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Treatment outcome and quality of life in patients with permanent post-stroke non-fluent aphasia treated by donepezil: A randomized clinical study

Treatment outcome and quality of life in patients with permanent post-stroke non-fluent aphasia treated by donepezil: A randomized clinical study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251117014
Enrollment
50
Registered
2025-11-17
Start date
2026-02-17
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Permanent Post-stroke non-fluent aphasia Post-stroke non-fluent aphasia Donepezil Thai adaptation of Western Aphasia Battery

Interventions

Taking donepezil 2.5 mg for 4 weeks then then increasing the dosage to 5 mg for the subsequent 12 weeks,Taking placebo for 16 weeks (placebo will be adjusted to look similar to the intervention group
Experimental Drug,Placebo Comparator Drug
Donepezil,Placebo

Sponsors

Ratchadapiseksomphot Research Funds Type II
Lead Sponsor
Grants for development of new faculty staff, Ratchadaphiseksomphot fund, Chulalongkorn University,Berlin Pharmaceutical Industry Co., Ltd.
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Non-fluent aphasia due to ischemic stroke for more than 1 year despite speech rehabilitation program, confirm by Thai adaptation of Western Aphasia Battery

Exclusion criteria

Exclusion criteria: 1. Severe language comprehension difficulties, 2. Speech problems not due to language disorders such as severe spastic dysarthria, akinetic mutism or severe depression, 3. Currently receiving treatment with acetylcholinesterase inhibitor, 4. Precautions for donepezil administration such as bradycardia, hypotension, seizure, etc., 5. Unable to perform brain MRI.

Design outcomes

Primary

MeasureTime frame
Severity of aphasia Before and after the intervention Scores and subscores of the Thai adaptation of Western Aphasia Battery

Secondary

MeasureTime frame
Communication abilities Before and after the intervention Communicative Activity Log,Brain structure and connectivity Before and after the intervention Brain MRI (T1, T2-FLAIR, DTI, resting state fMRI),Side effect Along the intervention period Questionaire

Countries

Thailand

Contacts

Public ContactThachamai Smitasiri

Faculty of Medicine, Chulalongkorn University

thachamai.s@chula.ac.th66968804849

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026