NCT07923812Recruiting
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- 26 Oct 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Fudan University
- Diseases
- Alzheimer disease
- NCT number
- NCT07923812
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 26 Oct 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with other anti-amyloid monoclonal antibodies, or participation in an interventional clinical trial that may affect the assessment of study outcomes.
Other illness
- Presence of a major neurological disorder that may confound the assessment of cognitive outcomes.
Other
- The patient, when cognitive capacity permits, explicitly refuses to provide informed consent, or the patient's legally authorized representative or guardian refuses to provide consent on the patient's behalf, either in written or electronic form.
- Amyloid-beta (Aβ) pathological evidence is missing or does not meet the study requirements.
- Serious inconsistencies or errors in key participant information.
Criteria the registry did not label
- Disease-Modifying Therapy Group
- Patients with a baseline diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or dementia due to AD according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
- Age ≥18 years at baseline.
- Patients who have received disease-modifying therapy (DMT).
- Alzheimer's disease-related amyloid pathology confirmed or supported by amyloid positron emission tomography (PET), cerebrospinal fluid (CSF) biomarkers, or blood biomarkers.
- Written or electronic informed consent provided by the patient when cognitive capacity permits, or by the patient's legally authorized representative or guardian.
- Non-Disease-Modifying Therapy Group
- Patients with a baseline diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or dementia due to AD according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
- Age ≥18 years at baseline.
- Patients who have not received disease-modifying therapy (DMT).
- Alzheimer's disease-related amyloid pathology confirmed or supported by amyloid positron emission tomography (PET), cerebrospinal fluid (CSF) biomarkers, or blood biomarkers.
- Written or electronic informed consent provided by the patient when cognitive capacity permits, or by the patient's legally authorized representative or guardian.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University, No. 12 Wulumuqi Middle Road, Jing'an District, Shanghai Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.