Participant feature | Clinical trial enrollment criteria | Appropriate use in clinical practice |
Age | 50-85 | Younger or older patients meeting all other criteria for treatment could be considered candidates for aducanumab. |
Diagnosis | Clinical criteria for MCI due to AD or mild AD dementia | Clinical criteria for MCI due to AD or mild AD dementia. |
Scale scores at baseline | CDR Global Score 0.5; MMSE 24-30; RBANS Delayed Memory Score of 85 or less | MMSE 21-30 or equivalent such as MoCA 17-30. |
Amyloid status | Amyloid-positive PET (visual read) | Amyloid-positive PET (visual read) or CSF findings consistent with AD. |
Genetic testing | Consent for APOE genotyping | Genotyping should be discussed with the patient/care partner. ARIA risk should be described, and the patient's preferences assessed. |
Neurological examination | Non-AD neurologic disorders, stroke, and TIA excluded | Non-AD neurologic disorders excluded. |
Cardiovascular history | Angina; myocardial infarction; congestive heart failure excluded | Stable cardiovascular conditions required; clinical decision can be exercised on the ability of the patient to participate safely with the therapeutic regimen. |
Medical history | Excluded: clinically significant systemic illness; diabetes than cannot be managed; uncontrolled hypertension (systolic >165; diastolic >100); history of cancer unless in remission for 5 years or localized to skin or prostate; impaired liver function; hepatitis; HIV infection | Stable medical conditions required; clinical decision can be exercised on the ability of the patient to participate safely with the therapeutic regimen. |
Psychiatric history | Unstable psychiatric illness in the past 6 months; alcohol or substance abuse in the past year; use of cannabinoids; positive urine tests for excluded substances | Must be stable psychiatrically; clinical decision can be exercised on the ability of the patient to participate safely with the therapeutic regimen. |
Reproductive status | Female subjects who are pregnant or breast feeding excluded; female subjects who are of childbearing age must be practicing contraception | Female subjects who are pregnant or breast feeding excluded; female subjects who are of childbearing age must be practicing contraception. |
Clotting status | Bleeding disorders, anticoagulants excluded | Patients on anticoagulants are excluded. |
Concomitant medications | Cholinesterase inhibitors and memantine allowed | Patients can be on standard of care with cholinesterase inhibitors and memantine. |
Baseline MRI | Baseline MRI finding that excluded participation: acute or subacute hemorrhage, macrohemorrhage, greater than 4 microhemorrhages, cortical infarction (>1.5 cm), 1 lacunar infarction (>1.5 cm), superficial siderosis, or diffuse white matter disease | Patients should be excluded if there is evidence of acute or subacute hemorrhage, macrohemorrhage, greater than 4 microhemorrhages, cortical infarction (>1.5 cm), 1 lacunar infarction (>1.5 cm), >1 area of superficial siderosis, or diffuse white matter disease. |
Care support | Reliable informant or care partner | May be living independently or with a care partner. |
Informed consent | Must be signed by participant and care partner | Patient and care partner must understand the nature and requirements of therapy (eg, monthly infusions to be performed indefinitely) and the expected outcome of therapy (slowing of decline of clinical features). |