Effects of CST-103 on Cerebral Perfusion & Cognition
Research type
Research Study
Full title
A Single Blind, Placebo-Controlled, Randomized, 2-Way, 3-Period Crossover Study to Measure Cerebral Perfusion and Cognition After Weekly Oral Administration of CST-103 in Healthy Volunteers and Subjects with Mild Cognitive Impairment or Parkinson’s Disease.
IRAS ID
285308
Contact name
Judy Reynolds
Contact email
Sponsor organisation
CuraSen Therapeutics Inc.
Eudract number
2020-002466-14
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
The purpose of this study is to test a drug called CST-103 that is being developed for the treatment of Parkinson’s disease (PD) and Mild Cognitive Impairment (MCI).
PD is a condition in which cells that produce a chemical called dopamine in parts of the brain stop working properly and are lost over time, leading to damage of those parts of the brain progressively over many years. Symptoms start to appear when the brain can’t make enough dopamine to control movement properly.
Alzheimer’s disease (AD) is a severe neurodegenerative disorder affecting approximately 44 million people worldwide. Therefore, there is an urgent need for developing therapeutic agents capable of simultaneously addressing cognitive symptoms and pathology of AD and its precursor, MCI.
The nonclinical data on β-AR (Beta-adrenoceptor) agonists, neuroanatomical data showing that the locus coeruleus is one of the first areas affected in neurodegeneration, and pharmacoepidemiology data all support the potential for β-AR agonists as a class to have a significant role in the therapy of a variety of neurodegenerative diseases, including AD and PD. Results from CuraSen’s 3 previous clinical studies provided data that demonstrated a dose-dependent increase in cerebral perfusion, positive cognitive effects, and a good tolerability profile for CST-103.
There is currently no cure for Parkinson’s or Alzheimer’s disease, but current medications can help control the symptoms. The study drug is being developed in the hope of providing new treatments.
This study will be conducted at a single-site in London. 12 volunteers and 16 subjects with MCI or PD will be enrolled in this study. The study duration will be approximately 7 weeks, including a Screening period of up to 21 days, and three treatment periods, and an End of Study assessment.
All subjects will complete neuroimaging, cognitive, clinical, laboratory, and pharmacodynamic assessments during each treatment period.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
20/EE/0185
Date of REC Opinion
4 Aug 2020
REC opinion
Unfavourable Opinion