Alzheimer's DiseaseNCT06868030
Efficacy and Safety of Conventional Symptomatic Drugs Combined with Lencanizumab in the Treatment of Early Alzheimer's Disease: a Multicenter, Prospective, Observational Study
An observational study of Alzheimer's Disease and MCI-AD, Early Stage Alzheimer's Disease, run by First Hospital of China Medical University.
Trial summary
According to the World Health Organization, China will become the "oldest" country in the world by 2050, with 35 percent of the elderly population. At present, in the Chinese population of 60 years old, there are about 15.07 million dementia patients (about 6.0%), about 9.83 million Alzheimer's disease (AD) patients… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease, MCI-AD, Early Stage Alzheimer's Disease
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2025 to June 2025, 120 patients with early AD (MCI-AD and mild AD) who met the inclusion and exclusion criteria and were confirmed to have amyloid protein deposition by biomarkers were selected from 10 centers. Among them, 60 patients were treated with lecanemab combined with symptomatic medication, and the other 60 patients were treated with conventional symptomatic medication.
Who may be able to join
- Patients aged 50 and 85 years old, male or female;
- 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.
- 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;
- The presence of amyloid deposits was confirmed by biomarkers: imaging or cerebrospinal fluid biomarkers.
- 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;
- The combination group met the criteria for cainumab (according to cainumab instructions);
Show all 9Show fewer
- Willing and able to complete all the requirements of the study (including MRI, neuropsychological assessment, clinical genotyping, etc.);
- Established caregivers or family members can objectively conduct CDR, quality of life scale, daily life performance scale and other clinical assessments;
- The patient and their family members were informed and signed the informed consent form.
Who cannot join
- 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.);
- 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.);
- 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;
- 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)
- Severe stroke sequelae (mRS> 3 or previous stroke history);
- Clinically significant systemic immune participants due to the sustained effects of immunosuppressive drugs;
Show all 9Show fewer
- 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;
- Subjects with a history of allergy to any treatment component such as cincainizumab;
- Refusal to sign the informed consent form.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
According to the World Health Organization, China will become the "oldest" country in the world by 2050, with 35 percent of the elderly population. At present, in the Chinese population of 60 years old, there are about 15.07 million dementia patients (about 6.0%), about 9.83 million Alzheimer's disease (AD) patients (about 3.9%), and about 38.77 million mild cognitive impairment (Mild cognitive impairment, MCI) patients (about 15.5%). A sharp increase in older people with cognitive impairment will bring a heavy disease burden, and the social cost is almost the sum of cancer, heart disease and stroke.
AD is an age-related neurodegenerative disorder characterized by a progressive decline in cognitive function and daily living capacity. The amyloid hypothesis of AD suggests that the deposition of A β is an early and inevitable event in AD pathogenesis. This hypothesis suggests that therapies that slow the deposition of A β plaques in the brain or increase the clearance of A β may slow the progression of the AD clinical syndrome. Most of the disease course of patients with cognitive impairment is more than 10 years long. How to diagnose and treat them in the early stage has become a key link to delay the progression of the disease and reduce the burden. The disease progression of AD is divided into three major stages: preclinical AD (Preclinical AD, Pre-AD), AD-derived mild cognitive impairment (Mild cognitive impairment due to AD, MCI-AD) and AD dementia (which can be subdivided into mild, moderate and severe AD). Among them, MCI-AD and mild AD are collectively known as early AD, which are the earliest clinical symptoms and the best window for identification and intervention. Studies show that about 43.4% of patients with MCI-AD will progress to AD dementia within 4 years, and 80% will progress within 6 years. If the disease advances to moderate or severe AD, patients will develop severe cognitive, functional impairment and behavioral symptoms, which interfere with social function and need help from daily living activities; severe or even complete loss of independence, requiring round-the-clock care. If early diagnosis and effective interventions in the early stages of the disease, it will help delay the disease into the moderate and severe stages, prolong the quality of life of patients, and greatly reduce the social burden of care and treatment.
Read more
At present, the treatment of AD is mainly symptomatic treatment, mainly including cholinesterase inhibitors and NMDA receptor antagonists. Phase-phase clinical trials show that luncinelizumab has a positive impact on cognitive function and pathological indicators in patients with early AD, delaying the early AD disease process by up to 27% relative to placebo treatment. Lencanizumab, a disease-modifying therapy for early AD, has been approved by FDA and NMPA in China. With the wide clinical application, the clinical efficacy and safety of lencanizumab combined with classical symptomatic therapy have attracted great attention. However, there are still few studies on the clinical characteristics, diagnosis and treatment patterns, efficacy and safety of the combination, and clinical outcomes of patients with early AD in the real world.
