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Background: CT1812 is an experimental therapeutic sigma-2 receptor modulator in development for Alzheimer's disease (AD) and dementia with Lewy bodies. CT1812 reduces the affinity of Aβ oligomers to bind to neurons and exert synaptotoxic effects. This phase 2, multi-center, international, randomized, double-blind, placebo-controlled trial assessed safety, tolerability and effects of CT1812 on cognitive function in individuals with AD.
View Article and Find Full Text PDFBackground: Selecting the optimal dose for clinical development is especially problematic for drugs directed at CNS-specific targets. For drugs with a novel mechanism of action, these problems are often greater. We describe Xanamem's clinical pharmacology, including the approach to dose selection and proof-of-concept studies.
View Article and Find Full Text PDFBackground: Alzheimer's disease (AD) is characterized by progressive atrophy of the cerebral cortex and hippocampus, with concomitant increase in ventricular volume. Lomecel-B is a novel cell-based therapeutic approach to AD that targets neuroinflammation, microvascular dysfunction, and has the potential to stimulate endogenous tissue regeneration. We conducted MRI analysis of brain morphology in the CLEAR-MIND study, a 49-patient proof-of-concept study that tested 3 different dosing regimens of Lomecel-B vs placebo in patients with mild AD dementia.
View Article and Find Full Text PDFDrug Development.
Alzheimers Dement
December 2024
Burke Neurological Institute, Weill Cornell Medicine, White Plains, NY, USA.
Background: Benfotiamine, a prodrug of thiamine, raises blood levels by 50-100 times to achieve pharmacologic effects. It provides a novel therapeutic direction addressing a well-characterized brain tissue thiamine deficiency and related changes in glucose metabolism in AD. BenfoTeam is a seamless phase 2A-2B "proof of concept" (POC), double-blind, placebo-controlled RCT investigating tolerability, safety, and efficacy of benfotiamine, as a first-in-class small molecule treatment for early AD.
View Article and Find Full Text PDFBackground: Lomecel-B is a novel cell-based therapy with potential to demonstrate clinical benefit on Alzheimer's disease (AD) and its progression. Here we present the results of a phase 2a proof-of-concept trial (n = 49) to further define the potential of Lomecel-B in patients with mild AD dementia.
Methods: This double-blind, randomized, placebo-controlled 45-week trial (ClinicalTrials.
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