Safety and efficacy of rosmarinic acid in patients with Alzheimer's disease: Double blind placebo-controlled study

UMIN ID: UMIN000007734

Registered date:16/04/2012

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Alzheimer's disease
• Date of first enrollment: 2012/04/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Actural drug group 1)To take 200mg (4capsules) rosmarinic acid per day for 2 weeks after the start of the test. 2)To take 400mg (8capsules) rosmarinic acid per day for 2nd-4th weeks. 3)To take 500mg (10capsules) rosmarinic acid per day for 4th-48th weeks. 4)To stop rosmarinic acid administration at 48th week of the test.
Placebo group 1)To take placebo (4capsules) per day for 2 weeks after the start of the test. 2)To take placebo (8capsules) per day for 2nd-4th weeks. 3)To take placebo (10capsules) per day for 4th-24th weeks. 4)To stop placebo administration and start rosmarinic acid intake at 24th week of the test. 5)To take 200mg (4capsules) rosmarinic acid and placebo (6capsules) per day for 24th-26th weeks. 6)To take 400mg (8capsules) rosmarinic acid and placebo (2capsules) per day for 26th-28th weeks. 7)To take 500mg (10capsules) rosmarinic acid per day for 28th-48th weeks. 8)To stop rosmarinic acid administration at 48th week of the test.

Outcome(s)

• Primary Outcome: To evaluate safety and tolerability of long-term intake of rosmarinic acid. Including incidence of adverse event, physical examination, neurological examination, vital signs, laboratory examination and cognitive tests. The ratio of the patients who completed the course of rosmarinic acid intake (200mg-500mg per day) for 48 weeks.
• Secondary Outcome: To evaluate the changes of cognitive tests between screening and post-intake of rosmarinic acid. 1: Significant improvement, 2: Improvement, 3: No change, 4: Slight deterioration, 5: Deterioration, 6: Can not be determined. To evaluate the changes of PIB-PET, FDG-PET, cerebrospinal fluid biomarkers (Abeta1-42, total tau protein, phosphorylated tau protein) between screening and 24th week of the study.

Key inclusion & exclusion criteria

• Age minimum: 60years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Patients taken supplements which contain polyphenols within 1 month. 2.Patients with severe heart disease, liver disease, kidney disease. 3.Patients who has malignancy. 4.Patients who has previous history of alchol and/or drug abuse. 5.Patients who has hypersensitivity to polyphenols. 6.Patients who has drug and/or food allergy. 7.Patients participating in other clinical trials. 8.Patients newly administrated other dementia therapeutics within 60 days including Galantamine Hydromide (Reminyl, Takeda pharmaceutical company limited. Janssen pharmaceutica), Memantine Hydrochoride (Memary, DaiichiSankyo company limited), Rivastigmine (Exelon patch, Novartis/ Rivastach patch, Ono pharmaceutical company limited), Donepezil Hydrochloride (Aricept, Aricept D, Eisai). During this trial, addition and change of other dementia therapeutic drugs are not permitted in principle. 9.The patients judged to inadequacy by the attending physician or principal investigator.

Related Information

• Primary Sponsor: Kanazawa University Graduate School of Medical Science
• Secondary Sponsor: Takasaki University of Health and welfare Tokyo University Graduate School of Agricaltural and Life Sciences
• Source(s) of Monetary Support: Japan Society for the Promotion of Science,Maruzen Pharmacenticals company limited