Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease in Real World Practice

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter retrospective observational analysis focusing on adults with mild cognitive impairment or Alzheimer’s disease dementia who have amyloid pathology. Researchers will retrospectively collect existing medical data to examine safety outcomes such as ARIA, adverse events, and infusion reactions, and to compare changes in Clinical Dementia Rating between patients treated with DMT and those not treated with DMT. No new treatments will be given as part of the study; the aim is to see how DMT performs in real-world clinical settings. The study leverages routine clinical care data from participating centers to assess both safety and clinical effectiveness over time.

Why it matters

Who can join: the full rules

Disease-Modifying Therapy Group

1. 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.
2. Age ≥18 years at baseline.
3. Patients who have received disease-modifying therapy (DMT).
4. Alzheimer's disease-related amyloid pathology confirmed or supported by amyloid positron emission tomography (PET), cerebrospinal fluid (CSF) biomarkers, or blood biomarkers.
5. 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

1. 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.
2. Age ≥18 years at baseline.
3. Patients who have not received disease-modifying therapy (DMT).
4. Alzheimer's disease-related amyloid pathology confirmed or supported by amyloid positron emission tomography (PET), cerebrospinal fluid (CSF) biomarkers, or blood biomarkers.
5. Written or electronic informed consent provided by the patient when cognitive capacity permits, or by the patient's legally authorized representative or guardian.

Exclusion Criteria

1. 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.
2. Amyloid-beta (Aβ) pathological evidence is missing or does not meet the study requirements.
3. Presence of a major neurological disorder that may confound the assessment of cognitive outcomes.
4. Previous treatment with other anti-amyloid monoclonal antibodies, or participation in an interventional clinical trial that may affect the assessment of study outcomes.
5. Serious inconsistencies or errors in key participant information.

Where it's running

• Huashan Hospital, Fudan University, No. 12 Wulumuqi Middle Road, Jing'an District, Shanghai
  Shanghai, Jingan, China Recruiting

Study contacts

• Study coordinator: Jintai Yu, MD
• Email: jintai_yu@fudan.edu.cn
• Phone: +86 21 52888163

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.