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21 Diseases |  |
6 Trials |
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6 Trials |  |
141 News |  |
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- ||| azeliragon (TTP488) / Cantex Pharma
Enrollment closed, Phase classification, Enrollment change: Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance (clinicaltrials.gov) - Dec 19, 2020
P2, N=43, Active, not recruiting, Sponsor: vTv Therapeutics
Recruiting --> Active, not recruiting | Phase classification: P2/3 --> P2 | N=300 --> 43
- azeliragon (TTP488) / vTv Therapeutics
[VIRTUAL] THE AZELIRAGON ELEVAGE STUDY: STUDY UPDATE AND PRELIMINARY DATA ON BASELINE CHARACTERISTICS OF PARTICIPANTS WITH MILD ALZHEIMER’S DISEASE AND TYPE 2 DIABETES RANDOMIZED IN PART 1 () - Oct 9, 2020 - Abstract #CTAD2020CTAD_203;
P2/3
Part 1 of the Elevage study is enrolling subjects aged 50-85 years with probable mild AD (Screening MMSE 21-26, CDR global 0.5-1, ADAScog 14 ≥10) and T2D (HbA1c 6.5%-9.5%) receiving stable acetylcholinesterase inhibitors and/or memantine. Baseline characteristics of the blinded Elevage study population will be presented and descriptively compared with the baseline characteristics of the hypothesis- generating T2D subgroup from the STEADFAST Study.
- | azeliragon (TTP488) / vTv Therapeutics
Journal: High mobility group box 1 protein regulates osteoclastogenesis through direct actions on osteocytes and osteoclasts in vitro. (Pubmed Central) - Sep 17, 2020
In bone marrow macrophages (BMMs), toll-like receptor 4 (TLR4) inhibition with LPS-RS, but not receptor for advanced glycation end products (RAGE) inhibition with Azeliragon attenuated osteoclast differentiation...Our findings also suggest that increased osteoclastogenesis induced by apoptotic osteocytes CM is not mediated through HMGB1/RAGE activation and that direct HMGB1 actions in osteocytes stimulate pro-osteoclastogenic signal release from Cx43 osteocytes. Based on these findings, we propose that HMGB1 exerts dual effects on osteoclasts, directly by inducing differentiation through TLR4 and RAGE activation and indirectly by increasing pro-osteoclastogenic cytokine secretion from osteocytes.
- azeliragon (TTP488) / vTv Therapeutics, memantine / Generic mfg.
[VIRTUAL] Effects of azeliragon on ADAS-cog and CDR domains and individual items in patients with mild Alzheimer's disease and type 2 diabetes (T2D) () - Aug 2, 2020 - Abstract #AAIC2020AAIC_3369;
STEADFAST was a randomized, double-blind, placebo-controlled trial in 875 patients with probable mild AD (MMSE 21-26, CDR global 0.5-1) receiving stable acetylcholinesterase inhibitors and/or memantine, evaluating the efficacy and safety of 18 months of treatment with azeliragon 5 mg/day relative to placebo. Results suggest that azeliragon may have benefits over placebo with less decline in memory, language, and praxis over 18 months in patients with mild AD and T2D.
- | azeliragon (TTP488) / vTv Therapeutics
Journal: Assessment of Azeliragon QTc Liability Through Integrated, Model-Based Concentration QTc Analysis. (Pubmed Central) - Jul 31, 2020
Model-based analysis showed a small, nonclinically meaningful, positive relationship between azeliragon plasma concentration and QTcF with a slope close to zero. Neither the prediction interval nor the upper bound of the 90% confidence interval reached 10 milliseconds, demonstrating no clinically meaningful drug-related effect on QTcF at expected therapeutic and supratherapeutic doses of azeliragon.
- | azeliragon (TTP488) / vTv Therapeutics
Preclinical, Journal: Short-term pharmacologic RAGE inhibition differentially effects bone and skeletal muscle in middle-aged mice. (Pubmed Central) - Jul 31, 2020
Interestingly, while Azeliragon induced similar metabolic changes in bone and skeletal muscle, aging differentially altered the expression of genes associated with glucose uptake/metabolism in these two tissues, highlighting a potential explanation for the differential effects of Azeliragon on bone and skeletal muscle in middle-aged mice. Overall, our findings suggest that while short-term pharmacologic RAGE inhibition did not protect against early aging-induced bone alterations, it prevented against the early effects of aging in skeletal muscle.
