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

A no treatment-controlled, single-center, randomized, parallel-group clinical trial , the effect of betahistine mesylate on cognitive function for patients with peripheral vestibular dysfunction.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031210699
Enrollment
100
Registered
2022-03-26
Start date
2022-03-26
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

Peripheral Vestibular Dysfunction

Interventions

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 me

Sponsors

Kobayashi Sei
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactHiroyuki Hibi

Showa University Fujigaoka Hospital

eyokoa87@med.showa-u.ac.jp+81-459711151

Outcome results

None listed

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