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Full-Text Articles in Medicine and Health Sciences
Intepirdine As Adjunctive Therapy To Donepezil For Mild-To-Moderate Alzheimer’S Disease: A Randomized, Placebo-Controlled, Phase 3 Clinical Trial (Mindset), Frederick M. Lang, Yi Mo, Marwan Sabbagh, Paul Solomon, Merce Boada, Roy W. Jones, Giovanni B. Frisoni, Timo Grimmer, Bruno Dubois, Mark Harnett, Sarah R. Friedhoff, Shari Coslett, Jeffrey L. Cummings
Intepirdine As Adjunctive Therapy To Donepezil For Mild-To-Moderate Alzheimer’S Disease: A Randomized, Placebo-Controlled, Phase 3 Clinical Trial (Mindset), Frederick M. Lang, Yi Mo, Marwan Sabbagh, Paul Solomon, Merce Boada, Roy W. Jones, Giovanni B. Frisoni, Timo Grimmer, Bruno Dubois, Mark Harnett, Sarah R. Friedhoff, Shari Coslett, Jeffrey L. Cummings
Brain Health Faculty Publications
Introduction: A previous phase 2b study supported the use of the 5-HT6 receptor antagonist intepirdine as adjunctive therapy to donepezil for Alzheimer's disease (AD) dementia. A phase 3 study, MINDSET, was performed to test this hypothesis. Methods: MINDSET was a global, double-blind, randomized, placebo-controlled trial in 1315 mild-to-moderate AD dementia patients on stable donepezil. Patients received 35 mg/day intepirdine or placebo for 24 weeks. The co-primary endpoints were change from baseline to week 24 on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL). Results: There were no statistically significant differences between intepirdine …
The “Rights” Of Precision Drug Development For Alzheimer’S Disease, Jeffrey Cummings, Howard H. Feldman, Philip Scheltens
The “Rights” Of Precision Drug Development For Alzheimer’S Disease, Jeffrey Cummings, Howard H. Feldman, Philip Scheltens
School of Medicine Faculty Publications
There is a high rate of failure in Alzheimer’s disease (AD) drug development with 99% of trials showing no drug-placebo difference. This low rate of success delays new treatments for patients and discourages investment in AD drug development. Studies across drug development programs in multiple disorders have identified important strategies for decreasing the risk and increasing the likelihood of success in drug development programs. These experiences provide guidance for the optimization of AD drug development. The “rights” of AD drug development include the right target, right drug, right biomarker, right participant, and right trial. The right target identifies the appropriate …
Further Analyses Of The Safety Of Verubecestat In The Phase 3 Epoch Trial Of Mild-To-Moderate Alzheimer’S Disease, Michael F. Egan, Yuki Mukai, Tiffini Voss, James Kost, Julie Stone, Christine Furtek, Erin Mahoney, Jeffrey L. Cummings, Pierre N. Tariot, Paul S. Aisen, Bruno Vellas, Christopher Lines, David Michaelson
Further Analyses Of The Safety Of Verubecestat In The Phase 3 Epoch Trial Of Mild-To-Moderate Alzheimer’S Disease, Michael F. Egan, Yuki Mukai, Tiffini Voss, James Kost, Julie Stone, Christine Furtek, Erin Mahoney, Jeffrey L. Cummings, Pierre N. Tariot, Paul S. Aisen, Bruno Vellas, Christopher Lines, David Michaelson
Integrated Health Sciences Faculty Publications
Background: Verubecestat, a BACE1 inhibitor that reduces Aβ levels in the cerebrospinal fluid of humans, was not effective in a phase 3 trial (EPOCH) of mild-to-moderate AD and was associated with adverse events. To assist in the development of BACE1 inhibitors, we report detailed safety findings from EPOCH. Methods: EPOCH was a randomized, double-blind, placebo-controlled 78-week trial evaluating verubecestat 12 mg and 40 mg in participants with mild-to-moderate AD diagnosed clinically. The trial was terminated due to futility close to its scheduled completion. Of 1957 participants who were randomized and took treatment, 652 were assigned to verubecestat 12 mg, 652 …
Efficacy Of A Dissolvable Strip With Calcium Sodium Phosphosilicate (Novamin®) In Providing Rapid Dentine Hypersensitivity Relief, John Gallob, Martin R. Ling, Pejmon Amini, Avinash Patil, Mounir Atassi
Efficacy Of A Dissolvable Strip With Calcium Sodium Phosphosilicate (Novamin®) In Providing Rapid Dentine Hypersensitivity Relief, John Gallob, Martin R. Ling, Pejmon Amini, Avinash Patil, Mounir Atassi
Dental Medicine Faculty Publications
Objective To evaluate the efficacy of a dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) (Novamin®) in providing rapid relief from dentine hypersensitivity (DH). Methods In this examiner-blind, proof-of-principle study, 120 healthy adults with DH were randomized 1:1 to the Test strip, professionally applied to facial surfaces of two selected teeth, or to No treatment. Sensitivity was assessed at baseline and 10 min, 2 h and 4 h post-application in response to evaporative (air) and tactile stimuli (measured by Schiff sensitivity scale/a numeric rating scale and tactile threshold, respectively). Change from baseline was analyzed by ANCOVA. Results At 10 …