Based on this, this study intends to conduct an 18-month multi-center prospective real-world observational cohort study exploring the clinical characteristics, diagnosis and treatment patterns, efficacy and safety of the combination, caregiver and family burden of real-world early AD patients (MCI-AD and mild AD).
Read the detailed description
This study aims to establish a multicenter prospective real-world observational cohort study covering Northeast China, aiming to explore the clinical efficacy and safety of early AD patients combined with conventional drug therapy (luncainizumab combined with conventional drugs), describe the biomarkers and neuroimaging characteristics of early AD (MCI-AD and mild AD) patients in Northeast China; evaluate the cognitive function, daily living ability and neuropsychiatric symptoms of follow-up early AD patients for 18 months; Vertical investigation of family economic burden, caregiver burden, and medical resource utilization in early AD patients in northeast China. It further describes the clinical characteristics, diagnosis and treatment patterns, and the changes of related health outcomes in northeast China in the real world clinical diagnosis and treatment environment.
This study is an 18-month multicenter real-world observational cohort study of 120 early AD patients (MCI-AD and mild AD) attending at 6 centers from January to June 2025, completed the first annual visit from July to December 2025, the second annual visit from January to June 2026, and the third annual visit from July to December 2026.
- Keywords
- Alzheimer disease, MCI-AD, early stage Alzheimer's disease, lencanizumab, treatment
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Combination treatment group | no less than 60 early AD patients (MCI-AD and mild AD) were selected from 10 centers from January 2025 to June 2025. 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 criteria for AD. The MCI diagnosis met the MCI diagnostic criteria for the 2004 Peterson. | |
| Conventional symptomatic treatment group | no less than 60 early AD patients (MCI-AD and mild AD) were selected from 20 centers from January 2025 to June 2024. 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 criteria for AD. The MCI diagnosis met the MCI diagnostic criteria for the 2004 Peterson. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety of conventional symptomatic drugs combined with lencanizumab in the treatment of early Alzheimer's disease
Statistical difference in CDR and CDR-SB scores from baseline at 6,12 and 18 months, and in the incidence of adverse reaction events between the two groups.
Measured: After collecting the medical information of each follow-up period, the measurement and analysis results will be measured and analyzed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Huayan, First Hospital of China Medical University
- Investigators
- Huayan Liu, Study chair, the first affiliated hospital of China medical university, neurology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868030
- Sponsor's protocol ID
- LiuHuayan
- Status last verified
- Jan 2025
- First submitted
- 26 Jan 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Publications
van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29.
PubMed 36449413Porsteinsson AP, Isaacson RS, Knox S, Sabbagh MN, Rubino I. Diagnosis of Early Alzheimer's Disease: Clinical Practice in 2021. J Prev Alzheimers Dis. 2021;8(3):371-386. doi: 10.14283/jpad.2021.23.
PubMed 34101796Davis M, O Connell T, Johnson S, Cline S, Merikle E, Martenyi F, Simpson K. Estimating Alzheimer's Disease Progression Rates from Normal Cognition Through Mild Cognitive Impairment and Stages of Dementia. Curr Alzheimer Res. 2018;15(8):777-788. doi: 10.2174/1567205015666180119092427.
PubMed 29357799Cho SH, Woo S, Kim C, Kim HJ, Jang H, Kim BC, Kim SE, Kim SJ, Kim JP, Jung YH, Lockhart S, Ossenkoppele R, Landau S, Na DL, Weiner M, Kim S, Seo SW. Disease progression modelling from preclinical Alzheimer's disease (AD) to AD dementia. Sci Rep. 2021 Feb 18;11(1):4168. doi: 10.1038/s41598-021-83585-3.
PubMed 33603015Cohen S, Cummings J, Knox S, Potashman M, Harrison J. Clinical Trial Endpoints and Their Clinical Meaningfulness in Early Stages of Alzheimer's Disease. J Prev Alzheimers Dis. 2022;9(3):507-522. doi: 10.14283/jpad.2022.41.
PubMed 35841252王雪莹，李明，卢志明. 阿尔茨海默病生物标志物应用指南及研究进展. 中华预防医学杂志,2022,56(3):262-269.
Jia L, Du Y, Chu L, Zhang Z, Li F, Lyu D, Li Y, Li Y, Zhu M, Jiao H, Song Y, Shi Y, Zhang H, Gong M, Wei C, Tang Y, Fang B, Guo D, Wang F, Zhou A, Chu C, Zuo X, Yu Y, Yuan Q, Wang W, Li F, Shi S, Yang H, Zhou C, Liao Z, Lv Y, Li Y, Kan M, Zhao H, Wang S, Yang S, Li H, Liu Z, Wang Q, Qin W, Jia J; COAST Group. Prevalence, risk factors, and management of dementia and mild cognitive impairment in adults aged 60 years or older in China: a cross-sectional study. Lancet Public Health. 2020 Dec;5(12):e661-e671. doi: 10.1016/S2468-2667(20)30185-7.
