Everyone is hurling content over the pay-wall. In a time when we should be diffusing knowledge, the monetization beckons and many move deeper into their echo chamber.
That is why my favorite read has been QuantaMagazine. Light-Triggered Genes Reveal the Hidden Workings of Memory saved my morning.
Adaptive Phase II Study of BAN2401 in Early Alzheimer’s Disease Continues toward 18-Month EndpointCriteria for Success at 12-Month Analysis of ADCOMS Not Met
Study to Remain Blinded Per Protocol until Final Readout of Comprehensive 18-Month Data
Study 201 (ClinicalTrials.gov identifier NCT01767311) is a placebo-controlled, double-blind, parallel-group, randomized study in patients with prodromal or mild Alzheimer’s disease (collectively known as early Alzheimer’s disease) and with positive biomarkers for brain amyloid pathology.
ADAPTIVE PHASE II STUDY OF BAN2401 IN EARLY ALZHEIMER’S DISEASE CONTINUES TOWARD 18-MONTH ENDPOINT
1.Criteria for success at 12-month analysis of The Alzheimer's disease Composite Score (ADCOMS) not met but study is still continuing. I am curious about the in-house developed endpoint ADCOMS to measure efficacy.
Assessment of safety reasons for stopping were not met--but what were the safety signals? Amyloid related imaging abnormalities (ARIA)? What were the interoperability scores for results?
2. Original primary outcomes was a 12-month time frame and now the current status 18 months (submitted 9.17.2015)
3. Secondary outcomes include hippocampal volume, composite clinical score (ADCOMS), and brain amyloid measured by amyloid PET.
4. The Bayesian design is a responsive design allowing "automatic changes to the design during the study, including adaptively changing the subject allocation ratio to treatment arms with higher probabilities based on the results of interim analyses in order to more efficiently identify the effectiveness and optimal dose regimen of BAN2401."
The ADCOMS measures what investigators want it to measure. Composite study end points should focus separately on safety and effectiveness outcomes, and design separate composite end points to match these different clinical goals. Instead ADCOMS includes 4 Alzheimer's Disease Assessment Scale–cognitive subscale items, 2 Mini-Mental State Examination items, and all 6 Clinical Dementia Rating—Sum of Boxes items (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care)