scholarly journals Subgroup analyses of the amyloid PET substudies from EMERGE and ENGAGE, phase 3 clinical trials evaluating aducanumab in patients with early Alzheimer’s disease

2021 ◽  
Vol 17 (S9) ◽  
Author(s):  
Raj Rajagovindan ◽  
Tianle Chen ◽  
Hao Wu ◽  
Ying Tian ◽  
Laura Nisenbaum ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Amyloid Pet ◽  
Phase 3 ◽  
Subgroup Analyses ◽  
Early Alzheimer’S Disease

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).

O1-07-01: Diagnostic comparison of regional amyloid PET and different CSF biomarker assays for identifying early Alzheimer's disease

2015 ◽  
Vol 11 (7S_Part_3) ◽  
pp. P140-P140
Author(s):  
Sebastian Palmqvist ◽  
Henrik Zetterberg ◽  
Niklas Mattsson ◽  
Lennart Minthon ◽  
Kaj Blennow ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Amyloid Pet ◽  
Csf Biomarker ◽  
Early Alzheimer’S Disease

scholarly journals Correction to: Amyloid PET, FDG-PET or MRI? - the power of different imaging biomarkers to detect progression of early Alzheimer’s disease

BMC Neurology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Marion Ortner ◽  
René Drost ◽  
Dennis Hedderich ◽  
Oliver Goldhardt ◽  
Felix Müller-Sarnowski ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Fdg Pet ◽  
Imaging Biomarkers ◽  
Amyloid Pet ◽  
Early Alzheimer’S Disease

scholarly journals Emerge and Engage topline results: Phase 3 studies of aducanumab in early Alzheimer’s disease

2020 ◽  
Vol 16 (S9) ◽  
Author(s):  
Samantha Budd Haeberlein ◽  
Christian von Hehn ◽  
Ying Tian ◽  
Spyros Chalkias ◽  
Kumar Kandadi Muralidharan ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Phase 3 ◽  
Early Alzheimer’S Disease

P4-178: RATER QUALIFICATIONS IN EARLY ALZHEIMER'S DISEASE CLINICAL TRIALS

2014 ◽  
Vol 10 ◽  
pp. P854-P854
Author(s):  
Macarena García-Valdecasas Colell ◽  
Julie Marsh ◽  
Jan Sedway
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Early Alzheimer’S Disease

scholarly journals AUTHORS RESPONSE TO UMBRICHT D, LETTER TO THE EDITOR REFERRING FUTILITY ANALYSES IN ALZHEIMER’S DISEASE (AD) CLINICAL TRIALS: A RISKY BUSINESS. THE JOURNAL OF PREVENTION OF ALZHEIMER’S DISEASE, 2020

2020 ◽  
pp. 1-1
Author(s):  
P.S. Aisen ◽  
R. Raman
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Treatment Effect ◽  
Phase 3 ◽  
Letter To The Editor ◽  
Full Analysis ◽  
Risky Business

Dr. Umbricht suggests that the two examples we cite in our viewpoint (1) support rather than call into question the value of interim futility analyses in Alzheimer’s disease (AD) trials. He points out that the first example, the Phase 3 trials of aducanumab, the futility analyses did indeed indicate a trend toward a beneficial treatment effect in one of the two trials though the planned pooled futility decision led to stopping the trials. In the second case, in which a futility analysis led to a halt, full analysis of available data suggested efficacy; a subsequent study was negative.

scholarly journals Automatic Prediction of Cognitive and Functional Decline Can Significantly Decrease the Number of Subjects Required for Clinical Trials in Early Alzheimer’s Disease

2021 ◽  
pp. 1-8
Author(s):  
Neda Shafiee ◽  
Mahsa Dadar ◽  
Simon Ducharme ◽  
D. Louis Collins ◽  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Cognitive Decline ◽  
Functional Decline ◽  
Amyloid Β ◽  
Cognitive Test ◽  
Disease Heterogeneity ◽  
Early Alzheimer’S Disease

Background: While both cognitive and magnetic resonance imaging (MRI) data has been used to predict progression in Alzheimer’s disease, heterogeneity between patients makes it challenging to predict the rate of cognitive and functional decline for individual subjects. Objective: To investigate prognostic power of MRI-based biomarkers of medial temporal lobe atrophy and macroscopic tissue change to predict cognitive decline in individual patients in clinical trials of early Alzheimer’s disease. Methods: Data used in this study included 312 patients with mild cognitive impairment from the ADNI dataset with baseline MRI, cerebrospinal fluid amyloid-β, cognitive test scores, and a minimum of two-year follow-up information available. We built a prognostic model using baseline cognitive scores and MRI-based features to determine which subjects remain stable and which functionally decline over 2 and 3-year follow-up periods. Results: Combining both sets of features yields 77%accuracy (81%sensitivity and 75%specificity) to predict cognitive decline at 2 years (74%accuracy at 3 years with 75%sensitivity and 73%specificity). When used to select trial participants, this tool yields a 3.8-fold decrease in the required sample size for a 2-year study (2.8-fold decrease for a 3-year study) for a hypothesized 25%treatment effect to reduce cognitive decline. Conclusion: When used in clinical trials for cohort enrichment, this tool could accelerate development of new treatments by significantly increasing statistical power to detect differences in cognitive decline between arms. In addition, detection of future decline can help clinicians improve patient management strategies that will slow or delay symptom progression.

scholarly journals Plasmon-Activated Water Reduces Amyloid Burden and Improves Memory in Animals with Alzheimer’s Disease

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Chia-Hsiung Cheng ◽  
Kun-Ju Lin ◽  
Chien-Tai Hong ◽  
Dean Wu ◽  
Hung-Ming Chang ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Memory Performance ◽  
Memory Function ◽  
Amyloid Β ◽  
Amyloid Pet ◽  
Amyloid Burden ◽  
Daily Consumption ◽  
Innovative Strategy

Abstract With the great extension of the human lifespan in recent times, many aging diseases have inevitably followed. Dementia is one of the most-commom neurodegenerative aging diseases, in which inflammation-related Alzheimer’s disease (AD) is the most prevalent cause of dementia. Amyloid accumulation in the brain, which occurs before any clinical presentations, might be the first and key step in the development of AD. However, many clinical trials have attempted to remove amyloid from brains of AD patients, but none has so far been successful. Negatively charged plasmon-activated water (PAW) is created by resonantly illuminated gold (Au) nanoparticles (NPs), which reduce the hydrogen-bonded (HB) structure of water. PAW was found to possess anti-oxidative and anti-inflammatory effects. Herein, we report on an innovative strategy to retard the progression of AD by the daily consumption of PAW instead of normal deionized (DI) water. APPswe/PS1dE9 transgenic mice were treated with PAW or DI water from the age of 5 months for the next 9 months. Encouragingly, compared to DI water-treated mice, mice treated with PAW presented better memory performance on a test of novel object recognition and had a significantly lower amyloid burden according to 18F-florbetapir amyloid-PET and phosphorylated (p)-tau burden according to Western blotting and immunohistochemistry measurements. There were no obvious side effects in PAW-treated mice. Collectively, our findings support that PAW was able to reduce the amyloid and p-tau burden and improve memory in an AD mouse model. However, the protein levels of molecules involved in amyloid metabolism and oligomeric amyloid did not change. We propose that the effects of PAW of reducing the amyloid burden and improving memory function cannot be attributed to synthesis/degradation of amyloid-βprotein but probably in preventing aggregation of amyloid-β proteins or other mechanisms, including anti-inflammation. Further applications of PAW in clinical trials to prevent the progression of AD are being designed.

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