Item | Content |
---|---|
Participants | Patients with AD |
Intervention | Anti-AD drugs |
Control | Placebo |
Outcomes | Clinical outcomes: cognitive improvements (e.g., Alzheimer’s Disease Assessment Scale-Cognitive section), activity of daily living (Alzheimer’s Disease Cooperative Study ADL scale). |
Biomarker outcomes: plasma and cerebrospinal fluid biomarkers (e.g., amyloid-β, tau) | |
Neuroimaging outcomes: structural magnetic resonance imaging (e.g., whole brain volume, hippocampal volume), positron emission computed tomography (e.g., standard uptake value ratio of glucose, amyloid-β, tau), etc. | |
Safety outcomes: adverse events, serious adverse events, death, etc. | |
Study design | Phase III clinical trials, which are always randomized controlled trials |