Saturday, March 09, 2019 8:43:02 AM
Now, considering the past performance of such academic (do not bite the hand that feeds you) exercises; what are the chances that AVXL trials get recognized/supported?
Alzheimer's disease (AD) remains one of greatest unmet medical needs in our country with estimates of over 5 million Americans suffering from the disease in 2016 with no new symptomatic therapies having been approved over the past 12 years, and currently no approved disease-modifying agents. The timeframe, complexity, and expense of the recruitment process and site activation for AD trials are extremely challenging, and indeed trial enrollment and site network development represent a bottleneck for drug development for the AD field; there is a growing consensus that we must fundamentally overhaul the current clinical trial recruitment and assessment structure. This proposal aims aim to create an optimized infrastructure to optimally design, efficiently launch, rapidly recruit with improved diversity, and successfully complete NIH supported clinical trials in AD and related dementias.
http://grantome.com/grant/NIH/U24-AG057437-02
This ACTC will provide expertise and infrastructure to design and conduct trials across the full continuum of AD, from primary prevention initiatives to combination trials for advanced symptomatic stages. We also stand ready to collaborate on trials in other age- related dementias, leveraging the experience of the NeuroNext team at Harvard and other expert investigators in vascular and non-AD neurodegenerative diseases. We will build on our successes with public/private partnerships and continue to strengthen our strategic alliances to conduct large scale trials, but will also focus on supporting novel approaches to smaller investigator-initiated POC studies that will better inform Phase 3 decision-making. Finally, we will provide training and leadership opportunities to young clinical investigators to facilitate continued innovation in trial design, and catalyze the next generation of AD clinical trials.
Public Health Relevance
Alzheimer's disease (AD) remains one of greatest unmet medical needs in our country with estimates of over 5 million Americans suffering from the disease in 2016 with no new symptomatic therapies having been approved over the past 12 years, and currently no approved disease-modifying agents. The timeframe, complexity, and expense of the recruitment process and site activation for AD trials are extremely challenging, and indeed trial enrollment and site network development represent a bottleneck for drug development for the AD field; there is a growing consensus that we must fundamentally overhaul the current clinical trial recruitment and assessment structure. This proposal aims aim to create an optimized infrastructure to optimally design, efficiently launch, rapidly recruit with improved diversity, and successfully complete NIH supported clinical trials in AD and related dementias.
http://grantome.com/grant/NIH/U24-AG057437-02S1
Why do they continue to ignore obvious benefit and utility of technology like ERP? For example? They are their own worst enemy. IMO, these people represent the (ESTBALISHMENT-RESPONSIBLE FOR THE HOLE ARE IN).
Recent AVXL News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/22/2026 12:15:26 PM
- Anavex Life Sciences Receives Expected Nasdaq Delinquency Notification • GlobeNewswire Inc. • 05/22/2026 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2026 08:15:25 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 05/14/2026 08:15:30 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 05/11/2026 08:30:22 PM
- CEO Transition and Delayed SEC Filing Put Anavex (AVXL) Leadership Changes in Focus • IH Market News • 05/06/2026 02:52:36 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2026 11:04:59 AM
- Anavex Life Sciences Board of Directors Appoints Former Senior Vice President of Clinical Development Terrie Kellmeyer, PhD, as Interim Chief Executive Officer • GlobeNewswire Inc. • 05/06/2026 11:00:00 AM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 05/01/2026 11:18:47 PM
- Anavex Life Sciences Highlights New Scientific Findings on Shared Biology Between Autism and Alzheimer’s Disease • GlobeNewswire Inc. • 04/14/2026 11:30:00 AM
- Anavex Life Sciences to Present at the 25th Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 04/07/2026 11:30:00 AM
- Anavex withdraws EU approval filing for Alzheimer’s therapy • IH Market News • 03/30/2026 12:39:26 PM
- Anavex Life Sciences Provides Comprehensive Regulatory Update • GlobeNewswire Inc. • 03/30/2026 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/25/2026 08:06:00 PM
- Anavex withdraws EU marketing application for Alzheimer’s therapy blarcamesine • IH Market News • 03/25/2026 02:06:58 PM
- Anavex Life Sciences Provides Update on Regulatory Review in the EU for Blarcamesine to Treat Early Alzheimer’s Disease • GlobeNewswire Inc. • 03/25/2026 11:30:00 AM
- Anavex Life Sciences Presents New Data from its AD-004 Phase IIb/III Trial at AD/PD 2026 Conference Demonstrating Consistent Correlation Between the Treatment Effect of Oral Blarcamesine and Preservation of Brain Volume in Early Alzheimer’s Disease • GlobeNewswire Inc. • 03/23/2026 11:30:00 AM
- New Scientific Findings Highlight Hypothesis of Autophagy Failure as a Precursor of Amyloid Beta and Tau Pathology in Alzheimer’s Disease • GlobeNewswire Inc. • 03/20/2026 11:30:00 AM
- Anavex Life Sciences Presents Significant Treatment Effects of Blarcamesine in New Advanced Alpha-Synuclein Model of Parkinson’s Disease at AD/PD 2026 Conference • GlobeNewswire Inc. • 03/17/2026 11:30:00 AM
- Anavex Life Sciences to Present at the Citizens Life Sciences Conference • GlobeNewswire Inc. • 03/03/2026 12:30:00 PM
- Anavex Life Sciences to Present at the 46th TD Cowen Annual Health Care Conference • GlobeNewswire Inc. • 02/25/2026 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/25/2026 11:07:01 AM
- Anavex Life Sciences Appoints Seasoned Healthcare Leader to Board of Directors • GlobeNewswire Inc. • 02/23/2026 12:30:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/09/2026 09:40:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/09/2026 12:31:17 PM