PubMed 33271079
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Conventional Symptomatic Drugs Combined with Lencanizumab in the Treatment of Early Alzheimer's Disease: a Multicenter, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06868030
- Acronym / sponsor ID
- LiuHuayan
- Keywords
- Alzheimer disease, MCI-AD, early stage Alzheimer's disease, lencanizumab, treatment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to the World Health Organization, China will become the "oldest" country in the world by 2050, with 35 percent of the elderly population. At present, in the Chinese population of 60 years old, there are about 15.07 million dementia patients (about 6.0%), about 9.83 million Alzheimer's disease (AD) patients (about 3.9%), and about 38.77 million mild cognitive impairment (Mild cognitive impairment, MCI) patients (about 15.5%). A sharp increase in older people with cognitive impairment will bring a heavy disease burden, and the social cost is almost the sum of cancer, heart disease and stroke.
AD is an age-related neurodegenerative disorder characterized by a progressive decline in cognitive function and daily living capacity. The amyloid hypothesis of AD suggests that the deposition of A β is an early and inevitable event in AD pathogenesis. This hypothesis suggests that therapies that slow the deposition of A β plaques in the brain or increase the clearance of A β may slow the progression of the AD clinical syndrome. Most of the disease course of patients with cognitive impairment is more than 10 years long. How to diagnose and treat them in the early stage has become a key link to delay the progression of the disease and reduce the burden. The disease progression of AD is divided into three major stages: preclinical AD (Preclinical AD, Pre-AD), AD-derived mild cognitive impairment (Mild cognitive impairment due to AD, MCI-AD) and AD dementia (which can be subdivided into mild, moderate and severe AD). Among them, MCI-AD and mild AD are collectively known as early AD, which are the earliest clinical symptoms and the best window for identification and intervention. Studies show that about 43.4% of patients with MCI-AD will progress to AD dementia within 4 years, and 80% will progress within 6 years. If the disease advances to moderate or severe AD, patients will develop severe cognitive, functional impairment and behavioral symptoms, which interfere with social function and need help from daily living activities; severe or even complete loss of independence, requiring round-the-clock care. If early diagnosis and effective interventions in the early stages of the disease, it will help delay the disease into the moderate and severe stages, prolong the quality of life of patients, and greatly reduce the social burden of care and treatment.
At present, the treatment of AD is mainly symptomatic treatment, mainly including cholinesterase inhibitors and NMDA receptor antagonists. Phase-phase clinical trials show that luncinelizumab has a positive impact on cognitive function and pathological indicators in patients with early AD, delaying the early AD disease process by up to 27% relative to placebo treatment. Lencanizumab, a disease-modifying therapy for early AD, has been approved by FDA and NMPA in China. With the wide clinical application, the clinical efficacy and safety of lencanizumab combined with classical symptomatic therapy have attracted great attention. However, there are still few studies on the clinical characteristics, diagnosis and treatment patterns, efficacy and safety of the combination, and clinical outcomes of patients with early AD in the real world.
Based on this, this study intends to conduct an 18-month multi-center prospective real-world observational cohort study exploring the clinical characteristics, diagnosis and treatment patterns, efficacy and safety of the combination, caregiver and family burden of real-world early AD patients (MCI-AD and mild AD).
Detailed description
This study aims to establish a multicenter prospective real-world observational cohort study covering Northeast China, aiming to explore the clinical efficacy and safety of early AD patients combined with conventional drug therapy (luncainizumab combined with conventional drugs), describe the biomarkers and neuroimaging characteristics of early AD (MCI-AD and mild AD) patients in Northeast China; evaluate the cognitive function, daily living ability and neuropsychiatric symptoms of follow-up early AD patients for 18 months; Vertical investigation of family economic burden, caregiver burden, and medical resource utilization in early AD patients in northeast China. It further describes the clinical characteristics, diagnosis and treatment patterns, and the changes of related health outcomes in northeast China in the real world clinical diagnosis and treatment environment.
