SA, Yousefi A, Zare F, Moradi A, Vossoughi A. A 22-week, multicenter, randomized, double-blind controlled trial of Crocus sativus in the treatment of mild-to-moderate Alzheimer’s disease. Psychopharmacology (Berl). 2010 Jan;207(4):637-43. doi: 10.1007/s00213-009-1706-1. Epub 2009 Oct 20.

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