A review of clinical trial designs used to detect a disease-modifying effect of drug therapy in Alzheimer's disease and Parkinson's disease

DJM McGhee, CW Ritchie, JP Zajicek, CE Counsell - BMC neurology, 2016 - Springer
… Whilst the results of disease-modification clinical trials in PD, … statistical analyses, and the
pre-defined trial length; (6) study … agitation and clinical progression of Alzheimer disease. Arch …

Why do so many clinical trials of therapies for Alzheimer's disease fail?

RM Anderson, C Hadjichrysanthou, S Evans… - The Lancet, 2017 - thelancet.com
review of longitudinal studies which measure Alzheimer's … used data from other cohort studies
(eg, Alzheimer's Disease … cases of Alzheimer's disease over the length of the clinical trial (…

Comparing progression biomarkers in clinical trials of early Alzheimer's disease

…, Alzheimer's Disease Neuroimaging … - Annals of Clinical …, 2020 - Wiley Online Library
… In the present study, we assess statistical power from using … clinical trial duration is based
on a review of recent clinicalstatistical analysis, study design, and drafting of manuscript. …

[HTML][HTML] The TOMMORROW study: Design of an Alzheimer's disease delay-of-onset clinical trial

DK Burns, C Chiang, KA Welsh-Bohmer… - Alzheimer's & Dementia …, 2019 - Elsevier
… the design and conduct of future similar clinical trials. … to the anticipated duration of the
TOMMORROW trial. The … in the Statistical Analysis Plan. Details regarding sample size …

Therapeutic strategies for Alzheimer's disease in clinical trials

J Godyń, J Jończyk, D Panek, B Malawska - Pharmacological Reports, 2016 - Elsevier
… these studies, several comprehensive reviews of anti-AD drug … This yielded important data
for further clinical trials involving … uncorrected, poorly designed clinical studies; and moreover, …

… efficacy, and safety of cholinesterase inhibitors for Alzheimer's disease: a meta-analysis and meta-regression of 43 randomized clinical trials enrolling 16 106 patients

L Blanco-Silvente, X Castells, M Saez… - International Journal …, 2017 - academic.oup.com
… of a systematic review and meta-analysis investigating the … We preferred intention-to-treat
analysis data to per-protocol data. … The mean treatment length was 25 weeks and ranged from …

… of the evidence and the redundancy of the research on pharmacological treatment for Alzheimer's disease: a cumulative meta-analysis and trial sequential analysis

L Blanco-Silvente, X Castells, J Garre-Olmo… - … Journal of Clinical …, 2019 - Springer
… randomised clinical trials (RCTs) when intermediate sequential analysesdata extraction
We included placebo-controlled, double-blind, parallel-design RCTs with a minimum duration

Developing effective Alzheimer's disease therapies: clinical experience and future directions

DR Elmaleh, MR Farlow, PS Conti… - … of Alzheimer's …, 2019 - content.iospress.com
review and suggest approaches for AD clinical trial design … overall clinical trial design with
utilized statistical measures that … As the duration, complexity, and cost of clinical trials increase…

[HTML][HTML] Lessons learned from Alzheimer disease: clinical trials with negative outcomes

J Cummings - Clinical and translational science, 2018 - ncbi.nlm.nih.gov
… severe AD dementia) produce a statistically significant difference … A review of the literature
identifies several steps in drug … in trials of 6 months or more duration is indicative of a failed trial

Clinical trials in Alzheimer's disease: a hurdle in the path of remedy

AE Oxford, ES Stewart, TT Rohn - … of Alzheimer's Disease, 2020 - Wiley Online Library
… FDA-regulated clinical trial phases as a function of their length, … The following review of
clinical trial data aims at being … of trial design begin with the designation of clinically meaningful …