Alzheimer DiseaseNCT06883019
Lecanemab for Early Onset Familial Alzheimer's Disease
An observational study of Alzheimer Disease, run by RenJi Hospital at 15 sites in China.
Trial summary
The goal of this observational study is to learn about the efficacy of Lecanemab treatment for early-onset familial Alzheimer's disease (AD) in patients under 65 years of age with a family history of AD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alzheimer Disease
- How many people
- 114 participants
- Where
- 15 sitesChina
- Study dates
- 13 Mar 2025to 31 Aug 2027
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Renji Hospital, Shanghai Jiao Tong University School of Medicine Xuanwu Hospital, Capital Medical University Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Mental Health Center The First Affiliated Hospital, Zhejiang University School of Medicine The Second Affiliated Hospital of Guangzhou Medical University West China Hospital of Sichuan University Tianjin Medical University General Hospital Nantong First People's Hospital Huadong Hospital, Fudan University Jinhua Central Hospital Ningbo Second Hospital Nanjing Drum Tower Hospital Nanjing Brain Hospital The Affiliated Hospital of Guizhou Medical University
Who may be able to join
- Age at onset ≤ 65 years, with a minimum age of 18 years; no restriction on gender.
- Diagnosis of Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI): Must meet the clinical diagnostic criteria for AD-related MCI and mild AD as defined by the National Institute on Aging and the Alzheimer's Association (NIA-AA) (2011); confirmed Aβ positivity through Aβ-PET/CT, Aβ-PET/MRI, or cerebrospinal fluid testing.
- MMSE ≥ 21 or MoCA ≥ 17 or CDR = 0.5
- No significant signs found in the neurological examination
- Participants must be capable of completing cognitive assessments and other tests.
- Informed consent must be obtained from the participants and their legal guardians, with a dated signature, prior to any operations or tests related to the protocol, committing to comply with the research procedures and cooperate throughout the study process.
Who cannot join
- Cognitive decline caused by other reasons: cerebrovascular disease, central nervous system infections, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic dementia, other physical and chemical factors (drugs, alcohol, CO, etc.), significant systemic diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (subdural hematoma, brain tumor), endocrine system disorders (thyroid disease, parathyroid disease), and dementia caused by vitamin deficiencies or any other reasons.
- Patients with other unstable diseases, or those who have had a stroke or transient ischemic attack, bleeding disorders, or seizures within the previous 12 months.
- Patients with psychiatric disorders who meet DSM-IV criteria for schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium.
- Patients with unstable or severe heart, lung, liver, kidney, hematological diseases; those with known malignancies or other serious prognoses.
- Exclusion of cerebral amyloid angiopathy-related inflammation/β-amyloid-related cerebral vasculitis (CAAri/ABRA).
- Presence of uncorrectable visual or auditory impairments that prevent completion of relevant assessments or scales.
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- Patients who cannot undergo MRI due to claustrophobia, pacemakers, defibrillators, or metal implants.
- MRI findings showing more than four microhemorrhages (diameter < 10 mm), evidence of surface iron deposition, vascular edema, diffuse white matter disease, multiple lacunar strokes, or any strokes involving major vascular regions. Presence of evidence of cerebral contusions, brain softening, cerebral aneurysms, or other vascular malformations, central nervous system (CNS) infections, as well as brain tumors other than meningiomas or arachnoid cysts.
- Patients taking warfarin, vitamin K antagonists, or direct oral anticoagulants (dabigatran, rivaroxaban, edoxaban, apixaban, betrixaban) or heparin; patients receiving thrombolysis; patients with coagulation disorders.
- Pregnant or lactating women.
- Patients deemed unsuitable for use by clinicians apart from the exclusion criteria listed above.
