An observational study in Alzheimer's Disease (AD), sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Fudan University · Observational
The goal of this multicenter retrospective observational study is to learn about the real-world safety and clinical effectiveness of disease-modifying therapy (DMT) in adults with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or AD dementia. The main questions it aims to answer are:
What are the safety outcomes of DMT, including amyloid-related imaging abnormalities (ARIA), adverse events, and infusion reactions (IRRs)? How do Clinical Dementia Rating (CDR) measures change in patients who receive DMT compared with those who do not?
Researchers will compare patients who receive DMT as part of their routine clinical care with patients who do not receive DMT to evaluate differences in clinical outcomes and safety.
Participants will not receive any study-assigned intervention or additional treatment as part of this study. Researchers will retrospectively collect existing clinical data, including cognitive and neuropsychiatric assessments, imaging findings, biomarker results, DMT use, and safety information.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 200 across 814 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Alzheimer's disease (AD)-related mild cognitive impairment (MCI) and AD-related dementia.
Disease-Modifying Therapy Group
Non-Disease-Modifying Therapy Group
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The disease-modifying therapy group includes patients with MCI-AD or AD dementia who received disease-modifying therapy during routine clinical practice. Patients were diagnosed based on clinical criteria and available biomarker evidence according to real-world clinical practice. Baseline characteristics, treatment information, clinical outcomes, and safety data will be retrospectively collected and analyzed.
Drug: Disease-Modifying Therapy
The non-disease-modifying therapy group includes patients with MCI-AD or AD dementia who did not receive disease-modifying therapy. Patients may have received conventional symptomatic treatments or other non-disease-modifying treatments according to routine clinical practice. Clinical characteristics, treatment information, clinical outcomes, and safety data will be retrospectively collected and analyzed.
Participants received disease-modifying therapy as part of routine clinical care. Treatment information, including treatment type, dosage, duration, and discontinuation status, will be retrospectively collected from medical records.
Safety of Disease-Modifying Therapy
To evaluate the safety of anti-amyloid disease-modifying therapies (DMTs; lecanemab or donanemab) in patients with Alzheimer's disease (AD)-related mild cognitive impairment (MCI) or AD dementia. Safety outcomes include the occurrence of amyloid-related imaging abnormalities (ARIA), and the number of patients experiencing, incidence proportion (%), and severity of treatment-related adverse events and infusion-related reactions (IRRs).
Time frame: From treatment initiation through up to 30 months of follow-up
Clinical Effectiveness of Disease-Modifying Therapy
To evaluate changes in Clinical Dementia Rating (CDR)-related measures in patients receiving anti-amyloid disease-modifying therapies (DMTs; lecanemab or donanemab) and those receiving usual care, and to compare these changes between the two groups.
Time frame: Baseline and follow-up assessments up to 30 months
Change from baseline in Mini-Mental State Examination total score
The Mini-Mental State Examination (MMSE) assesses global cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function. Change is calculated as the score at each available follow-up assessment minus the baseline score. Changes will be compared between the anti-amyloid treatment and usual-care cohorts.
Time frame: Baseline and follow-up assessments up to 30 months
Change from baseline in Montreal Cognitive Assessment total score
The Montreal Cognitive Assessment (MoCA) assesses global cognitive function. For the standard 30-point version, total scores range from 0 to 30, with higher scores indicating better cognitive function. Change is calculated as the score at each available follow-up assessment minus the baseline score. Changes will be compared between the anti-amyloid treatment and usual-care cohorts. The instrument version and education-adjustment rule will be recorded and applied consistently.
Time frame: Baseline and follow-up assessments up to 30 months
Change From Baseline in Amyloid Positron Emission Tomography (PET) Burden Measured in Centiloids
Amyloid burden is quantified using Centiloid (CL) values. Higher values indicate greater amyloid burden. Change is calculated as the Centiloid value at each available follow-up examination minus the baseline value. Changes will be compared between the anti-amyloid treatment and usual-care cohorts.
Time frame: Baseline and follow-up assessments up to 30 months
Duration of Disease-Modifying Therapy
Treatment duration will be calculated from the date of the first administration of lecanemab or donanemab to the date of the last administration within the observation period and expressed in months.
Time frame: From treatment initiation through up to 30 months of follow-up
Permanent Discontinuation of Disease-Modifying Therapy
The proportion of patients who permanently discontinue lecanemab or donanemab during follow-up will be assessed. Reasons for permanent treatment discontinuation will be recorded and summarized descriptively.
