Publications by authors named "P A Ardayfio"

Article Synopsis
  • The study aimed to evaluate the effectiveness and side effects of donanemab, an antibody targeting amyloid plaques in the brains of Alzheimer's patients, as current treatment options are limited.
  • The research involved a large-scale, 18-month clinical trial with 1736 participants diagnosed with early symptomatic Alzheimer disease, conducted across 277 medical centers in 8 countries from June 2020 to April 2023.
  • Results showed that out of 24 assessed outcomes, 23 indicated significant improvement, with the donanemab group demonstrating a notable decrease in cognitive impairment compared to the placebo group over the 76-week period.
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Introduction: PRESENCE was a phase 2 clinical trial assessing the efficacy of mevidalen, a D1 receptor positive allosteric modulator, for symptomatic treatment of Lewy body dementia (LBD). Mevidalen demonstrated improvements in motor and non-motor features of LBD, global functioning, and actigraphy-measured activity and daytime sleep. Adverse events (AEs) of fall were numerically increased in mevidalen-treated participants.

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Article Synopsis
  • * The study analyzed how the drug's levels in the body relate to its ability to reduce plaques and cause imaging abnormalities, revealing that certain factors like body weight influence donanemab exposure but not its effectiveness.
  • * Maintaining a specific concentration of donanemab in the bloodstream is linked to plaque reduction, with most participants clearing amyloid plaques by 52 weeks; however, individuals with the apolipoprotein ε4 variant face a higher risk of side effects.
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Background: Mevidalen is a selective positive allosteric modulator (PAM) of the dopamine D1 receptor subtype.

Objective: To assess the safety and efficacy of mevidalen for treatment of cognition in patients with Lewy body dementia (LBD).

Methods: PRESENCE was a phase 2, 12-week study in participants with LBD (N = 344) randomly assigned (1:1:1:1) to daily doses of mevidalen (10, 30, or 75 mg) or placebo.

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Background: Lasmiditan (LTN) is a selective 5-HT receptor agonist for the acute treatment of migraine in adults. We present detailed safety findings from the placebo-controlled, double-blind Phase 3 study, of LTN treatment across 4 attacks (CENTURION).

Methods: Patients were randomized 1:1:1 to LTN 200 mg (LTN200), LTN100, or a control group that received placebo for 3 attacks and LTN50 for either the 3rd or 4th attack (1:1).

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