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(Solved): The descriptions below are of four different trials that were recently completed for different hypo ...



The descriptions below are of four different trials that were recently completed for different hypothetical drugs intended to treat Alzheimer’s disease. Each trial represents a different stage of the drug development process (preclinical research and phase 1, phase 2, and phase 3 clinical trials). Which stage of development is represented by each trial? 1. A randomized, double-blind, placebo-controlled trial in 84 subjects with mild-moderate Alzheimer’s disease to evaluate the safety and efficacy of ABC654, a monoclonal antibody that targets beta-amyloid. Subjects receive one of three doses of the drug (10mg, 20mg, or 40mg) or placebo. The primary outcome measure is change from baseline in the ADAS-cog after 12 weeks of treatment. 2. A trial testing the effect of 1,943 different small molecule drugs on processing of amyloid precursor protein in Chinese hamster ovary cells. Lab-grown cells were treated with each drug at a concentration of 10 uM for 48 hours and the processing of amyloid precursor protein was measured using a biochemical assay. 3. Drugs can be delivered to specific cells using monoclonal antibodies via a technique known as antibody conjugation – the antibody “targets” the drug to specific cells. IC735 is one such antibody-conjugated drug that was studied in a trial of 6 subjects with mild-moderate Alzheimer’s disease to learn how much conjugated antibody is found in the blood following intravenous administration, and to determine if there are any side-effects of taking a 10 mg dose twice daily for one week. The primary outcome measure was a correlation between drug intake and plasma levels of the drug, and the secondary outcome measure was safety as indicated by changes in weight, blood count, electrolytes, liver function, and kidney function in study subjects. 4. A randomized, double-blinded, placebo-controlled trial in 692 subjects with mild-moderate Alzheimer’s disease to evaluate the efficacy and safety of NO-AD, a tree-derived carbohydrate that targets beta-amyloid, neuroinflammation, and other manifestations of the disease. Subjects received either 250 mg of the study drug or a placebo twice per day. The primary outcome measure was improvement on the ADAS-cog after 36 weeks.



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