This study is an 18-month multicenter real-world observational cohort study of 120 early AD patients (MCI-AD and mild AD) attending at 6 centers from January to June 2025, completed the first annual visit from July to December 2025, the second annual visit from January to June 2026, and the third annual visit from July to December 2026.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination treatment group | – | –no less than 60 early AD patients (MCI-AD and mild AD) were selected from 10 centers from January 2025 to June 2025. 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 criteria for AD. The MCI diagnosis met the MCI diagnostic criteria for the 2004 Peterson. |
| Conventional symptomatic treatment group | – | –no less than 60 early AD patients (MCI-AD and mild AD) were selected from 20 centers from January 2025 to June 2024. 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 criteria for AD. The MCI diagnosis met the MCI diagnostic criteria for the 2004 Peterson. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2025 to June 2025, 120 patients with early AD (MCI-AD and mild AD) who met the inclusion and exclusion criteria and were confirmed to have amyloid protein deposition by biomarkers were selected from 10 centers. Among them, 60 patients were treated with lecanemab combined with symptomatic medication, and the other 60 patients were treated with conventional symptomatic medication.
Key inclusion criteria (9 listed)
- Patients aged 50 and 85 years old, male or female;
- 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.
- 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;
- The presence of amyloid deposits was confirmed by biomarkers: imaging or cerebrospinal fluid biomarkers.
- 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;
Key exclusion criteria (9 listed)
- 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.);
- 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.);
- 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;
- 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)
- Severe stroke sequelae (mRS> 3 or previous stroke history);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy and safety of conventional symptomatic drugs combined with lencanizumab in the treatment of early Alzheimer's disease
Time frame: After collecting the medical information of each follow-up period, the measurement and analysis results will be measured and analyzed.
Statistical difference in CDR and CDR-SB scores from baseline at 6,12 and 18 months, and in the incidence of adverse reaction events between the two groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Background: PubMed 36449413van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29.
- Background: PubMed 34101796Porsteinsson AP, Isaacson RS, Knox S, Sabbagh MN, Rubino I. Diagnosis of Early Alzheimer's Disease: Clinical Practice in 2021. J Prev Alzheimers Dis. 2021;8(3):371-386. doi: 10.14283/jpad.2021.23.
- Background: PubMed 29357799Davis M, O Connell T, Johnson S, Cline S, Merikle E, Martenyi F, Simpson K. Estimating Alzheimer's Disease Progression Rates from Normal Cognition Through Mild Cognitive Impairment and Stages of Dementia. Curr Alzheimer Res. 2018;15(8):777-788. doi: 10.2174/1567205015666180119092427.
- Background: PubMed 33603015Cho SH, Woo S, Kim C, Kim HJ, Jang H, Kim BC, Kim SE, Kim SJ, Kim JP, Jung YH, Lockhart S, Ossenkoppele R, Landau S, Na DL, Weiner M, Kim S, Seo SW. Disease progression modelling from preclinical Alzheimer's disease (AD) to AD dementia. Sci Rep. 2021 Feb 18;11(1):4168. doi: 10.1038/s41598-021-83585-3.
- Background: PubMed 35841252Cohen S, Cummings J, Knox S, Potashman M, Harrison J. Clinical Trial Endpoints and Their Clinical Meaningfulness in Early Stages of Alzheimer's Disease. J Prev Alzheimers Dis. 2022;9(3):507-522. doi: 10.14283/jpad.2022.41.
- Background王雪莹，李明，卢志明. 阿尔茨海默病生物标志物应用指南及研究进展. 中华预防医学杂志,2022,56(3):262-269.
- Background: PubMed 33271079Jia L, Du Y, Chu L, Zhang Z, Li F, Lyu D, Li Y, Li Y, Zhu M, Jiao H, Song Y, Shi Y, Zhang H, Gong M, Wei C, Tang Y, Fang B, Guo D, Wang F, Zhou A, Chu C, Zuo X, Yu Y, Yuan Q, Wang W, Li F, Shi S, Yang H, Zhou C, Liao Z, Lv Y, Li Y, Kan M, Zhao H, Wang S, Yang S, Li H, Liu Z, Wang Q, Qin W, Jia J; COAST Group. Prevalence, risk factors, and management of dementia and mild cognitive impairment in adults aged 60 years or older in China: a cross-sectional study. Lancet Public Health. 2020 Dec;5(12):e661-e671. doi: 10.1016/S2468-2667(20)30185-7.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huayan Liu study chair
the first affiliated hospital of China medical university, neurology department
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and MCI-AD, Early Stage Alzheimer's Disease, run by First Hospital of China Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huayan Liu, PhD. (+86 13609831417, liuhy@cmu1h.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and safety of conventional symptomatic drugs combined with lencanizumab in the treatment of early Alzheimer's disease (time frame: After collecting the medical information of each follow-up period, the measurement and analysis results will be measured and analyzed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06868030, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.