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Clinical Trials for Disease-Modifying Therapies in Alzheimer’s Disease: A Primer, Lessons Learned, and a Blueprint for the Future

Welcome! Before you get started, here are the steps to receiving your credit:
 
Step 1: Take the post-test. You may take this post-test as many times as you need, but you must answer at least 70% correctly to receive credit.
Step 2: Complete the checkout page to purchase your credits ($30). 
Step 3: Complete the evaluation form which will be offered at the end of your post-test.
Step 4: We will e-mail your CME/CPD certificate within 7 days.
 
 
These CME/CPD credits offered are AMA PRA Category 1 Credits™ through ACCME.
Which of the following features of a drug are not defined in a Target Product Profile (TPP)?
Patient Population
Dosage
Cost
Tolerability
Which of the following factors of a test agent are not required to be known by the end of Phase II?
Safety and dosing
Safety and tolerability
Tolerability and target engagement
Safety and ADME
The average time required for the development of an Alzheimer's disease treatment is ____ years and the average cost is ______.
13 years; $5.6 million
13 years; $5.6 billion
15 years; $4.2 billion
11 years; $4.2 million
What form of analysis can be used to screen for effects on synapse number, synaptic integrity, neuron number, apoptosis, and protein aggregation?
High content analysis
Low content analysis
High structural analysis
Low structural analysis
Which of the following has not been a reason for failure to show a drug-placebo difference at the end of a clinical trial of a disease-modifying agent?
Excessive toxicity or lack of tolerability leading to high discontinuation rates in the active treatment arms
Lack of efficacy of the agent
Excessive tolerability leading to early termination of the trial
Inappropriately low dosing of an effective agent
During what stage(s) of a clinical trial is a maximum tolerated dose typically determined?
Phase I
Phase II
Phase IV
Phase I and Phase II
None of the above
Polyclonal antibodies are targeted to specific molecular sites and thus have less risk for off-target effects.
True
False
During what stage of Alzheimer's disease is atrophy first detectable in an MRI?
AD Dementia
Preclinical AD
Prodromal AD
None of the above
The clinical diagnosis of AD dementia is confirmed by amyloid or SCF amyloid tau measures in approximately 25% of patients diagnosed clinically with AD.
True
False
Typically, Phase III is the longest phase of development for an Alzheimer's disease treatment.
True
False
Welcome! Before you get started, here are the steps to receiving your credit:
 
Step 1: Take the post-test. You may take this post-test as many times as you need, but you must answer at least 70% correctly to receive credit.
Step 2: Complete the checkout page to purchase your credits ($30). 
Step 3: Complete the evaluation form which will be offered at the end of your post-test.
Step 4: We will e-mail your CME/CPD certificate within 7 days.
 
 
These CME/CPD credits offered are AMA PRA Category 1 Credits™ through ACCME.
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