Edaravone dexborneol tablets for cognitive impairment after stroke

Efficacy and Safety of Edaravone Dexborneol Sublingual Tablet for Post-stroke Cognitive Impairment in Patients With Acute Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled, Exploratory Phase II Clinical Trial.

This study is testing if a new tablet can help improve thinking and memory in people who have had a stroke.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Simcere Pharmaceutical Co., Ltd (Academic / other)
• Drugs / interventions: Lecanemab, Donanemab, Aducanumab
• Locations: 21 sites (Fuyang, Anhui and 20 other locations)
• Trial ID: NCT06315231 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of edaravone dexborneol sublingual tablets in patients experiencing post-stroke cognitive impairment following an acute ischemic stroke. It is a multicenter, randomized, double-blind, placebo-controlled Phase II trial, where participants will receive either the active treatment or a placebo for 24 weeks. The study aims to compare the cognitive outcomes and safety profiles between the two groups to determine the potential benefits of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 80 who have experienced an ischemic stroke and exhibit mild cognitive impairment.

Not a fit: Patients with significant pre-stroke functional disabilities or severe cognitive dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve cognitive function in patients recovering from an ischemic stroke.

How similar studies have performed: While this approach is exploratory, similar studies targeting cognitive impairment post-stroke have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 40 years and ≤ 80 years, male or female.
2. Diagnosed as ischemic stroke, no significant pre-stroke functional disability (mRS score ≤ 1prior to stroke onset).
3. The National Institutes of Stroke Scale score ≤ 20 points.
4. Time from onset to obtained informed consent form is within 7 days (including 7 days).
5. Presence of cognitive dysfunction at screening, i.e., MoCA scale score \< 22.
6. Patients with good cognitive function prior to stroke, without significant cognitive dysfunction and dementia.
7. Education level: primary school or above, and can complete the cognitive function test required per investigator's judgement.
8. female subjects of childbearing potential and male subjects whose female partners are of childbearing potential must be willing to and use contraception during the study treatment and within 30 days after the last dose of study drug and have no plans to donate sperm or eggs; female subjects of childbearing potential will have a negative pregnancy test;
9. obtain voluntary signed informed consent from the patient or his/her legal representative approved by the Ethics Committee.

Exclusion Criteria:

1. Presence of intracranial hemorrhagic disease confirmed by brain imaging.
2. Severe disturbance of consciousness: NIHSS 1a level of consciousness item score \> 1 point.
3. Transient ischemic attack (TIA).
4. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control.
5. Poorly controlled diabetes (fasting blood glucose \>10mmol/L and/or HbA1c\>8%).
6. Patients with contraindications to MRI imaging.
7. For subjects who are scheduled to undergo EEG examination, Patients with contraindications for EEG examination.
8. Presence of cognitive dysfunction prior to stroke assessed by informants, that is, the average score of Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE, 16-item version) during the screening period was ≥ 3.19 and the total score was ≥ 51.
9. Patients who have been diagnosed with severe mental disorders prior to stroke.
10. Severe limb hemiplegia and aphasia and significantly affect cognitive function assessment.
11. Patients have received the cognitive enhancers and other anti-dementia drugs within 1 month before the screening period, including but not limited to cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and non-competitive N-methyl-D-aspartate (NMDA) receptor antagonists (memantine) and other drugs (such as mannitol sodium capsules, Ginkgo Biloba Extract Injection, Compound Ginkgo Biloba Tablets, oxiracetam, aniracetam, piracetam，nicergoline, Lecanemab, Donanemab, Aducanumab, etc. ).
12. Have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT or AST \> 2.0 × ULN.
13. Has been diagnosed with severe active kidney disease, renal insufficiency; or serum creatinine \> 1.5 × ULN.
14. Thrombectomy or interventional therapy has been applied or planned after this episode.
15. History of malignancy; except for subjects with non-melanoma skin cancer (NMSC) that has been successfully treated and limited cervical cancer in situ. Subjects with a diagnosis of malignancy after enrollment may continue to participate in the study or not at the discretion of the investigator and at the discretion of the subject;
16. Suffering from a severe systemic disease with an expected survival period of \<1 year;
17. hypersensitivity to dextran camphene, natural ice chips or edaravone or excipients (mannitol, copovidone, microcrystalline cellulose, cross-linked povidone, silicon dioxide, magnesium stearate);
18. pregnancy, lactation, and patients planning pregnancy;
19. history of major surgery within 4 weeks prior to enrollment;
20. participation in another clinical study within 30 days prior to randomization, or ongoing participation in another clinical study;
21. in the opinion of the investigator, not suitable for participation in this clinical study.

Where this trial is running

Fuyang, Anhui and 20 other locations

• Taihe County People's Hospital — Fuyang, Anhui, China (Recruiting)
• Hefei First People's Hospital — Hefei, Anhui, China (Recruiting)
• The First Affiliated Hospital of USTC Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)
• The Second People's Hospital of Hefei — Hefei, Anhui, China (Recruiting)
• Huangshan City People's Hospital — Huangshan City, Anhui, China (Recruiting)
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
• Wuzhou Red Cross Hospital — Wuzhou, Guangxi, China (Recruiting)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• Zhumadian Central Hospital — Zhumadian, Henan, China (Recruiting)
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Liaoning Health Industry Group Bensteel General Hospital — Benxi, Liaoning, China (Recruiting)
• The First Hospital of Dalian Medical University — Dalian, Liaoning, China (Recruiting)
• The First People's Hospital of Shenyang — Shenyang, Liaoning, China (Recruiting)
• Affiliated Hospital of Jining Medical College — Jining, Shandong, China (Recruiting)
• Liaocheng People's Hospital — Liaocheng, Shandong, China (Recruiting)
• Tai'an Central Hospital — Taian, Shandong, China (Recruiting)
• Suining Central Hospital — Suining, Sichuan, China (Recruiting)
• Dongyang People's Hospital — Dongyang, Zhejiang, China (Recruiting)
• The First People's Hospital of Huzhou — Huzhou, Zhejiang, China (Recruiting)
• Zhuji People's Hospital of Zhejiang Province — Zhuji, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Chunchen Huang, Doctor

Conditions Post-stroke Cognitive Impairment