New Alzheimer's drug trial uses eye scans to track brain changes
NCT ID NCT07604896
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called lecanemab in 200 people with early-stage Alzheimer's. Participants receive either lecanemab or standard care for 24 months. Researchers use eye and brain scans along with memory tests to see if the drug slows the disease and to check for side effects like brain swelling.
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 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2028
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 90 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: * Age: 50 to 90 years old. * No gender restrictions. * Patients with MCI and mild AD. * The MMSE score is ≥20, and the overall CDR score is 0.5 or 1 point. * Positive Amyloid protein confirmed by amyloid-PET or CSF. * There is a reliable caregiver accompanying the patient during the research visit and supervising the use of the study drug during the trial. * Agree to participate in the research and sign the informed consent form. Exclusion Criteria: * Patients with cognitive impairment caused by reasons other than AD. * There was a history of transient ischemic attack (TIA), stroke, cerebral hemorrhage or epileptic seizure within 12 months prior to screening. * A Hamilton Depression Scale score of more than 17 at the time of screening, or any suicidal behavior within 6 months before screening, during screening, or at baseline visits, as well as other psychiatric diagnoses or symptoms (such as hallucinations, anxiety disorders, or delusions) that interfere with the research process of the subjects. * Patients with hemorrhagic diseases or those receiving anticoagulant therapy, as well as any patients with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine and cardiovascular system diseases that affect this study. * There is a hypersensitivity reaction to lecanemumab or any other component in the injection solution or any monoclonal antibody treatment. * There are contraindications for MRI scans, including the installation of cardiac pacemakers/defibrillators and ferromagnetic metal implants (except for cranial and cardiac devices approved for safe use in MRI scans). * There is a known or suspected history of drug or alcohol abuse or dependence within two years prior to screening. * Subjects who participated in clinical studies involving any therapeutic monoclonal antibodies or novel compounds for the treatment of AD within 6 months prior to screening, unless it can be demonstrated that the subjects were in the placebo treatment group. * Surgical operations under general anesthesia are planned to be performed during the research period. * Women who have positive pregnancy test results, are breastfeeding or pregnant at the time of screening or baseline.
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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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First Affiliated Hospital of Wenzhou Medical University
RECRUITINGWenzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 10-Year watch: how safe is lecanemab outside clinical trials?
- Can a Melatonin-Like pill slow Alzheimer's memory loss?
- Could brain stimulation help Alzheimer's patients think more clearly?
- Could a common blood pressure pill recharge brain cells in Alzheimer's?