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Clinical Trial News

Brain+ Initiates Clinical Trial of BrainBlossom for Mild Cognitive Impairment

• Brain+ has commenced a clinical trial to evaluate BrainBlossom, a next-generation cognitive training technology, for individuals with Mild Cognitive Impairment (MCI). • The randomized, controlled trial will assess the feasibility and impact of BrainBlossom in 40 participants with MCI over a four-week, at-home training program. • Expected results in early 2025 will determine the next steps, including a larger clinical trial for regulatory data and potential pharmaceutical partnerships. • BrainBlossom builds upon validated cognitive training methods and aims to provide scalable, home-based therapeutic delivery for the large MCI population.

Crestone's CRS3123 Shows Promise in Phase 2 Trial for C. difficile Infection

  • Crestone's CRS3123 demonstrated comparable clinical cure rates to vancomycin in treating Clostridioides difficile infection (CDI) in a Phase 2 trial.
  • The study revealed significantly lower CDI recurrence rates with CRS3123 compared to vancomycin at day 40 (4% vs. 23%).
  • CRS3123 was well-tolerated, with no serious treatment-emergent adverse events reported during the clinical trial.
  • NIAID exercised its option to provide $4.5 million in new funding for microbiome analyses and manufacturing process optimization of CRS3123.

National Clinical Trial Investigates Benfotiamine for Early Alzheimer's Disease

  • A nationwide Phase 2A-2B clinical trial, named BenfoTeam, is underway to assess benfotiamine, a synthetic form of vitamin B1, for treating mild cognitive impairment and early Alzheimer's disease.
  • The trial, spanning 50 sites across the U.S., aims to determine if benfotiamine improves cognitive function in individuals aged 50-89 with mild Alzheimer's or mild cognitive impairment.
  • Benfotiamine increases blood thiamine levels significantly, potentially addressing thiamine deficiencies observed in the brains of Alzheimer's patients, and is administered orally, unlike some other treatments.
  • The BenfoTeam trial seeks to enroll 406 participants and will last 18 months, with the goal of providing a cost-effective and accessible treatment option for diverse patient populations.

A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

NCT06223360RecruitingPhase 2
Alzheimer's Disease Cooperative Study (ADCS)
Posted 3/28/2024

UK Takes Bold Step to Ban Xylazine and 21 Other Substances in Major Drug Control Initiative

  • The UK government has introduced legislation to ban xylazine, known as the "zombie drug," and 21 other substances as part of efforts to combat drug-related deaths and disrupt criminal gangs.
  • Six substances, including new variants of nitazenes which are more potent than heroin, will be classified as Class A drugs, carrying potential life imprisonment sentences for production or distribution.
  • The legislative changes, following Advisory Council recommendations, are expected to be implemented by early 2025, positioning the UK ahead of other nations like the US and Canada in controlling xylazine abuse.

Hoth Therapeutics' HT-001 Shows Promise in Treating EGFRI-Associated Skin Toxicities

  • Hoth Therapeutics reports positive data from a human case study using HT-001 to treat EGFR inhibitor-associated papulopustular eruptions (PPEs).
  • A metastatic breast cancer patient experienced rapid symptom improvement after one week of HT-001 treatment, leading to treatment cessation.
  • The patient showed no new lesion development in the three weeks following treatment, suggesting HT-001's potential efficacy and safety.
  • A Phase 2a clinical trial is underway to further evaluate HT-001's efficacy and safety in managing EGFRI-associated skin toxicities.

Blinatumomab Improves Survival in Pediatric High-Risk B-ALL Post-Transplant

A recent study highlights the benefits of using blinatumomab as a third consolidation course before allogeneic hematopoietic stem cell transplantation (alloHSCT) in pediatric patients with high-risk, first-relapse B-cell acute lymphoblastic leukemia (B-ALL). The study found that blinatumomab significantly improves overall and event-free survival compared to standard chemotherapy, regardless of the conditioning regimen used.

Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)

NCT02393859CompletedPhase 3
Amgen
Posted 11/10/2015

Evommune's EVO756 Enters Phase 2 Trial for Chronic Inducible Urticaria

  • Evommune has initiated a Phase 2 clinical trial for EVO756, a novel oral therapy targeting chronic inducible urticaria (CIndU).
  • The trial will evaluate EVO756's safety and efficacy in approximately 30 patients with symptomatic dermographism or cold urticaria across 15 US sites.
  • EVO756, a selective MRGPRX2 antagonist, aims to reduce mast cell degranulation and alleviate symptoms by blocking this receptor.
  • The company anticipates launching a Phase 2b trial for chronic spontaneous urticaria (CSU) in the second quarter of 2025, expanding EVO756's clinical development.

Semaglutide Investigated for Diabetes, Obesity in Spinal Cord Injury Patients

  • A clinical trial is underway to investigate the mechanisms behind diabetes and obesity in individuals with spinal cord injuries.
  • The study will assess the safety and efficacy of semaglutide, a GLP-1 receptor agonist, in treating these metabolic conditions in this population.
  • Researchers aim to understand how semaglutide impacts glucose tolerance, insulin action, and body composition in patients with spinal cord injury.
  • The trial seeks to address the lack of research and treatment guidelines for diabetes and obesity in this high-risk population.

Emapalumab Enhances Intervention-Free Survival in Pediatric HLH Patients Undergoing Stem Cell Transplant

  • A new study shows that emapalumab improves outcomes for children with hemophagocytic lymphohistiocytosis (HLH) undergoing stem cell transplantation.
  • Emapalumab treatment was associated with a lower incidence of mixed chimerism and severe mixed chimerism post-transplant.
  • The study found that 73% of children treated with emapalumab achieved intervention-free survival, compared to 43% without the treatment.
  • Infants, who are at higher risk, showed even more significant improvement in intervention-free survival with emapalumab treatment.

MOST Trial: Anti-Clotting Drugs Fail to Improve Outcomes in Stroke Patients

  • The MOST trial investigated the efficacy of adding argatroban or eptifibatide to intravenous thrombolysis for stroke patients to prevent further clots.
  • Results indicated that neither argatroban nor eptifibatide improved patient outcomes and had a less than 1% probability of being helpful.
  • The study, conducted across 57 U.S. sites, found that these drugs were linked to greater incidences of disability and mortality within three months post-treatment.
  • Researchers emphasize that negative trials like MOST are crucial for informing future research and developing new anticoagulant treatments for stroke.

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