An overview of the latest news in Parkinson disease reported across MJH Life Sciences™.
An overview of the latest news in Parkinson disease (PD) reported across MJH Life Sciences™.
FDA Approves Investigational NDA for Ketamine in Levodopa-Induced Dykinesia
As the gold standard of treatment for PD, levodopa effectively reduces parkinsonian symptoms, although long-term use has been linked with several adverse events. Chief among these, frequency of OFF time and abnormal involuntary movements, known as levodopa-induced dyskinesia (LID), have been shown to significantly impact quality of life and treatment efficacy.
There are no approved treatments to address LID; however, an article by NeurologyLive® indicates there may be some progress in addressing this issue. Last week, the FDA approved PharmaTher Holdings’ investigational new drug application (NDA) for ketamine, an N-methyl-D-aspartate (NMDA) receptor-modulating drug, in the treatment of LID in patients with PD.
A phase 2 clinical trial evaluating the safety, efficacy, and pharmacokinetics of ketamine compared with the active control treatment of midazolam is expected to begin patient enrollment in the third quarter of this year. Pending success, the manufacturer noted that it will seek an agreement with the FDA to proceed to a phase 3 clinical study next year.
Novel Treatment Associated With Cognition Improvement in PD, Alzheimer Disease
According to recently published interim results from an ongoing phase 2a clinical trial of ANVS401, an investigational therapy intended to halt the production of abnormal protein aggregates in the brain, the treatment was associated with statistically significant improvement in cognition as measured by the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11).
As reported by NeurologyLive®, study participants with PD (n = 14) or Alzheimer disease (AD; n = 14) who completed biomarker analysis showed a statistically significant 4.4-point improvement (30%) on the ADAS-Cog11 (P = .04) after 25 days of ANVS401 treatment. Compared with placebo, a 3.3-point improvement (20%) on the ADAS-Cog11 was also observed (P = .13).
The announcement marks ANVS401 as the first treatment examined in a double-blind, placebo-controlled study to demonstrate cognitive improvements in patients with AD using ADAS-Cog11 and functional improvements in patients with PD as measured by the Movement Disorder Society - Unified Parkinson’s Disease Rating Scale. Researchers will further assess different doses of the investigational therapy among 40 participants to determine the optimal dose.
Neurological Disease Link With COVID-19 Severity, Death
In assessing risk for worse COVID-19 disease severity and death, results of a study reported by NeurologyLive® finds that several neurological diseases may serve as independent risk factors.
Collecting data from COVID-19–positive (n = 1167) and COVID-19–negative (n = 11,696) individuals from UK Biobank, risk factors identified as significant after being evaluated via stepwise model regression included AD (odds ratio [OR[, 5.700; 95% CI, 3.709-8.762; P < .001), PD (OR, 2.242; 95% CI, 1.511-3.328; P <.001), and other forms of dementia (OR, 3.412; 95% CI, 2.234-5.213; P < .001).
Furthermore, univariable analysis that used death as a dependent variable showed that all-cause dementia (OR, 2.171; 95% CI, 1.231-3.900; P = .008) and AD (OR, 2.766; 95% CI, 1.123-7.420; P = .032) were associated with higher risk of COVID-19–related death independent of age. African ethnicity was also found to be associated with higher risk of death in COVID-19–positive inpatients.