Evaluation of efficacy of yokukansan in patients with dementia with Lewy bodies using NPI-D as an indicator.

UMIN ID: UMIN000001832

Registered date:01/04/2009

Basic Information

• Health condition(s) or Problem(s) studied: Dementia with Lewy bodies
• Date of first enrollment: 2009/04/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Normal adult dosage is 7.5 g/day divided into 2 to 3 oral doses, and taken before or between meals. Dosage may be adjusted according to the patient's age, weight and symptoms. Administration period: 8 weeks

Outcome(s)

• Primary Outcome: NPI-D (administered at weeks 8 after the start of treatment)
• Secondary Outcome: MMSE, Barthel Index, cerebral blood flow (administered at week 8 after the start of treatment)

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients with malignancy, severe disease of heart, liver, renal, blood, lung and other life-threatening diseases 2) Patients who fail to meet the DSM-IV diagnostic criteria for our study, but show symptoms of BPSD due to other concomitant neurodegenerative disease, schizophrenia, bipolar disorder, major depression or other psychiatric disorders 3) Patients with delirium due to alcohol or drug addictions, metabolic poisoning, or inflammatory disease 4) Patients who are unable to take oral medications 5) Patients initiated the therapy with donepezil hydrochloride or made change in dosage and administration of the drug within 8 weeks before the start of treatment 6) Patients received drugs prohibited for concomitant use or drugs restricted in concomitant use during wash-out period, 7) Patients who took long acting antipsychotic drugs (such as haloperidol decanoate) within 4 weeks before the start of treatment 8) Patients who are determined as unfit for the study by attending physicians for reasons other than those stated above

Related Information

• Primary Sponsor: Department of Geriatric Medicine, Kyorin University School of Medicine
• Source(s) of Monetary Support: none