Alzheimer's disease
ICD-10 G30 · ICD-11 8A20

Treatment of Early Alzheimer's Disease with Cognitive Impairment and Confirmed Cerebral Amyloid Pathology

Clinical Scenario

This protocol applies to patients diagnosed with early Alzheimer's disease who have cerebral amyloid pathology confirmed by CSF biomarkers or amyloid-PET, and who present with cognitive impairment of at least mild severity alongside no to mild impairment in activities of daily living.

Eligibility Criteria
Not applicable to: patients with moderate to severe ADL impairment, or those homozygous for APOE ε4 (ineligible in the EU, UK, and Australia due to elevated ARIA risk).
Treatment Approach

The protocol involves anti-β amyloid monoclonal antibody therapy as the primary intervention, with options for co-treatment with established cognitive agents.

Full regimen, agent selection, and schedules available in the structured protocol →
Instant Access to Structured Evidence-Based Regimens

References

DOI: 10.1016/S0140-6736(25)01329-7

Trial requirements, mirrored by market labels, included a diagnosis of cognitive impairment with no to mild activities of daily living impairment and evidence of cerebral amyloid pathology based on CSF biomarkers or amyloid-PET.

Therefore, patients with cognitive impairment due to alternative clinical diagnoses or more advanced Alzheimer's disease with moderate to severe ADL impairment should be excluded.

In the EU, the UK, and Australia, patients who are homozygous for APOE ε4 are not eligible for anti-β amyloid monoclonal antibodies due to the higher ARIA incidence.

Donanemab intravenously every 4 weeks; lecanemab intravenously every 2 weeks; and subcutaneous formulations under development.

The clinical trials of donanemab and lecanemab allowed co-treatment with cholinesterase inhibitors, memantine, or both.

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