- | azeliragon (TTP488) / vTv Therapeutics
Journal: Development of Azeliragon, an Oral Small Molecule Antagonist of the Receptor for Advanced Glycation Endproducts, for the Potential Slowing of Loss of Cognition in Mild Alzheimer's Disease. (Pubmed Central) - Dec 21, 2019
Based on promising results from the Phase 2b study, a Phase 3 registration program (STEADFAST) is being conducted under a Special Protocol Assessment from FDA. The ongoing Phase 3 program, if successful may demonstrate azeliragon can slow cognitive decline in mild AD patients.
- azeliragon (TTP488) / vTv Therapeutics
ACTIVATED CHOLANGIOCYTES RELEASE MACROPHAGE-POLARIZING EXTRACELLULAR VESICLES BEARING THE DAMP S100A11 (Hynes Convention Center, Hall B) - Sep 29, 2019 - Abstract #AASLD2019AASLD_2998;
Activated cholangiocytes release EVs containing the DAMP S100A11, which promotes inflammation and fibrosis via engagement of the RAGE pathway in macrophages. We speculate that RAGE inhibitors maybe salutary in cholestatic liver injury with abundant macrophage infiltration such as PSC.
- | azeliragon (TTP488) / vTv Therapeutics
Journal: Uremic Advanced Glycation End Products and Protein-Bound Solutes Induce Endothelial Dysfunction Through Suppression of Krüppel-Like Factor 2. (Pubmed Central) - Sep 28, 2019
We speculate that RAGE inhibitors maybe salutary in cholestatic liver injury with abundant macrophage infiltration such as PSC. These data identify KLF2 suppression as a consequence of the uremic milieu, which may exacerbate endothelial dysfunction and resultant cardiovascular disease.
- |||||| azeliragon (TTP488) / Cantex Pharma
Enrollment open: Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance (clinicaltrials.gov) - Jul 1, 2019
P2/3, N=300, Recruiting, Sponsor: vTv Therapeutics
These data identify KLF2 suppression as a consequence of the uremic milieu, which may exacerbate endothelial dysfunction and resultant cardiovascular disease. Not yet recruiting --> Recruiting
- |||||||||| azeliragon (TTP488) / Cantex Pharma
New P2/3 trial: Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance (clinicaltrials.gov) - Jun 12, 2019
P2/3, N=300, Not yet recruiting, Sponsor: vTv Therapeutics
- | azeliragon (TTP488) / Cantex Pharma
Trial termination: 2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension) (clinicaltrials.gov) - Jun 8, 2018
P3, N=298, Terminated, Sponsor: vTv Therapeutics
Not yet recruiting --> Recruiting Suspended --> Terminated; Not due to safety but due to a lack of efficacy at the 5 mg azeliragon dose.
- | azeliragon (TTP488) / Cantex Pharma
Trial termination: STEADFAST: Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - Jun 8, 2018
P3, N=880, Terminated, Sponsor: vTv Therapeutics
Suspended --> Terminated; Not due to safety but due to a lack of efficacy at the 5 mg azeliragon dose. Suspended --> Terminated; Not due to safety but due to a lack of efficacy at the 5 mg azeliragon dose.
