Brain training and new drug combo tested to fight memory loss in stroke risk patients
NCT ID NCT07605130
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This study tests whether a tablet-based brain training program and/or a powerful cholesterol-lowering drug (PCSK9 inhibitor) can improve thinking and memory in 420 adults aged 55-80 with narrowed brain arteries. Participants will be split into four groups, combining or not combining the training with standard or intensive cholesterol treatment. The main goal is to see if these approaches boost cognitive scores after 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Recaticimab (PCSK9 inhibitor) injection, plus statins and ezetimibe
- What this could lead to
- If successful, this could point toward a way to slow or improve cognitive decline in people with intracranial atherosclerosis.
- What could go wrong
- This is a Phase 4 trial with 420 participants, so results are not yet known. The cognitive training is intensive (30 min/day, 5 days/week), and the added drug may cause side effects like injection site reactions or muscle pain.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 440 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
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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55 to 80 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 55-80 years old 2. The number of years of education is greater than or equal to 6 years 3. 50%-99% stenosis of the intracranial artery confirmed by MRA, CTA or DSA 4. Head CT or MRI confirmed that there were no infarct lesions/softening foci larger than 3 cm in the brain 5. LDL-C ≥ 1.8mmol/L at baseline 6. Decline in cognitive function of the complainant 7. MMSE ≥ 24 points; no severe impairment of daily living and social functioning, and the daily living ability scale (ADL, 14-item BADL and IADL combined version, total score range of 14-56 points) \<=18; and the investigator's clinical assessment does not meet the diagnosis of dementia (DSM-V or NIA-AA diagnostic criteria) 8. Proficient in operating electronic products such as mobile phones and tablets 9. Complete the operation evaluation through the introduction period (see the definition of the introduction period) 10. Agree to receive moderate-intensity statin and PCSK9 inhibitor therapy during the study period 11. Able to cooperate with neuropsychological and multimodal magnetic resonance examinations Exclusion Criteria: 1. Extracranial cervical artery stenosis ≥ 50% 2. Acute cerebrovascular events within 90 days 3. Contraindications to MRI (metal implants in the body, claustrophobia, etc.) 4. Visual and auditory impairments, as well as communication difficulties, that affect cognitive training 5. Clinically diagnosed vascular dementia 6. Neuroimaging showing significant white matter lesions (Fazekas grade 3) or multiple microbleeds 7. Non-atherosclerotic intracranial artery stenosis (such as vasculitis, moyamoya disease, dissection, etc.) 8. Neurodegenerative diseases (Alzheimer's disease, Parkinson's disease, etc.) 9. Severe comorbidities (tumors, multiple sclerosis, severe cardiopulmonary and renal diseases, intracranial aneurysms) 10. Other diseases that may affect cognition have been ruled out; severe anxiety, depression, or schizophrenia; a new stroke occurring within the 3 months prior to baseline; hereditary or inflammatory small vessel diseases; presence of any of the following clear sources of cardioembolic events: mitral stenosis, mechanical heart valves, endocarditis, intracardiac clots or vegetations, dilated cardiomyopathy, chronic or paroxysmal atrial fibrillation, ejection fraction less than 30% 11. Planning to use medications that may affect cognitive function within the past 3 months or in the following 24 weeks, including large amounts of sedatives, anti-anxiety drugs, cognitive enhancers, and cholinergic agents.(12) Previously treated with a PCSK9 inhibitor 12. Having a clear contraindication or severe intolerance to PCSK9 inhibitors or statins (such as a history of severe allergic reactions) 13. Presence of significant liver or muscle safety abnormalities at baseline, or the investigator deems the patient unsuitable for intensive lipid-lowering therapy (for example, significantly elevated ALT or AST, significantly elevated CK, etc.; the thresholds can be based on the reference ranges of each center's laboratory and specified in the protocol in advance) 14. Other circumstances deemed inappropriate for enrollment by the investigator
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
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