The efficacy and safety of Yokukansan for BPSD in Alzheimer's disease. a randomized, double-blind, placebo-control trial.

The efficacy and safety of Yokukansan for BPSD in Alzheimer's disease. a randomized, double-blind, placebo-control trial. - The efficacy and safety of Yokukansan for BPSD in Alzheimer's disease.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004325

Enrollment

140

Registered

2011-02-01

Start date

2011-02-01

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

Alzheimer&#39

Interventions

TSUMURA Yokukansan Extract Granules (active drug) TSUMURA Yokukansan Extract Granules (placebo)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with mild to moderate Alzheimer's disease. 2)BPSD is present on NPI-Q-J. 3)Serum potassium level should be in normal range. 4)have a study partner able to provide an independent evaluation of functioning. 5) Agreement to sign an informed consent

Exclusion criteria

Exclusion criteria: 1)Patients with non-Alzheimer's dementia 2)No lesion exists in brain MRI. 3)Presence of severe illness 4)Those who have used Yokukansan ever before 5)Those who have joined any clinical trial within 3 month 6)Those who are thought inadequate by their doctor.

Design outcomes

Primary

Measure	Time frame
Neuropsychiatric Inventory-Q-J(NPI-Q-J)	—

Secondary

Measure	Time frame
Mini-Mental-State-Examination-J (MMSE-J)	—

Countries

Japan

Outcome results

None listed

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

The efficacy and safety of Yokukansan for BPSD in Alzheimer&#39;s disease. a randomized, double-blind, placebo-control trial.