- ||||||||| azeliragon (TTP488) / Cantex Pharma
Enrollment change, Trial completion date, Trial suspension, Trial primary completion date: 2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension) (clinicaltrials.gov) - May 3, 2018
P3, N=298, Suspended, Sponsor: vTv Therapeutics
Suspended --> Terminated; Not due to safety but due to a lack of efficacy at the 5 mg azeliragon dose. N=640 --> 298 | Trial completion date: Nov 2020 --> Jun 2018 | Enrolling by invitation --> Suspended | Trial primary completion date: Nov 2020 --> May 2018
- ||||||||| azeliragon (TTP488) / Cantex Pharma
Trial completion date, Trial suspension, Trial primary completion date: STEADFAST: Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - May 3, 2018
P3, N=880, Suspended, Sponsor: vTv Therapeutics
N=640 --> 298 | Trial completion date: Nov 2020 --> Jun 2018 | Enrolling by invitation --> Suspended | Trial primary completion date: Nov 2020 --> May 2018 Trial completion date: Jan 2019 --> Jun 2018 | Active, not recruiting --> Suspended | Trial primary completion date: Nov 2018 --> May 2018
- ||||| azeliragon (TTP488) / Cantex Pharma
Enrollment closed: STEADFAST: Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - Jun 1, 2017
P3, N=800, Active, not recruiting, Sponsor: vTv Therapeutics
Trial completion date: Jan 2019 --> Jun 2018 | Active, not recruiting --> Suspended | Trial primary completion date: Nov 2018 --> May 2018 Recruiting --> Active, not recruiting
- |||||| azeliragon (TTP488) / Cantex Pharma
Enrollment open: 2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension) (clinicaltrials.gov) - Jan 4, 2017
P3, N=640, Enrolling by invitation, Sponsor: vTv Therapeutics
Recruiting --> Active, not recruiting Not yet recruiting --> Enrolling by invitation
- |||| azeliragon (TTP488) / Cantex Pharma
Trial primary completion date: 2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension) (clinicaltrials.gov) - Nov 18, 2016
P3, N=640, Not yet recruiting, Sponsor: vTv Therapeutics
Not yet recruiting --> Enrolling by invitation Trial primary completion date: Jun 2019 --> Nov 2020
- |||| azeliragon (TTP488) / Cantex Pharma
Trial primary completion date: STEADFAST: Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - Nov 18, 2016
P3, N=800, Recruiting, Sponsor: vTv Therapeutics
Trial primary completion date: Jun 2019 --> Nov 2020 Trial primary completion date: Mar 2018 --> Nov 2018
- |||||||||| azeliragon (TTP488) / Cantex Pharma
New P3 trial: 2-Year Extension Study of Azeliragon in Subjects With Alzheimer's Disease (STEADFAST Extension) (clinicaltrials.gov) - Sep 27, 2016
P3, N=640, Not yet recruiting, Sponsor: vTv Therapeutics
- | azeliragon (TTP488) / Cantex Pharma
Enrollment open: STEADFAST: Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - Apr 29, 2015
P3, N=800, Recruiting, Sponsor: TransTech Pharma, LLC.
Trial primary completion date: Mar 2018 --> Nov 2018 Not yet recruiting --> Recruiting
- | azeliragon (TTP488) / Cantex Pharma
Trial initiation date, Trial primary completion date: STEADFAST: Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - Apr 14, 2015
P3, N=800, Not yet recruiting, Sponsor: TransTech Pharma, LLC.
Not yet recruiting --> Recruiting Initiation date: Dec 2014 --> Apr 2015 | Trial primary completion date: Jul 2017 --> Mar 2018
- |||| azeliragon (TTP488) / Cantex Pharma
Trial primary completion date: STEADFAST: Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - Jul 4, 2014
P3, N=800, Not yet recruiting, Sponsor: TransTech Pharma
Initiation date: Dec 2014 --> Apr 2015 | Trial primary completion date: Jul 2017 --> Mar 2018 Trial primary completion date: Mar 2017 --> Jul 2017
- ||||| azeliragon (TTP488) / Cantex Pharma
Trial initiation date, Trial primary completion date: STEADFAST: Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - Jul 4, 2014
P3, N=800, Not yet recruiting, Sponsor: TransTech Pharma
Trial primary completion date: Mar 2017 --> Jul 2017 Initiation date: Jun 2014 --> Dec 2014 | Trial primary completion date: Mar 2017 --> Jul 2017
- |||||||||| azeliragon (TTP488) / Cantex Pharma
New P3 trial: STEADFAST: Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - Mar 4, 2014
P3, N=800, Not yet recruiting, Sponsor: TransTech Pharma