Could a stroke drug help dementia patients?
NCT ID NCT03804229
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests whether butylphthalide soft capsules can improve thinking, memory, and daily living skills in people with mild to moderate vascular dementia. About 707 participants are randomly assigned to receive either the drug or a placebo for 52 weeks. The study aims to confirm earlier promising results from a Phase 2 trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Butylphthalide soft capsule
- What this could lead to
- If successful, this could provide a new treatment option to slow cognitive decline and improve daily function in people with vascular dementia.
- What could go wrong
- This is a Phase 3 trial, but results are not yet published. The drug may not show significant benefit over placebo, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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707 people
The number who actually took part.
- Started
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Oct 2019
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Age ≥50 and ≤75, male or female. * 2\. The subjects must have completed primary school education or above, and be able to complete the cognitive ability test and other tests required by the program. * 3\. Meet the vascular dementia diagnosis criteria specified in the Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-V). * 4\. Meet the SIVD diagnosis criteria of Erkinjuntti. * 5\. MRI supports the existence of an ischemic cerebrovascular disease; Meet the National Institute of Neurological Disorders and Stroke (NINDS-AIREN) imaging diagnosis criteria; The lesion located between supra-tentorial and subcortical areas; The maximum diameter of the infarction ≤30mm; The number of infarctions ≥3, and/or Fazekas score=2-3. * 6\. The patients need to be enrolled 3 months after the last stroke, if there is a clear history of stroke; otherwise meet other Criteria. * 7.The subjects are suffering from mild or moderate vascular dementia, with 11≤ MMSE ≤26, and the Clinical Dementia Rating (CDR) score 1≤ CDR ≤2. * 8\. The Hamilton depression scale (HAMD) total score ≤17. * 9\. The patient agrees to participate in this study and the patient or his or her legal guardian has signed the informed consent before the study. * 10\. The subjects must have a care giver who has completed primary school education or above. The MMSE score of the care giver should be within the following range: education level of primary school \> 20 points, education level above primary school \> 24 points. And the care giver shall also be able to take care of the patient at least 4 days a week for more than 4 hours a day while he or she can accompany the subjects to attend each visit. Exclusion Criteria: * 1\. Patients suffering from dementia caused by other cerebral diseases other than VaD (such as Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease, demyelinating diseases of the central nervous system, tumors, hydrocephalus, traumas, syphilis, AIDS, Creutzfeldt-Jakob disease, etc.); * 2\. MRI indicates hippocampus or entorhinal cortex atrophy; and patients for whom VaD in combination with AD has been maximally excluded. But the following two cases can be included: ① Those aged 70 years and above with MTA score of grade 2 can be included; ② Those with grade 3 white matter injury score can be included with MTA score of grade 2. * 3\. Patients with severe neurologic impairments that hinder them from completing the required tests, such as hemiplegia of the convenient hand, various kinds of aphasia, and audio or visual disorders. * 4\. Patients who cannot swallow any orally administered drugs, or who is suffering from any disease that can affect the absorption of orally administered drugs, such as active intestinal diseases, partial or complete intestinal obstruction. * 5\. Patients suffering from severe diseases of the circulation system, the respiration system, the urinary system, the digestive system and the hemopoietic system (such as unstable angina pectoris, uncontrollable asthma and active gastric bleeding) and cancer. * 6\. Patients suffering from nutritional and metabolic diseases and endocrine system disorders, such as thyroid disease, parathyroid disease and deficiency of vitamin or other elements. * 7\. Patients suffering from severe mental diseases (such as depression and schizophrenia) and epilepsy. * 8\. Patients with alcohol or drug abuse. * 9\. Patients with a family history of dementia. * 10\. Patients who have been given any drug that can affect the cognitive function, such as cholinergic drugs, antipsychotic drugs and nootropic agents (including traditional Chinese herbal medicines and pills, such as cholinesterase inhibitors, memantine, Cenma Yizhi Capsules and Jiannaoan), for a long period of time (within 3 month before the start of this study and will continue using such drug). * 11\. Patients who have used Butylphthalide soft capsule or injection within 2 weeks before grouping. * 12\. Patients who are allergic to Butylphthalide/celery. * 13\. Patients with severe bleeding tendency or hepatic dysfunction (with transaminase higher than 3 times of the normal upper limit). * 14\. Pregnant or breast feeding women. * 15\. Patients who have participated in other interference clinical studies within 3 months before grouping. * 16\. Patients for whom MRI cranial imaging cannot be performed.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053, China
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Other studies related to the condition(s) this trial covers.
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