Efficacy and Safety of Conventional Symptomatic Drugs Combined with Lencanizumab in the Treatment of Early Alzheimer's Disease: a Multicenter, Prospective, Observational Study

Launched by FIRST HOSPITAL OF CHINA MEDICAL UNIVERSITY · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a new treatment called lencanizumab, used alongside standard medications for people with early Alzheimer's disease (AD) and mild cognitive impairment related to AD. The aim is to see how this combination can help slow down the progression of the disease and improve patients' cognitive functions. With the growing number of older adults facing cognitive challenges, this study is important in finding better ways to manage early-stage Alzheimer's.

To participate in the trial, individuals must be between 50 and 85 years old, have a confirmed diagnosis of early Alzheimer's or mild cognitive impairment, and have specific amyloid deposits in the brain as shown by medical tests. Participants will undergo assessments like MRI scans and cognitive tests over 18 months to monitor their progress. It's crucial for potential participants and their families to understand that this study seeks to gather real-world evidence on how well this treatment works and how it affects daily life for patients and their caregivers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged 50 and 85 years old, male or female;
• • 2. The subjects had primary school education (education) or above, normal hearing, vision and pronunciation, native tongue is Chinese, and daily language is Mandarin, and were able to complete the information collection stipulated in the program.
• • 3. The AD diagnosis met the diagnostic criteria for dementia described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R), using the 2011 NIA-AA AD diagnostic criteria. The MCI diagnosis met the MCI diagnostic criteria of Peterson in 2004;
• • 4. The presence of amyloid deposits was confirmed by biomarkers: imaging or cerebrospinal fluid biomarkers.
• • 5. Having cognitive decline, having one of the following conditions: (a) MMSE score of 20 or above; (b) CDR-GS score of 0.5 or 1;
• • 6. The combination group met the criteria for cainumab (according to cainumab instructions);
• • 7. Willing and able to complete all the requirements of the study (including MRI, neuropsychological assessment, clinical genotyping, etc.);
• • 8. Established caregivers or family members can objectively conduct CDR, quality of life scale, daily life performance scale and other clinical assessments;
• • 9. The patient and their family members were informed and signed the informed consent form.
• Exclusion Criteria:
• • 1. There are other neurological diseases that can cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal skull pressure hydrocephalus, etc.);
• • 2. There are other systemic diseases that can cause cognitive impairment (such as liver insufficiency, renal insufficiency, thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
• • 3. Presence of serious or unstable diseases, including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological (except AD), psychiatric, immune, or hematological diseases and other diseases that the investigator believes may affect the results of the study analysis, or a life expectancy of \<24 months;
• • 4. History of schizophrenia, schiztive disorder, major depression or bipolar disorder, and history of major depression may be enrolled in the study if no episodes occurred or mitigated or controlled in the past year; risk of suicide; a history of alcoholism and / or substance abuse or dependence in the past 2 years (according to the Diagnostic and Statistical Manual of Mental Disorders, Version 5th standard)
• • 5. Severe stroke sequelae (mRS\> 3 or previous stroke history);
• • 6. Clinically significant systemic immune participants due to the sustained effects of immunosuppressive drugs;
• • 7. Failure to tolerate MRI tests or with MRI contraindications, including but not limited to: a pacemaker incompatible with MRI, eye, skin, MRI clips, artificial heart valve, ear implant, or external metal implant, or other clinical history or findings of which MRI may cause potential harm;
• • 8. Subjects with a history of allergy to any treatment component such as cincainizumab;
• • 9. Refusal to sign the informed consent form.