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Saturday, January 29, 2022 8:40:59 PM
TTTav66, Thank you so mucb!!!
Alzheimer Disease: Phase 2b/3 Study (NCT03790709) of Blarcamesine (Anavex Life Sciences)
By mid-2022, Anavex Life Sciences is expected to release topline results from its ongoing phase 2/3b study evaluating blarcamesine, formerly known as ANAVEX 2-73, in patients with AD. The double-blind, placebo-controlled, 48-week clinical study is using the Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL) subscales as primary end points to assess the impact of blarcamesine on cognitive and functional measurements.10
Participants are randomized 1:1:1 to 2 different blarcamesine doses or placebo. In June 2021, the company announced that it had exceeded the enrollment target of 450 participants. Blarcamesine, an orally available agent, will also be evaluated on sigma-1 receptor (SIGMAR1) gene expression, a prespecified medicine biomarker. In a previously completed phase 2a genome-wide search study (NCT02244541), this gene expression correlated with direct measures of clinical benefit, cognition, and activities of daily living and function. This was the first such search for biomarkers associated with therapeutic response in AD. All told, the findings from that study were the basis of testing of potential selection markers for the ongoing phase 2b/3 trial.
Christopher U. Missling, PhD
Data from the phase 2a study and its extension (NCT02756858), published in April 2020, showed a treatment effect on multiple biomarkers at the end of a 57-week period. Among them included mean plasma concentration of blarcamesine (slope Mini-Mental State Examination [MMSE]: P <.041), genomic variants SIGMAR p.Gln2Pro (MMSE: P <.039; ADCS-ADL: P <.063) and COMT p.Leu146fs (MMSE: P <.039; ADCS-ADL: P <.063), and baseline MMSE score (slope MMSE: P <.015).11
"A significant unmet need exists currently for Alzheimer disease patients worldwide given the lack of available adequate therapeutic interventions, and we are excited to have exceeded enrollment of this study for ANAVEX 2-73,” Christopher U. Missling, PhD, president and chief executive officer, Anavex, said in a statement in June 2021.10 “Given ANAVEX 2-73’s convenient oral route of administration we believe it has the potential to deliver broad clinical utility.”Blarcamesine has also shown positive benefit in treating Parkinson disease dementia, indicated by results from a proof-of-concept phase 2 study (NCT03774459). In that trial, the drug’s impact on increasing SIGMAR1 expression correlated significant with responses on primary and secondary end points.
https://www.neurologylive.com/view/5-clinical-trial-readouts-neurology-to-look-for-in-2022
Good luck and GOD bless,
Alzheimer Disease: Phase 2b/3 Study (NCT03790709) of Blarcamesine (Anavex Life Sciences)
By mid-2022, Anavex Life Sciences is expected to release topline results from its ongoing phase 2/3b study evaluating blarcamesine, formerly known as ANAVEX 2-73, in patients with AD. The double-blind, placebo-controlled, 48-week clinical study is using the Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL) subscales as primary end points to assess the impact of blarcamesine on cognitive and functional measurements.10
Participants are randomized 1:1:1 to 2 different blarcamesine doses or placebo. In June 2021, the company announced that it had exceeded the enrollment target of 450 participants. Blarcamesine, an orally available agent, will also be evaluated on sigma-1 receptor (SIGMAR1) gene expression, a prespecified medicine biomarker. In a previously completed phase 2a genome-wide search study (NCT02244541), this gene expression correlated with direct measures of clinical benefit, cognition, and activities of daily living and function. This was the first such search for biomarkers associated with therapeutic response in AD. All told, the findings from that study were the basis of testing of potential selection markers for the ongoing phase 2b/3 trial.
Christopher U. Missling, PhD
Data from the phase 2a study and its extension (NCT02756858), published in April 2020, showed a treatment effect on multiple biomarkers at the end of a 57-week period. Among them included mean plasma concentration of blarcamesine (slope Mini-Mental State Examination [MMSE]: P <.041), genomic variants SIGMAR p.Gln2Pro (MMSE: P <.039; ADCS-ADL: P <.063) and COMT p.Leu146fs (MMSE: P <.039; ADCS-ADL: P <.063), and baseline MMSE score (slope MMSE: P <.015).11
"A significant unmet need exists currently for Alzheimer disease patients worldwide given the lack of available adequate therapeutic interventions, and we are excited to have exceeded enrollment of this study for ANAVEX 2-73,” Christopher U. Missling, PhD, president and chief executive officer, Anavex, said in a statement in June 2021.10 “Given ANAVEX 2-73’s convenient oral route of administration we believe it has the potential to deliver broad clinical utility.”Blarcamesine has also shown positive benefit in treating Parkinson disease dementia, indicated by results from a proof-of-concept phase 2 study (NCT03774459). In that trial, the drug’s impact on increasing SIGMAR1 expression correlated significant with responses on primary and secondary end points.
https://www.neurologylive.com/view/5-clinical-trial-readouts-neurology-to-look-for-in-2022
Good luck and GOD bless,