- Patients with severe allergies to lecanemab or any excipients of this product.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, China
Cuibai Wei, +86 13910076457, weicb@xwhosp.org
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangdong, China
Jun Liu, +86 13609794537, liujun@gzhmu.edu.cn
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guizhou, China
Dian He, +86 15285948199, hedian@gmc.edu.cn
- Recruiting
Nanjing Brain Hospital
Jiangsu, China
Weiguo Liu, +86 13914725569, liuweiguo1111@sina.com
- Recruiting
Nanjing Drum Tower Hospital
Jiangsu, China
Hui Zhao, +86 13605140127, zhaohuigyc2002@163.com
- Recruiting
Nantong First People's Hospital
Jiangsu, China
Xiangyang Zhu, +86 13962978278, zhuxxyy@163.com
- Recruiting
Huadong Hospital, Fudan University
Shanghai, China
Wenshi Wei, wenshiwei1999@163.com
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Jinwen Xiao, +86 13917310784, jw_xiao78@163.com
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Rujing Ren, +86 13917771617, doctorren2001@126.com
- Recruiting
Shanghai Mental Health Center
Shanghai, China
Xia Li, +86 13774272543, lixia1111102@163.com
- Recruiting
West China Hospital of Sichuan University
Sichuan, China
Qin Chen, +86 18980606301, chen.qin@scu.edu.cn
- Recruiting
Tianjin Medical University General Hospital
Tianjin, China
Nan Zhang, +86 22 6036 2255, nkzhangnan@163.com
- Recruiting
Jinhua Central Hospital
Zhejiang, China
Xiaoling Pan, +86 15167966680, icangetit007@163.com
- Recruiting
Ningbo Second Hospital
Zhejiang, China
Weinv Fan, +86 13685701750, 13685701750@163.com
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang, China
Guoping Peng, +86 13588150613, guopingpeng@zju.edu.cn
About this study
Official title: A Real World Study of Lecanemab Treatment in Participants with Early Onset Familial Alzheimer's Disease
The goal of this observational study is to learn about the efficacy of Lecanemab treatment for early-onset familial Alzheimer's disease (AD) in patients under 65 years of age with a family history of AD. Participants will receive Lecanemab at a dosage of 10 mg/kg every two weeks for a total of 18 months and will undergo cognitive assessments, PET and MRI scans, blood/fluid tests and whole genome sequencing. The study will explore the effects of genetic and hereditary factors on the efficacy of Lecanemab treatment in early-onset familial AD patients.
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Chang of CDR-SB score
CDR-SB, clinical dementia rating-sum of boxes
Measured: baseline, 9 month, 18 month
Secondary outcomes (15)
Change of amyloid burden
AV45-PET
Measured: baseline, 9 month, 18 month
Change of ADAS-cog score
ADAS-cog, the Alzheimer's Disease Assessment Scale-Cognitive Subscale
Measured: baseline, 9 month, 18 month
Change of ADCS-ADL score
ADCS-ADL, the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL)
Measured: baseline, 9 month, 18 month
Change of MoCA score
MoCA, the Montreal Cognitive Assessment
Measured: baseline, 9 month, 18 month
Change of BNT score
BNT, the Boston Naming Test
Measured: baseline, 9 month, 18 month
Change of TMT score
TMT, the trail making test
Measured: baseline, 9 month, 18 month
Change of HAMA and HAMD score
HAMA, Hamilton Anxiety Scale; HAMD, Hamilton Depression Scale
Measured: baseline, 9 month, 18 month
Change of biomarkers
p-tau181, p-tau217, Aβ40, Aβ42 , pEAβ3-42, GFAP, NFL, TRPC6 ( blood, urine, feces, gingival crevicular fluid, cerebrospinal fluid)
Measured: baseline, 9 month, 18 month
Positron emission tomography (PET)
Other PET including FDG-PET, Tau-PET, TSPO-PET, SV2A-PET, exendin-4 (GLP-1R)-PET, colinergic receptor probe (ASEM) PET
Measured: baseline, 9 month, 18 month
Change of structural MRI
3D T1-weighted, 3D T2-weighted and Diffusion Tensor Imaging (DTI)
Measured: baseline, 9 month, 18 month
Change of functional MRI
Blood oxygenation level dependent (BOLD) imaging
Measured: baseline, 9 month, 18 month
Change of magnetic susceptibility
Quantitative susceptibility mapping (QSM) imaging
Measured: baseline, 9 month, 18 month
Change of perfusion imaging
Arterial spin labeling (ASL) imaging
Measured: baseline, 9 month, 18 month
Whole Genome Sequencing
Measured: baseline
Change of speech information
Speech recording of Cookie-theft description task, using self-developed ASR speech analysis software (China software copyright number: 2016RS164680) for speech analysis
Measured: baseline, 9 month, 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start13 Mar 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Gang, RenJi Hospital
- Investigators
- Gang Wang, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883019
- Sponsor's protocol ID
- LEOFAD-01
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Lecanemab Treatment in Participants with Early Onset Familial Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06883019
- Acronym / sponsor ID
- LEOFAD-01
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 13 Mar 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 19 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.
