Research & Clinical Trials Awareness Flashcards
7 cards from real AAC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Research & Clinical Trials Awareness flashcards as text
Which phase of a clinical trial is the FIRST to test an experimental Alzheimer's drug in human beings?
Answer: Phase I
Phase I trials are the first in-human studies, focusing primarily on safety, tolerability, and dosing in a small group of participants.
What does 'double-blind' mean in the context of an Alzheimer's clinical trial?
Answer: Neither the participants nor the researchers assessing outcomes know who received the treatment or placebo
In a double-blind trial, neither participants nor investigators know the treatment assignment, minimizing bias in assessment and reporting.
The A4 Study (Anti-Amyloid Treatment in Asymptomatic Alzheimer's) targets which population?
Answer: Cognitively normal older adults who show amyloid buildup on PET scans
The A4 Study enrolled cognitively normal older adults with elevated amyloid to test whether removing amyloid before symptoms appear prevents decline.
What is the role of an Institutional Review Board (IRB) in Alzheimer's research?
Answer: To review and approve research protocols to protect the rights and welfare of human participants
An IRB is an independent committee that evaluates the ethical and safety standards of research before and during a study.
Genetic testing for the APOE ε4 allele is relevant in Alzheimer's research because it:
Answer: Is the strongest known genetic risk factor for late-onset Alzheimer's and affects trial eligibility and outcomes
The APOE ε4 allele is the major genetic risk factor for late-onset Alzheimer's and is often used to stratify participants in research studies.
What is a 'run-in period' in the design of an Alzheimer's clinical trial?
Answer: A pre-randomization phase used to assess adherence, washout prior medications, or establish baseline measures
A run-in period occurs before randomization and is used to identify adherent participants, clear previous medications, or collect stable baselines.
Which federal website is the official registry where all U.S. clinical trials must be registered?
Answer: ClinicalTrials.gov
ClinicalTrials.gov is the U.S. National Library of Medicine's registry where sponsors must register clinical trials and report results.