Clemastine Fumarate for Alcohol Use Disorder

Clemastine Fumarate for Cognitive Impairment in Alcohol Use Disorder : A Proof of Concept Study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041220020

Enrollment

Registered

2022-05-25

Start date

2022-06-20

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

alcohol dependence or alcohol use disorder Alcohol use disorder

Interventions

Clemastine Fumarate administered orally between Day1 and Day90, 1mg twice a day.

D002974

Clemastine Fumarate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients over 20 years old. (2) Patients for whom consent can be obtained. (3) Patients with outpatients status. (4) Patients diagnosed with alcohol dependence or alcohol use disorder based on ICD-11 or DSM-5 criteria. (5) Patients with Mini-Mental State Exam score of 22 points or higher. (6) Patients who have maintained total abstinence or who have reduced their alcohol consumption (based on the Japan treatment guideline.https://www.j-arukanren.com/pdf/20190104_shin_al_yakubutsu_guide_tebiki.pdf) (7) Patients who have been abstinent or reduction of alcohol consumption for at least 1 month but 5 years or less since consent was obtained.

Exclusion criteria

Exclusion criteria: (1) Patient with cognitive impairment or intellectual disability due to other than alcohol use disorder. (2) Patient with pregnant, lactating or planning pregnancy. (3) Patients who engaged in operating hazardous machinery. (4) Patients with hypersensitivity to clemastine fumarate. (5) Patients with angle closure glaucoma or open angle glaucoma. (6) Patients with obstructive disorders in the lower urinary tract. (7) Patients with stenotic gastrointestinal ulceration or pyloric duodenal obstruction. (8) Patients with convulsive disorder. (9) Patients with AST, ALT, ALP, LDH or gamma-GTP >= 2.5 xULN. (10) Patients who deemed ineligible as determined by the principal investigator or a co-investigator.

Design outcomes

Primary

Measure	Time frame
(1) All-cause discontinuation rate	—

Secondary

Measure	Time frame
(1) Change MMSE score from baseline to endpoint (2) Change AUDIT score from baseline to endpoint (3) Change ARRS score from baseline to endpoint (4) Discontinuation rate due to adverse events Incidence of individual adverse events.	—

Contacts

Public ContactTaro Kishi

Fujita Health University Hospital

tarok@fujita-hu.ac.jp+81-562-93-9250

Outcome results

None listed

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