NCT07505095 · NOT YET RECRUITING

Efficacy of Lecanemab at Different Therapeutic Doses for Alzheimer's Disease (AD) in Real-World Practice

This study is testing whether a lower dose of lecanemab works as well as the standard approved dose in people with early Alzheimer's disease or amyloid-confirmed MCI. Researchers will track brain imaging, blood biomarkers, and clinical measures before and after treatment to compare the two dose levels. The phase is unspecified, so this appears to be a real-world observational or practice-based study rather than a traditional drug approval trial.

You may qualify if

  • Meet the diagnostic criteria for AD-derived MCI or early AD [Clinical rating: CDR 0.5 (MCI) / 1.0 (mild AD), i.e., clinical stage 3-5; PIB-PET positive for pathology]
  • Male or female
  • 50-85 years old
  • Not currently participating in other research studies
  • Volunteers must provide written informed consent prior to study participation and voluntarily sign the informed consent form
  • Volunteers are able to communicate effectively with investigators and comply with study procedures to complete the study

You're excluded if

  • Other neurological disorders: e.g., vascular dementia, dementia with Lewy bodies, frontotemporal lobar degeneration, prion diseases, etc.
  • Systemic diseases or metabolic disorders: e.g., hypothyroidism, vitamin B12 deficiency, hepatic and renal failure.
  • Infectious diseases: e.g., neurosyphilis, HIV-associated encephalopathy, and other infectious diseases.
  • Psychiatric disorders: cognitive symptoms caused by severe depression (pseudodementia), schizophrenia, etc.
  • Effects of drugs/toxins: long-term use of benzodiazepines, anticholinergic drugs, or alcohol dependence.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-04-01

View full record on ClinicalTrials.gov

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