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Key considerations for combination therapy in Alzheimer's clinical trials: Perspectives from an expert advisory board convened by the Alzheimer's drug discovery foundation.
J Prev Alzheimers Dis
January 2025
Alzheimer's Drug Discovery Foundation, New York, NY, USA. Electronic address:
There is growing consensus in the Alzheimer's community that combination therapy will be needed to maximize therapeutic benefits through the course of the disease. However, combination therapy raises complex questions and decisions for study sponsors, from preclinical research through clinical trial design to regulatory, statistical, and operational considerations. In January 2024, the Alzheimer's Drug Discovery Foundation convened an expert advisory board to discuss the key considerations in each of these areas.
View Article and Find Full Text PDFBlarcamesine for the treatment of Early Alzheimer's Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial.
J Prev Alzheimers Dis
January 2025
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA. Electronic address:
Background: There are no approved oral disease-modifying treatments for Alzheimer's disease (AD).
Objectives: The objective of this study was to assess efficacy and safety of blarcamesine (ANAVEX®2-73), an orally available small-molecule activator of the sigma-1 receptor (SIGMAR1) in early AD through restoration of cellular homeostasis including autophagy enhancement.
Design: ANAVEX2-73-AD-004 was a randomized, double-blind, placebo-controlled, 48-week Phase IIb/III trial.
Molecular biomarkers of glial activation and injury in epilepsy.
Drug Discov Today
January 2025
Faculty of Engineering and Science, University of Greenwich London, Chatham Maritime, ME4 4TB, UK; Faculty of Medicine, Tbilisi State University, Tbilisi 0179, Georgia. Electronic address:
Increasing evidence from fluid biopsies suggests activation and injury of glial cells in epilepsy. The prevalence of clinical and subclinical seizures in neurodegenerative conditions such as Alzheimer's disease, frontotemporal dementia, and others merits review and comparison of the effects of seizures on glial markers in epilepsy and neurodegenerative diseases with concomitant seizures. Herein, we revisit preclinical and clinical reports of alterations in glial proteins in cerebrospinal fluid and blood associated with various types of epilepsy.
View Article and Find Full Text PDFEnhancing the effect of rehabilitation on multiple sclerosis: A randomized clinical trial investigating the impact of remotely-supervised transcranial direct current stimulation and virtual reality telerehabilitation training.
Mult Scler Relat Disord
December 2024
IRCCS Fondazione Don Carlo Gnocchi ONLUS, Milan, Italy. Electronic address:
Background: Multiple sclerosis (MS) is a demyelinating disease characterized by balance and gait impairment, fatigue, anxiety, depression, and diminished quality of life. Transcranial direct current stimulation (tDCS) has emerged as an effective intervention for managing these symptoms.
Objective: This study aims to investigate the efficacy of remotely supervised tDCS (RS-tDCS) applied to the left dorsolateral prefrontal cortex, in conjunction with a telerehabilitation (TR) program, on motor (balance and gait), cognitive (executive functions), and participation outcomes (fatigue, anxiety, depression, and quality of life) in persons with MS (pwMS).
Utilizing natural language processing to identify pediatric patients experiencing status epilepticus.
Seizure
January 2025
Division of Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Harvard Medical School, 300 Longwood Ave, Boston, MA 02115, USA.
Purpose: Compare the identification of patients with established status epilepticus (ESE) and refractory status epilepticus (RSE) in electronic health records (EHR) using human review versus natural language processing (NLP) assisted review.
Methods: We reviewed EHRs of patients aged 1 month to 21 years from Boston Children's Hospital (BCH). We included all patients with convulsive ESE or RSE during admission.
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