The need for thorough phase II studies in medicines development for Alzheimer's disease.
An important factor in the universal failure in phase III trials in mild to moderate Alzheimer's disease in the past decade is the lack of phase II clinical data prior to entering phase III, with common reliance on biomarker results alone. Conduction of two learn-confirm cycles according to the Sheiner model would allow go/no-go decision making to include reliable clinical efficacy data prior to conducting phase III and would likely bring the rate of late stage failure more into line with that of other neurological indications. In studies in earlier disease stages, combined phase IIB/III adaptive approaches merit consideration in view of the long timelines of each study, though advantages and disadvantages of this approach versus the classical development pathway still need careful assessment.
, Neuroglobe Ltd, Baarerstrasse 135, 6301, Zug, Switzerland. j.gray@graybook.net.
Julian A
JA
Gray
, Datamagik Ltd, Laburnum House, East Grimstead, Salisbury, Wiltshire, SP5 3RT, UK.
David
D
Fleet
Karolinska Institutet, Department NVS, Center for Alzheimer Research, Division for Neurogeriatrics, Novum plan 5, 14157, Huddinge, Sweden.
Bengt
B
Winblad
D000544:Alzheimer Disease / Q000188:drug therapy* / Q000378:metabolism; D054316:Biomarkers, Pharmacological / Q000378:metabolism; D017322:Clinical Trials, Phase II as Topic; D055808:Drug Discovery / Q000379:methods; D006801:Humans
D054316:Biomarkers, Pharmacological