The effect of betahistine mesylate on cognitive function for patients with peripheral vestibular dysfunction.

JRCT ID: jRCT1031210699

Registered date:26/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Peripheral Vestibular Dysfunction
• Date of first enrollment: 26/03/2022
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Patients who meet the selection criteria will be randomized and classified into (1) betahistine mesylate-administered group and (2) non-administered group.
Patients in group (1) receive betahistine mesylate 36 mg / day for 12 weeks in addition to standard treatment. Group (2) receives only standard treatment.

Outcome(s)

• Primary Outcome: Differences in Benton Visual Retention Test (BVRT) scores before and 12 weeks after the start of treatment between the betahistine mesylate-treated group and the non-treated group.
• Secondary Outcome: Differences in Mini Mental State Examination score, Trail Making Test score, and VSRAD Z score before and 12 weeks after the start of treatment between the betahistine mesylate-treated group and the non-treated group.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients diagnosed with vertigo at department of Otorhinolaryngology, Showa University Fujigaoka Hospital.
2) Patients diagnosed with mild cognitive impairment or suspected dementia , and MMSE score is 26 points or less.
3) Patients aged 20 years or older at the time of obtaining consent.
4) Patients who consented to participate in this study.

Exclude criteria

1) Patients who are contraindicated for the administration of betahistine mesylate.
2) Patients who have taken betahistine mesylate within the past month from the first visit.
3) Patients with MMSE score of 21 points or less and suspected dementia who meet the dementia diagnostic criteria (DSM-5 (2013)) and should prioritize their treatment.
4) Patients with malignant tumors.
5) Patients suffering from severe liver dysfunction, renal dysfunction, or heart disease that affect drug safety assessment.
6) Patients with a history of cerebrovascular accident.
7) Patients judged by the investigator to be ineligible for research.

Related Information

• Primary Sponsor: Kobayashi Sei