The goal of this observational study is to learn about the efficacy of Lecanemab treatment for early-onset familial Alzheimer's disease (AD) in patients under 65 years of age with a family history of AD. Participants will receive Lecanemab at a dosage of 10 mg/kg every two weeks for a total of 18 months and will undergo cognitive assessments, PET and MRI scans, blood/fluid tests and whole genome sequencing. The study will explore the effects of genetic and hereditary factors on the efficacy of Lecanemab treatment in early-onset familial AD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Renji Hospital, Shanghai Jiao Tong University School of Medicine Xuanwu Hospital, Capital Medical University Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Mental Health Center The First Affiliated Hospital, Zhejiang University School of Medicine The Second Affiliated Hospital of Guangzhou Medical University West China Hospital of Sichuan University Tianjin Medical University General Hospital Nantong First People's Hospital Huadong Hospital, Fudan University Jinhua Central Hospital Ningbo Second Hospital Nanjing Drum Tower Hospital Nanjing Brain Hospital The Affiliated Hospital of Guizhou Medical University
Key inclusion criteria (6 listed)
- Age at onset ≤ 65 years, with a minimum age of 18 years; no restriction on gender.
- Diagnosis of Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI): Must meet the clinical diagnostic criteria for AD-related MCI and mild AD as defined by the National Institute on Aging and the Alzheimer's Association (NIA-AA) (2011); confirmed Aβ positivity through Aβ-PET/CT, Aβ-PET/MRI, or cerebrospinal fluid testing.
- MMSE ≥ 21 or MoCA ≥ 17 or CDR = 0.5
- No significant signs found in the neurological examination
- Participants must be capable of completing cognitive assessments and other tests.
Key exclusion criteria (12 listed)
- Cognitive decline caused by other reasons: cerebrovascular disease, central nervous system infections, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic dementia, other physical and chemical factors (drugs, alcohol, CO, etc.), significant systemic diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (subdural hematoma, brain tumor), endocrine system disorders (thyroid disease, parathyroid disease), and dementia caused by vitamin deficiencies or any other reasons.
- Patients with other unstable diseases, or those who have had a stroke or transient ischemic attack, bleeding disorders, or seizures within the previous 12 months.
- Patients with psychiatric disorders who meet DSM-IV criteria for schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium.
- Patients with unstable or severe heart, lung, liver, kidney, hematological diseases; those with known malignancies or other serious prognoses.
- Exclusion of cerebral amyloid angiopathy-related inflammation/β-amyloid-related cerebral vasculitis (CAAri/ABRA).
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
Chang of CDR-SB score
Time frame: baseline, 9 month, 18 month
CDR-SB, clinical dementia rating-sum of boxes
15 secondary outcomes
Change of amyloid burden
Time frame: baseline, 9 month, 18 month
Change of ADAS-cog score
Time frame: baseline, 9 month, 18 month
Change of ADCS-ADL score
Time frame: baseline, 9 month, 18 month
Change of MoCA score
Time frame: baseline, 9 month, 18 month
Change of BNT score
Time frame: baseline, 9 month, 18 month
Change of TMT score
Time frame: baseline, 9 month, 18 month
Change of HAMA and HAMD score
Time frame: baseline, 9 month, 18 month
Change of biomarkers
Time frame: baseline, 9 month, 18 month
Positron emission tomography (PET)
Time frame: baseline, 9 month, 18 month
Change of structural MRI
Time frame: baseline, 9 month, 18 month
Change of functional MRI
Time frame: baseline, 9 month, 18 month
Change of magnetic susceptibility
Time frame: baseline, 9 month, 18 month
Change of perfusion imaging
Time frame: baseline, 9 month, 18 month
Whole Genome Sequencing
Time frame: baseline
Change of speech information
Time frame: baseline, 9 month, 18 month
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 19 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Gang Wang principal investigator
RenJi Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by RenJi Hospital at 15 sites in China.
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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jinwen Xiao (+86 13917310784, jw_xiao78@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chang of CDR-SB score (time frame: baseline, 9 month, 18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2025.