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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001897
Enrollment
20
Registered
2009-04-20
Start date
2009-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fronto-Temporal Lobar Degeneration (FTLD)

Interventions

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&#39
s age, weight and symptoms. Administration period : 8 weeks

Sponsors

Ehime University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patientsw diagnosed with Fronto-Temporal Dementia (FTD) or Semantic Dementia (SD) according to the clinical criteria of Intrenational Working Group(Neary D. et al, 1998) of Fronto-Temporal Lober Degeneration. 2) Patients with NPI-D score of 4 and hugher in 1 or more items at the start f the treatment. 3) Patients with serum potassium levels within the standard range of the facility when measured within 8 weeks before the start of teatment. 4) Medical Consultation : Outpatients as a general ule, but inpatients from hospitals, clinics and medical facilities are also accepted (changes in medical setting where patients receive care during the study, however, is unacceptable). 5) Outpatients must have a reliable caregiver at home during the entire duration of the study who can tranport the patient to the hospital for conculusion. 6)Inpatients must have been receiving care at their respective medical facility for least 2 weeks before the strart of the study, and must also have a caregiver or belong to a nursing home during the entire dution of the study.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
NPI-D

Secondary

MeasureTime frame
SRI, Barthel Index, Zaril Caregiver Burden Scale MMSE, swallowing ability, appetite level, questionnaire regarding eating patterns, cerebral blood flow

Countries

Japan

Contacts

Public ContactSatoshi TANIMUKAI

Ehime University Graduate School of Medicine Department of Neuropsychiatry, Neuroscience

satanimu@m.ehime-u.ac.jp089-960-5315

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026