scholarly journals Do MCI criteria in drug trials accurately identify subjects with predementia Alzheimer's disease?

2005 ◽  
Vol 76 (10) ◽  
pp. 1348-1354 ◽  
Author(s):  
P J Visser
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Drug Trials

scholarly journals What We Learn from the CTAD 2018 (Clinical Trials Alzheimer’s Disease)

2018 ◽  
pp. 1-2
Author(s):  
B. Vellas ◽  
P. Aisen ◽  
M. Weiner ◽  
J. Touchon
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Safety Data ◽  
Phase Iii ◽  
Drug Trials ◽  
New Developments ◽  
Fda Guidance ◽  
Clinical Biomarkers ◽  
Early Alzheimer’S Disease

We are happy to publish the CTAD 2018 abstracts in the present JPAD issue. As you can see many new interesting studies are presented in this issue of the journal: from new drug trials to biomarkers, imaging studies, as well as new clinical outcomes. More specifically, we will have several hot topics presentation on: 1. Major drug trials using bace inhibitors (verubecestat, lanabecestat, atabecestat, elenbecestat…) in the early phase of the disease (APECS early trials…). Both clinical, biomarkers (MRI, CSF, PET) and safety data will be presented. 2. New data on blood biomarkers including a keynote from R. Bateman, and presentations from Araclon and Roche biomarkers. 3. Results from phase III and IIB trials including a novel and multi-targeted oligosaccharide in patients with mild-moderate AD in China; the AMBAR (Alzheimer’s Management By Albumin Replacement) study, the TOMMORROW trial: a trial to delay the onset of MCI due to AD and qualify a genetic biomarker algorithm, the 18-month STEADFAST trial of azeliragon in participants with mild Alzheimer’s Disease; a longitudinal 148-week extension 4. Results 18 from F-AV-1451-A16: a clinicopathological study of the correspondence between flortaucipir PET imaging and post-mortem assessment of tau pathology. 5. Latest developments in anti-amyloid monoclonal antibodies including aducanumab nonnegligible, and new results and data analyses of the BAN2401 study 201 in early AD. 6. New developments with safety and efficacy of lemborexant for sleep-wake regulation in patients with irregular sleep-wake rhythm disorders and Alzheimer’s Disease dementia. 7. Advances with the ABBV-8E12, a humanized anti-tau monoclonal antibody, for the treatment of early Alzheimer’s Disease. 8. Endpoints for early Alzheimer’s Disease clinical trials: interpretation and application of the draft FDA guidance. And many others… It is important to underline that a not negligible number of abstracts concern non amyloid targets (eg: Tau-related targets but also targets outside the classical AD cascade).

scholarly journals Alzheimer's disease: The amyloid hypothesis on trial

2016 ◽  
Vol 208 (1) ◽  
pp. 1-3 ◽  
Author(s):  
Judith R. Harrison ◽  
Michael J. Owen
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Drug Trials ◽  
Amyloid Hypothesis ◽  
Directed Research

SummaryThe pathogenesis of Alzheimer's disease is complex. The amyloid hypothesis has directed research efforts for many years, but it has recently been questioned after failed drug trials. Here, we review the evidence for and against and suggest that it might be premature to abandon the amyloid hypothesis.

Designing drug trials for Alzheimer's disease: What we have learned from the release of the phase III antibody trials: A report from the EU/US/CTAD Task Force

2013 ◽  
Vol 9 (4) ◽  
pp. 438-444 ◽  
Author(s):  
Bruno Vellas ◽  
Maria C. Carrillo ◽  
Cristina Sampaio ◽  
H. Robert Brashear ◽  
Eric Siemers ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Task Force ◽  
Phase Iii ◽  
Drug Trials ◽  
The Eu

Clinical Evaluation of Global Change in Alzheimer's Disease: Identifying Consensus

1996 ◽  
Vol 9 (4) ◽  
pp. 176-180 ◽  
Author(s):  
Jason T. Olin ◽  
Lon S. Schneider ◽  
Rachelle S. Doody ◽  
Christopher M. Clark ◽  
Steven H. Ferris ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Global Change ◽  
Clinical Global Impression ◽  
Care Giver ◽  
Drug Trials ◽  
Cooperative Study ◽  
Clinical Drug Trials ◽  
Global Impression Of Change ◽  
Clinical Drug

It is important that clinicians who rate global change as part of Alzheimer's disease (AD) clinical drug trials agree on a relevant set of behaviors and information to be considered in formulating their rating. Yet, consensus among raters has been difficult to establish, and inter-rater reliability of clinical global impression of change (CGIC) ratings has been low. In preparation for the development of a new CGIC scale to be used in AD clinical trials, the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC), we surveyed clinicians at sites comprising the National Institute on Aging-sponsored ADCS participating centers to identify whether or not consensus regarding CGICs exists. Overall, respondents reported that a CGIC should include an assessment of the patient's function and mental status, a care giver interview, and a standardized set of questions, and it should take approximately 20 minutes per interview. Depending on a patient's level of impairment, raters consider different areas of behavior in formulating a CGIC rating. These findings demonstrate the considerable consensus regarding the CGIC rating process, and were integrated into the design of the ADCS-CGIC, currently in use.

Assessment of Motor and Process Skills as a Measure of IADL Functioning in Pharmacologic Studies of People With Alzheimer's Disease: A Pilot Study

1997 ◽  
Vol 9 (2) ◽  
pp. 197-206 ◽  
Author(s):  
Frances Oakley ◽  
Trey Sunderland
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Motor Skills ◽  
Daily Living ◽  
Outcome Measure ◽  
Process Skills ◽  
Drug Trials ◽  
Double Blind ◽  
Significant Difference

The purpose of this pilot study was to evaluate the usefulness of the Assessment of Motor and Process Skills (AMPS) as an outcome measure of instrumental activities of daily living (IADL) in pharmacologic studies of people with Alzheimer's disease. The AMPS simultaneously measures motor and process skills and their effect on the ability of the person to perform familiar IADL tasks. We administered the AMPS to 11 Alzheimer inpatients in a 31/2-month, double-blind, placebo-controlled, crossover study of fluoxetine and selegiline administered as single agents and in combination with physostigmine. Results indicated that there was a significant difference in IADL ability among study conditions for process skills, but not for motor skills, thereby suggesting that the AMPS is useful as a sensitive outcome measure of IADL ability in drug trials with this population.

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