clinical_trial   86

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Basic, Translational and Clinical Research: What the heck is the difference and how do I pick one?
> Many physicians are doing translational research! Translational research is for curious individuals who are equally eager to apply knowledge in the design of a new therapy. These individuals often are pragmatic, less concerned with theory and more with result. Oftentimes, translational research will overlap with fields of engineering and pharmacology. Doing translational research can provide promise of something that can potentially be game-changing in medicine and is highly appealing for that reason. Many people also are enticed by going through the extensive process that requires screening, validation and ultimate application of therapies to humans. In many ways, translational research is all about this process. However, be warned: very, very few therapies actually make it to humans!
research  clinical_trial  translational 
12 days ago by porejide
Betterhumans | Our Projects
Non-profit apparently running a trial on senolytics. > Senolytic Compounds: The question seeking to be answered by this Phase 0 pilot study is whether the senolytic compounds Dasatinib (CAS no. 302962-48-8) and Quercetin (CAS no. 117-39-5) will significantly eliminate senescent cells contained in the muscle and fat tissue of elderly individuals who have Metabolic Syndrome and/or Osteoarthritis, and will reduce levels of systemic inflammation, insulin resistance, improve their immunological responses, and in those having Osteoarthritis, reverse the progression of this disease.
senolytic  betterhumans  transhumanism  clinical_trial  aging 
march 2018 by porejide
FDA OKs Cognition as Sole Outcome Measure for Preclinical AD Trials | ALZFORUM
> “[The guidance] reflects acceptance of new approaches that are supported by research. … The acknowledgement that large effects in cognition may be important without a co-primary was refreshing,” ... The new guidance does not use the term “disease-modifying,” but instead suggests looking for an effect on disease progression by using a crossover design, in which the placebo group switches to active drug at a given point in time. If the placebo group fails to catch up to the benefit seen in the active group, this indicates a lasting effect of the treatment on the course of disease. The FDA emphasized that this benefit must be shown on clinical tests, not just on biomarkers.
alzheimers  FDA  cognition  clinical_trial 
march 2018 by porejide
Impact of Photobiomodulation (PBM) on Biomarkers of Alzheimer's Disease - Full Text View - ClinicalTrials.gov
> Photobiomodulation (PBM) describes the use of near-infrared light (which is not visible to the eye) to heal and protect tissue that has either been injured, is degenerating, or else is at risk of dying. Research suggests that the light delivered during PBM enhances the body's biochemical ability to store and use energy and increase blood flow, which triggers the body's natural healing processes. The goal of this study is to determine if PBM administered transcranially (through the scalp and skull) and intranasally (inside the nose) has an effect on cognitive function and behavioral symptoms in people with Alzheimer's disease (AD). The study will also examine whether PBM has an effect on biomarkers of AD in the blood and spinal fluid of patients with AD. A biomarker is a specific physical trait used to measure the progress of a disease or condition.
alzheimers  clinical_trial 
january 2018 by porejide
Peter Thiel: Bet on Magic Mushrooms For Treating Depression Is Coming | Fortune
> Giving patients drugs that are based on the active ingredient in magic mushrooms, known for their hallucinogenic properties, could help reboot the brains of people who suffer from mental illness and who are otherwise resistant to treatment. That company, Compass Pathways, said on Wednesday that it plans to start clinical trials of its drug starting in the first three months of 2018. The tests, to be conducted in partnership with Worldwide Clinical Trials, will be conducted in a number of European countries including Germany, Finland, the Netherlands, Spain, and the United Kingdom. “We need a new approach to tackling mental health,” George Goldsmith, executive chairman and co-founder of Compass Pathways, said in a statement
peter_thiel  psilocybin  psychiatry  clinical_trial 
january 2018 by porejide
Federal Right-to-Try Legislation — Threatening the FDA’s Public Health Mission — NEJM
> The bill passed by the Senate and sent to the House has three key provisions. First, it would enable a patient with a life-threatening disease to obtain an unapproved drug after phase 1 testing, as long as a physician in good standing certifies that the patient has exhausted approved treatment options and is unable to participate in a trial of the desired drug. Access would require a willing prescriber, the manufacturer’s agreement, and the patient’s or surrogate’s informed consent. Signoff from the FDA — which currently checks for adequate evidence of safety and efficacy to support the proposed use and affirms that providing access will not interfere with clinical trials — would no longer be required.4
FDA  clinical_trial  2018 
january 2018 by porejide
RIP: Serotonin Receptor 5-HT6 Antagonist | ALZFORUM
> Any last hopes for serotonin receptor 6-targeted cognitive enhancers ran into cold reality this week, with the publication of results from three failed Phase 3 trials of the 5-HT6 antagonist idalopirdine. In the January 8 JAMA, Alireza Atri of California Pacific Medical Center in San Francisco and colleagues present the wholly negative findings of the STARSHINE, STARBEAM, and STARBRIGHT trials. The program, involving 2,525 people with mild to moderate Alzheimer’s disease in hundreds of centers in 34 countries, came to naught when idalopirdine at any dose failed to produce improvement in cognitive symptoms over placebo.
idalopiridine  alzheimers  phase3  clinical_trial  serotonin 
january 2018 by porejide
At Least We Know These Don’t Work: Negative Trials at CTAD | ALZFORUM
> “Safety was good but we had no efficacy on cognition or function,” Pueyo said. The drug did get into the CSF and increased glutamate in the brain, Pueyo said in response to audience questions, but still achieved none of the desired benefit. Curiously, symptoms of depression improved in both drug and placebo groups, perhaps as a consequence of receiving the added care and attention that come with participating in a clinical trial.