Time frame: From treatment initiation through up to 30 months of follow-up
Change from baseline in the 20-Item Activities of Daily Living Scale Score
The 20-item Activities of Daily Living (ADL) Scale assesses functional independence in daily activities. Total scores range from 20 to 80, with higher scores indicating greater functional impairment. Change is calculated as the score at each available follow-up assessment minus the baseline score. Changes will be compared between the anti-amyloid treatment and usual-care cohorts.
Time frame: Baseline and follow-up assessments up to 30 months
Change from baseline in Hamilton Anxiety Rating Scale total score
The 14-item Hamilton Anxiety Rating Scale (HAMA) assesses anxiety symptom severity. Each item is scored from 0 to 4, yielding a total score from 0 to 56. Higher scores indicate more severe anxiety symptoms. Change is calculated as the score at each available follow-up assessment minus the baseline score. Changes will be compared between the anti-amyloid treatment and usual-care cohorts.
Time frame: Baseline and follow-up assessments up to 30 months
Change from baseline in the 17-Item Hamilton Depression Rating ScaleTotal Score
The 17-item Hamilton Depression Rating Scale (HAMD-17) assesses depressive symptom severity. Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. Change is calculated as the score at each available follow-up assessment minus the baseline score. Changes will be compared between the anti-amyloid treatment and usual-care cohorts.
Time frame: Baseline and follow-up assessments up to 30 months
Change from baseline in the 12-Item Neuropsychiatric Inventory Total Score
The 12-item Neuropsychiatric Inventory (NPI-12) assesses neuropsychiatric symptom severity across 12 domains. Each domain score is calculated by multiplying symptom frequency (1-4) by severity (1-3), with a score of 0 assigned when symptoms are absent. The total score is the sum of the 12 domain scores and ranges from 0 to 144, with higher scores indicating greater neuropsychiatric symptom burden. Caregiver distress scores are not included in the total score. Change is calculated as the score at each available follow-up assessment minus the baseline score. Changes will be compared between the anti-amyloid treatment and usual-care cohorts.
Time frame: Baseline and follow-up assessments up to 30 months
Change From Baseline in Plasma Phosphorylated Tau 217 Concentration
Plasma phosphorylated tau 217 (p-tau217) concentration is measured to assess changes in Alzheimer's disease-related pathology. Change is calculated as the concentration at each available follow-up assessment minus the baseline concentration. Changes will be compared between the anti-amyloid treatment and usual-care cohorts.
Time frame: Baseline and follow-up assessments up to 30 months
Change From Baseline in Plasma Glial Fibrillary Acidic Protein Concentration
Plasma glial fibrillary acidic protein (GFAP) concentration is measured to assess changes in astrocytic activation. Change is calculated as the concentration at each available follow-up assessment minus the baseline concentration. Changes will be compared between the anti-amyloid treatment and usual-care cohorts.
Time frame: Baseline and follow-up assessments up to 30 months
Change From Baseline in Plasma Neurofilament Light Chain Concentration
Plasma neurofilament light chain (NfL) concentration is measured to assess changes in neuroaxonal injury. Change is calculated as the concentration at each available follow-up assessment minus the baseline concentration. Changes will be compared between the anti-amyloid treatment and usual-care cohorts.
Time frame: Baseline and follow-up assessments up to 30 months
Change from baseline in tau positron emission tomography standardized uptake value ratio
Tau burden is quantified using the standardized uptake value ratio (SUVR). Higher values indicate greater tau tracer uptake. Change is calculated as the SUVR at each available follow-up examination minus the baseline value. Changes will be evaluated in the anti-amyloid treatment cohort and compared with the usual-care cohort when sufficient paired data are available.
Time frame: Baseline and follow-up assessments up to 30 months
Changes From Baseline in Magnetic Resonance Imaging (MRI) Findings
Changes in brain structure will be assessed using quantitative magnetic resonance imaging (MRI) measures, including whole-brain volume, hippocampal volume, and other regional brain volumes. Change is calculated as the value at each available follow-up examination minus the baseline value. Changes will be compared between the anti-amyloid treatment and usual-care cohorts where data are available.
Time frame: Baseline and follow-up assessments up to 30 months
Plan to share: No
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Started Oct 2026 (actual). Primary completion is estimated for Jun 2027, 8 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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