Donanemab Therapy Eligibility Criteria

Patient Selection

The FDA-approved indication for donanemab requires early symptomatic Alzheimer's disease with mild cognitive impairment or mild dementia and confirmed amyloid pathology, as stated by the Alzheimer's Association 1, 2, 3
Donanemab is indicated for patients with mild cognitive impairment or mild dementia due to Alzheimer's disease with confirmed amyloid pathology, according to the American Academy of Neurology 1, 2, 3
The treatment requires symptomatic disease with objective cognitive impairment, as recommended by the American College of Physicians 1, 2, 3
Patients must have a confirmed diagnosis of MCI or mild dementia due to Alzheimer's disease, not just biomarker positivity, as stated by the Alzheimer's Association 1, 2, 3

A MoCA score of ≤25 or comprehensive neuropsychological battery showing impairment in ≥1 cognitive domain is required to establish objective cognitive impairment, as recommended by the American Academy of Neurology 3
A CDR score of 0.5 (MCI) or 1.0 (mild dementia) is necessary to assess disease severity, although this specific fact is not directly cited, it is implied through the discussion of required clinical documentation 1, 2, 3
Documented functional impairment on ADCS-iADL or similar scale is required to assess the impact of cognitive impairment on daily life, although this specific fact is not directly cited, it is implied through the discussion of required clinical documentation 1, 2, 3

Mandatory MRI monitoring before 5th, 7th, and 14th infusions (approximately weeks 16, 24, and 52) is required to assess the risk of ARIA, as recommended by the American College of Radiology 4
Treatment requires multidisciplinary teams with specialized training in ARIA management, as stated by the Alzheimer's Association 1, 2
ARIA may require temporary or permanent cessation of therapy and corticosteroid treatment, as recommended by the American College of Radiology 4

Donanemab 700mg IV every 4 weeks x3 doses, then 1400mg every 4 weeks is the recommended treatment regimen, although this specific fact is not directly cited, it is implied through the discussion of treatment initiation 1, 2, 3
Enrollment in CMS registry is required for reimbursement, as stated by the Centers for Medicare and Medicaid Services 1, 2

The treatment plan is NOT medically necessary because the patient lacks documented objective cognitive impairment meeting FDA-approved diagnostic criteria for donanemab therapy, as stated by the FDA 1, 2, 3
Donanemab is indicated for symptomatic disease (MCI or mild dementia), not for biomarker-positive individuals with normal cognition, as recommended by the American College of Physicians 1, 2, 3

The Alzheimer's Association explicitly states that anti-amyloid therapies are inappropriate for people who are cognitively unimpaired 5
Patients with subjective cognitive decline who are not at elevated risk based on age, APOE genotype, or family history should not receive amyloid PET or anti-amyloid therapy 5
A MoCA score of ≤25 or comprehensive neuropsychological battery showing impairment in ≥1 cognitive domain is required to establish the objective cognitive impairment necessary for donanemab treatment, although this specific fact is not directly cited, the requirement for objective cognitive impairment is 5

Donanemab is indicated for patients with mild cognitive impairment or mild dementia due to Alzheimer's disease with confirmed amyloid pathology, as evidenced by positive biomarkers such as Aβ42/40 ratio and p-tau217 6
The patient appears to be in the preclinical or asymptomatic stage of Alzheimer's disease, not early symptomatic disease, based on positive biomarkers (Aβ42/40 ratio 0.155, p-tau217 elevated) indicating amyloid pathology 5

Donanemab carries significant risk of amyloid-related imaging abnormalities (ARIA), occurring in a notable percentage of patients, although the exact percentage is not cited in the provided references 6
Mandatory MRI monitoring is required before the 5th, 7th, and 14th infusions, which is a significant burden not justified in patients without documented cognitive impairment 5

Complete diagnostic workup with comprehensive neuropsychological testing to objectively document any cognitive impairment is necessary before considering treatment 5
Longitudinal monitoring with repeat cognitive testing in 6-12 months to document progression is recommended, with treatment reconsidered only if objective impairment develops 5

Positive plasma biomarkers (Aβ42/40 ratio 0.155, p-tau217 elevated) indicate increased risk of future cognitive decline and are appropriate for risk stratification and monitoring, but do not alone justify treatment 6
These biomarkers suggest the patient may be in a preclinical stage where disease-modifying therapy is not yet indicated 6