Plexrec...this is as close as I can find right now. regrets, not the video that was brilliantly done. this guy (Timo) thinks-presents and talks about multiple variable links like he mixing a salad...brilliant stuff.
BLARCAMESINE IN EARLY SYMPTOMATIC ALZHEIMER DISEASE PHASE 2B/3 RANDOMIZED CLINICAL TRIAL
Presenter
Timo Grimmer (Germany)
Lecture Time
09:10 - 09:25
Abstract
Aims
To assess in early Alzheimer’s disease (AD) patient’s efficacy and adverse events of blarcamesine
(ANAVEX®2-73), an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1) designed
to exert neuroprotection through restoration of cellular homeostasis.
Methods
ANAVEX®2-73-AD-004 48-week study was an international, double-blind, multicenter, placebo-controlled
Phase 2b/3 clinical study. 508 patients with AD were randomized to blarcamesine or placebo. The clinical
outcomes (primary, secondary, and exploratory) included ADAS-Cog13, ADCS-ADL, CDR-SB, and CGI-I,
which were analyzed using a mixed model for repeated measures (MMRM) and biomarkers from the A/T/N
spectrum, plasma Aß42/40 ratio and brain volume measured by MRI.
Results
The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48
weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226)
for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early AD.
In addition, validated biomarkers of amyloid beta pathology, plasma Aß42/40 ratio increased significantly (P
= 0.048), demonstrating strong anti-amyloid effects of blarcamesine in Alzheimer’s disease patients, while
MRI revealed significant reduction in brain volume loss, including whole brain (P = 0.0005), comparing
treatment to placebo.
anavex_mri.jpg
Conclusions
Among participants with early symptomatic AD, blarcamesine was generally safe, well tolerated and
significantly slowed clinical progression at 48 weeks, which is also corroborated by biomarkers from the
A/T/N spectrum, including plasma Aß42/40 ratio increase and reduction of brain atrophy in several key
regions of the brain measured by MRI.
ClinicalTrials.gov Identifier: NCT03790709.
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