depression  alzheimers  clinical_trial 
december 2017 by porejide
Tissue-independent cancer drug gets fast-track approval from US regulator : Nature News & Comment
> The new approval, announced on 23 May, expands the use of a drug called pembrolizumab, manufactured by pharmaceutical giant Merck & Co. of Kenilworth, New Jersey. The drug fosters the immune system’s attack on tumours by blocking a protein called PD-1, which normally holds the immune system in check. The FDA had previously approved pembrolizumab for use in several cancers, including lung and skin cancer. But physicians can now use pembrolizumab in any solid tumour that has a particular defect in its ability to repair damaged DNA.
oncology  cancer  clinical_trial  fda  2017 
may 2017 by porejide
Patients Lose Sight After Stem Cells Are Injected Into Their Eyes - The New York Times
> The women had macular degeneration, an eye disease that causes vision loss, and they paid $5,000 each to receive stem-cell injections in 2015 at a private clinic in Sunrise, Fla. The clinic was part of a company then called Bioheart, now called U.S. Stem Cell. Staff members there used liposuction to suck fat out of the women’s bellies, and then extracted stem cells from the fat to inject into the women’s eyes.
fda  clinical_trial  blindness  2017  stem_cells 
march 2017 by porejide
RHR: Prevention and Treatment of Alzheimer’s from a Functional Perspective—With Dr. Dale Bredesen
> And the IRBs in Australia, both the public and the private, turned it down, and they said, “This is too complicated.” They said, “Obviously you don’t understand how to do a clinical trial because you’re trying to change more than one variable.” And we said, “Obviously you don’t understand how Alzheimer’s disease works, because it’s not a one-variable disease.” Just recently a group in Sydney now has come back and said, “Well, maybe we can try to run this through again.” Surprisingly, the very physicians who were on the IRBs that turned it down turned around and said to us, “Can we use it anyway in our own practices?” So it’s kind of a bizarre situation where we’re so set up with this classic idea of doing single-variable clinical trials. We have to break out of that and look at the approach of multivariable trials.
clinical_trial  alzheimers  apoe 
march 2017 by porejide
Guess How This Latest Alzheimer’s Trial Came Out | In the Pipeline
BACE inhibitor, a big phase III trial in AD, reports negative results.
alzheimers  bace  clinical_trial 
february 2017 by porejide
Northumbria University 'life-threatening' caffeine test fine - BBC News
> The students had volunteered to take part in a test in March 2015 aimed at measuring the effect of caffeine on exercise.
They were given 30g of caffeine instead of 0.3g, Mr Farrer said.
Death had previously been reported after consumption of just 18g, he told the court.
The university had switched from using caffeine tablets to powder, he said.
caffeine  overdose  drugs  clinical_trial 
january 2017 by porejide
At 2nd Kloster Seeon Meeting, Renewed Optimism for Targeting BACE1 | ALZFORUM
> “Academics tend to overstate findings because they want to get papers in the best journals. This should stop immediately,” he said. Budd noted that if even one paper reports a potential side effect, then drug sponsors are obliged to test for it even if subsequent reports don’t bear out the original report. “This can increase the cost of trials, because unless you have proven [the side effect] is not in humans, you have to take that one publication into account. Toxicity tests do not stop with animal models, it continues all the way through the clinic,” she said.
bace  alzheimers  clinical_trial  toxicity 
october 2016 by porejide
OT55: Thready For Hillary | Slate Star Codex
> The publications committee discussed target journals, and recommended that the paper be submitted to the American Journal of Psychiatry as a Brief Report. The rationale for this was the following: … As a Brief Report, we feel we can avoid mentioning the lack of statistically significant positive effects at week 8 or study termination for secondary endpoints
psychiatry  clinical_trial 
august 2016 by porejide
The amyloid hypothesis of Alzheimer's disease at 25 years - Selkoe - 2016 - EMBO Molecular Medicine - Wiley Online Library
> Success breeds success, and it appears increasingly likely that exciting progress in the clinic, building upon a 3-decade record of advances in the laboratory, will provide this proof. The continued push toward a safe and efficacious amyloid therapeutic takes nothing away from the need for alternative agents that target other early features of this complex and devastating syndrome. As others have pointed out (Small & Duff, 2008; De Strooper & Karran, 2016) and we concur, after disease initiation, the complexity of the downstream pathogenic processes increases.
amyloid  hypothesis  alzheimers  clinical_trial 
march 2016 by porejide
Will Death in French Drug Trial Lead to Tighter Phase 1 Rules? | ALZFORUM
> The protocol also gave chemists their first look at the structure of BIA 10-2474. Companies commonly hide the identities of investigational drugs under code names, and bury the drug structures in patents among hundreds of variations on the same compound. Scientists have previously complained about the difficulties this practice causes for curation, drug repurposing, and analysis of potential drug interactions
clinical_trial  chemistry  drugs 
january 2016 by porejide
A New, Life-or-Death Approach to Funding Heart Research - The New York Times
> “If you subject a person to the risks and hassles of being in a clinical trial, there is an implicit promise that they are giving to science,” he said. “Giving to science means the results get published.”
science  clinical_trial  heart_disease 
november 2015 by porejide
Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease - Full Text View - ClinicalTrials.gov
> CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people. Fifty patients with mild to moderate Alzheimer's disease will participate in this study.
gene_therapy  alzheimers  clinical_trial 
may 2013 by porejide

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