NIPH Clinical Trials Search

Study on the efficacy of Balenine in preventing cognitive decline

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	dementia
Date of first enrollment	14/10/2025
Target sample size	40
Countries of recruitment	nome,Japan
Study type	Interventional
Intervention(s)	Take one capsule containing Balenine (500 mg) or placebo once a day after a meal (for approximately 12 weeks)

Outcome(s)

Primary Outcome	Change in MMSE
Secondary Outcome	safety MMSE responder rate MoCA-J responder rate and change Cogstate Brief Battery Patient's global impression

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	(1) Dementia and regular medical visits possible. (2) Mini-mental state examination (MMSE) score of 21 or more. (3) Age 18 or older at the time of consent. (4) The subject or a legal representative must give written consent to participate in the study.
Exclude criteria	(1) Patients who do not meet the eligibility criteria (2) Patients who are judged by the principal investigator or co-investigator to be inappropriate for participation in this study