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RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: testing Disease-Modifying Therapy for Alzheimer's Disease (AD)

The goal of this multicenter retrospective watch-and-measure (no experimental treatment required) 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), side effects, and infusion reactions (IRRs)?

Official registry: https://clinicaltrials.gov/study/NCT07923812 · Fudan University · enrollment listed as 3,000

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 3,000 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study

Interventions: Disease-Modifying Therapy

Primary outcome (registry wording): Safety of Disease-Modifying Therapy

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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
  • Non-Disease-Modifying Therapy Group
  • Patients who have not received disease-modifying therapy (DMT)

Public study contact (from the registry)

Jintai Yu, MD

+86 21 52888163

jintai_yu@fudan.edu.cn

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07923812 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07923812?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07923812?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary