The safety and efficacy of Yokukansan in treating neuropsychiatric symptoms of patients with Fronto-Temporal Lobar Degeneration (FTLD)

UMIN ID: UMIN000001897

Registered date:20/04/2009

Basic Information

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

Outcome(s)

• Primary Outcome: NPI-D
• Secondary Outcome: SRI, Barthel Index, Zaril Caregiver Burden Scale MMSE, swallowing ability, appetite level, questionnaire regarding eating patterns, cerebral blood flow

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients with concomitant diagnosis of malignant cancer. 2) Patients with concomitant diagnosis o sevious heart, liver, lung or kidney disease, blood disorders, or other life-threatening diseases. 3) Ptients with other forms of dementia (AD, VD, DLB) besides Fronto-Temporal Degeneration (FTLD) 4) Patients who fail to meet the DSM-IV diagnostic criteria for our study, but show symptoms of BPSD due to other concomitant neurodegerative disease, Scizophrenia, Bipolar disorder, Major depressive disorder or other psychiatric disorders. 5) Patients with delirium due to alcohol or drug addicution, metabolic poisoning, or inflammatory disease. 6) Patients who are unable to take oral medications. 7) Patients who altered their dosage or method of administration of SSRI, 8 weeks before the start of the study. 8) Ptients who took long acting antipsychotic durgs (such as haloperidol decanoate) 4 weeks before the start of treatment. 9) Patients who are determined as unfit for the study by attending physicians for reasons other than those stated above.

Related Information

• Primary Sponsor: Ehime University Graduate School of Medicine
• Source(s) of Monetary Support: Tsumura Co. Ltd.