Cognitive and Functional Differences in Parkinson, FDA Lifts Hold on IkT-148009, Solanezumab Shows No Impact on Cognitive Decline

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Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Using prospective cohort studies of community-dwelling elders followed up to 20 years, findings published in Neurology identified specific cognitive and functional declines in patients who developed incident Parkinson disease (PD). There were important sex differences as well, as men with incident PD had a steeper decline in executive function compared with women, but only women with incident PD exhibited detectably faster prediagnostic decline in global cognition. Between those with and without incident PD, the rates of global cognition decline between at year 5 for men and year 10 for women. Among both sexes, the level and rate of decline in executive function started to diverge at year 5, though for women there was no difference at subsequent time points. Sex differences in slopes emerged at 5 years prior to diagnosis for global cognition and 15 years prior to diagnosis for executive function.

According to a recent announcement, the FDA has lifted its clinical hold on IkT-148009 (Inhibikase Therapeutics) in multiple system atrophy (MSA), allowing for the company to proceed with its phase 2a “202” clinical trial. The news comes less than 2 months after the agency lifted a clinical hold on program assessing the agent in Parkinson disease. At the time, the agency requested further evaluation of the existing safety and pharmacokinetic data of the 200 mg dose, a better understanding of how the trials will monitor adverse events that could affect vision in trial participants, and the need for material additions to the disclosures made to investigators and patients related to the clinical and safety measures completed to that point, including the potential vision risks. MSA is a rare form of Parkinsonism, which occurs in a different part of the brain and advances 3 times faster than ordinary PD.

Newly announced findings from the phase 3 Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease (A4) study showed that solanezumab, an investigational agent developed by Eli Lilly, showed no effect on slowing of the progression of cognitive decline in patients with preclinical Alzheimer disease (AD). Launched in 2013, the A4 study was a first-of-its-kind secondary progression trial, enrolling more than 1100 individuals between 65 and 85 years of age who had PET imaging evidence of amyloid plaque accumulation in the brain. Over the course of approximately 4.5 years, the agent did not statistically differ from placebo on the primary outcome of Preclinical Alzheimer Cognitive Composite. Solanezumab is a humanized monoclonal IgG1 antibody directed against the mid-domain of the amyloid-ß peptide. It recognizes soluble monomeric, not fibrillar, amyloid-ß.

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