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Brain training and new drug combo tested to fight memory loss in stroke risk patients

NCT ID NCT07605130

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 440 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

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

55 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

Cognitive Dysfunction intracranial arteriosclerosis

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

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