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Tests treatment safety and results for Alzheimer s Disease
Official title Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs
ClinicalTrials.gov ID: NCT07604896
What this study is testing
What is Lecanemab 10 mg/kg?
Lecanemab 10 mg/kg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for alzheimer s disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research proposal outlines a multi-center, randomized, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited.
- Phase 4: studies an already-approved treatment
- Time commitment: about 24 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 90
You may be able to join if
- 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.
You likely can't join if
- 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...
- Patients with hemorrhagic diseases or those receiving anticoagulant therapy, as well as any patients with malignant tumors, severe gastrointestinal...
- 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...
See the full eligibility 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.
- 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...
- 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...
- 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.
- people 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 people...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wenzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.