Background: Intracerebral hemorrhage (ICH) is the most severe and disabling stroke, accounting for up to 50% of the cases in low-to-middle-income countries. High rates of cognitive decline and dementia follow acute ICH, due to the common underlying vasculopathy of cerebral small vessel disease (CSVD). The international clinical trial, TRIDENT (Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial), aims to determine the effectiveness of the fixed low-dose Triple Pill combination of blood pressure-lowering agents (telmisartan 20 mg, indapamide 1.25 mg, and amlodipine 2.5 mg) versus placebo on recurrent stroke and additionally on the secondary outcomes of cognitive decline and dementia. The aim of the Brazilian substudy is to assess the Triple Pill effectiveness on memory, cognition, and CSVD progression in ICH patients.
Method: This substudy is part of the TRIDENT international, multicenter, double-blind, placebo-controlled, parallel-group, randomized controlled trial led by The George Institute for Global Health in Australia. A subset of participants recruited from Brazilian local sites are offered the opportunity to undergo additional cognitive assessments through gold-standard neuropsychological tests at baseline (until up to 6 weeks post-randomization), and 12 months. MRI evaluation of these patients will be performed to assess CSVD progression through specific parameters at baseline and 12 months. Primary Outcome (MRI) - Changes in T2 FLAIR WMH volume between baseline and 12 months will be assessed. Secondary Outcomes (MRI) 1. Whole brain atrophy measured by percentage brain volume change between baseline and 12 months on HIRES-T1. 2. Substructure change (cortical grey matter, white matter, and CSF) between baseline and 12 months. 3. Change in the number of CMBs between baseline and 12 months on SWI.
Result: The study recruitment is ongoing.
Conclusion: The substudy could potentially evaluate Triple Pill's effectiveness on cognitive decline, dementia, and CSVC progression.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1002/alz.088874 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Evaluation of Safety and Efficacy of a Single Lorecivivint Injection in Patients with Knee Osteoarthritis: A Multicenter, Observational Extension Trial.
Rheumatol Ther
January 2025
Biosplice Therapeutics, Inc., 9360 Towne Centre Dr, San Diego, CA, 92121, USA.
Introduction: Lorecivivint (LOR), a CDC-like kinase/dual-specificity tyrosine kinase (CLK/DYRK) inhibitor thought to modulate inflammatory and Wnt pathways, is being developed as a potential intra-articular knee osteoarthritis (OA) treatment. The objective of this trial was to evaluate long-term safety of LOR within an observational extension of two phase 2 trials.
Methods: This 60-month, observational extension study (NCT02951026) of a 12-month phase 2a trial (NCT02536833) and 6-month phase 2b trial (NCT03122860) was administratively closed after 36 months as data inferences became limited.
Adjunctive PCSK9 Inhibitor Evolocumab in the Prevention of Early Neurological Deterioration in Non-cardiogenic Acute Ischemic Stroke: A Multicenter, Prospective, Randomized, Open-Label, Clinical Trial.
CNS Drugs
January 2025
Department of Cardiology, Second Affiliated Hospital of Dalian Medical University, Dalian, China.
Background: Early neurological deterioration (END) is associated with a poor prognosis in acute ischemic stroke (AIS). Effectively lowering low-density lipoprotein cholesterol (LDL-C) can improve the stability of atherosclerotic plaque and reduce post-stroke inflammation, which may be an effective means to lower the incidence of END. The objective of this study was to determine the preventive effects of evolocumab on END in patients with non-cardiogenic AIS.
View Article and Find Full Text PDFEffectiveness of dynamic neuromuscular stabilization training on strength, endurance, and flexibility in adults with intellectual disabilities, a randomized controlled trial.
Sci Rep
January 2025
Department of Sport Injuries and Corrective Exercises, Faculty of Physical Education and Sport Sciences, Shahid Bahonar University of Kerman, Kerman, Iran.
Individuals with intellectual disabilities (ID) often exhibit lower levels of physical fitness compared to the general population, including reduced strength, endurance, flexibility, and coordination. Dynamic neuromuscular stabilization (DNS) training can potentially improve the performance of adults with ID caused by weak motor skills due to a lack of desirable nerve growth during childhood and before puberty. Also, DNS training proposed to improve physical fitness in this population, but the effectiveness and durability of DNS training on specific fitness components have not been well-established.
View Article and Find Full Text PDFShort-Term Assessment of High-Sensitivity C-Reactive Protein (hs-CRP) Changes Following One Anastomosis Gastric Bypass (OAGB) in Patients with Obesity: A Prospective Cohort Study.
Obes Surg
January 2025
Department of Surgery, Minimally Invasive Surgery Research Center, Division of Minimally Invasive and Bariatric Surgery, School of Medicine, Rasool‑E Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.
Background: Obesity, characterized by excessive adipose tissue, is associated with chronic low-grade inflammation and elevated inflammatory markers such as high-sensitivity C-reactive protein (hs-CRP). This inflammation is linked to obesity-associated medical problems, including cardiovascular diseases. One anastomosis gastric bypass (OAGB) has emerged as an effective metabolic and bariatric surgical procedure to address severe obesity and its associated inflammatory state.
View Article and Find Full Text PDFEarly treatment discontinuation in patients with deficient mismatch repair or microsatellite instability high metastatic colorectal cancer receiving immune checkpoint inhibitors.
J Immunother Cancer
January 2025
Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Background: Immune checkpoint inhibitors (ICIs) are recommended to treat patients with deficient mismatch repair/microsatellite instability high (dMMR/MSI-H) metastatic colorectal cancer (mCRC). Pivotal trials have fixed a maximum ICI duration of 2 years, without a compelling rationale. A shorter treatment duration has the potential to improve patients' quality of life and reduce both toxicity and cost without compromising efficacy.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!