Table 3. Summary of inclusion and exclusion criteria in the studies CLARITY-AD 4 and TRAILBLAZER-ALZ 2 6 .
| Donanemab (TRAILBLAZER-ALZ 2) |
Lecanemab (CLARITY-AD) |
|||
|---|---|---|---|---|
| MCI or mild dementia | MMSE in the sample | 20–28 | ≥22 | |
| CDR | - | Global 0.5 or 1.0 | Memory ≥0.5 | ||
| Other | gradual, progressive memory change for ≥6 months | gradual decline in the past year, corroborated | ||
| AD biomarkers | Amyloid PET | positive scan and | positive scan or | |
| CSF | - | t-tau/ Aβ 42 | ||
| Tau PET | positive scan | - | ||
| Characteristics | Age | 60–85 | 50–90 | |
| Sex (% female) | 53.3 | 52.0 | ||
| Race | White 94.9% | White >75.0% | ||
| Black 2.9% | Black ~2.5% | |||
| Asian 1.1% | Asian 17.0% | |||
| BMI | - | 17–35 | ||
| AChE-i or memantine | if stable for 30+ days | if stable for 12+ weeks | ||
| Care partner | Yes | yes | ||
| Excluded health conditions | cause of cognitive impairment | any non-AD condition | any non-AD condition | |
| Laboratory tests | elevated liver enzymes | low B12, high TSH | ||
| TIA/stroke | - | past year | ||
| Seizure | recurrent seizures (except childhood febrile seizures) | past year | ||
| Immune/Allergy | significant multiple or severe drug allergies | immunologic disease that is uncontrolled or requires systemic therapy | ||
| Psychiatric | interfering, actively suicidal, or chronic psychosis | interfering, GDS ≥8, suicidal behavior (5 years) | ||
| Cancer | past five years (except those with a low risk of spread) | past three years (except skin/prostate) | ||
| HIV | - | known HIV+ | ||
| Substance use | drug use disorder for the past two years | dependence or abuse for the past two years | ||
| Bleeding | - | uncontrolled, e.g. platelets < 50.000 or INR >1.5 | ||
| MRI exclusions | Microhemorrhage | >4 microhemorrhages | >4 microhemorrhages | |
| Macrohemorrhage | any macrohemorrhage | any macrohemorrhage (10 mm) | ||
| Siderosis | more than one area of superficial siderosis | any superficial siderosis | ||
| Small vessel disease | severe white matter disease | severe small vessel disease | ||
| Other | any clinically significant finding that would impact safe participation in the study | vasogenic edema, tumefactive lesions, tumor/mass (except small meningioma or cyst), contusion, encephalomalacia, aneurysm, inflammatory amyloid angiopathy | ||
Abbreviations: MCI, mild cognitive impairment; MMSE, Mini-Mental State Examination; PET, positron emission tomography; CSF, cerebrospinal fluid; t-tau, total tau; AChE-I, acetylcholinesterase inhibitors; BMI, body mass index, Aβ, amyloid beta; AD, Alzheimer’s disease; TIA, transient ischemic attack; GDS, geriatric depression scale; HIV, human immunodeficiency virus; TSH, thyroid stimulating hormone; INR, international normalized ratio; MRI, magnetic resonance imaging.