Effects of CST-103 & CST-139 on Cerebral Perfusion & Cognition
Research type
Research Study
Full title
An Open-Label Brain Imaging and Cognition Study to Determine Changes in Cerebral Perfusion and Cognition After Oral Administration of CST-103 or CST-139.
IRAS ID
288124
Contact name
Pui Man Leung
Contact email
Sponsor organisation
CuraSen Therapeutics Inc.
Eudract number
2020-003796-17
Duration of Study in the UK
0 years, 4 months, 25 days
Research summary
The purpose of this study is to test two drugs called CST-103 and CST-139, Beta-adrenoceptor (β-AR) agonists, that are being evaluated for the treatment of neurodegenerative diseases.
Parkinson’s disease (PD) is a condition in which cells that produce a chemical called dopamine in the brain stop working correctly. Symptoms appear when the brain can’t make enough dopamine to control movement properly.
Alzheimer’s disease (AD) is a severe neurodegenerative disorder. There is a need to develop therapeutic agents capable of addressing both cognitive symptoms and pathology of AD and it’s precursor, Mild Cognitive Impairment (MCI).
There is currently no cure for PD or AD. CST-103 and CST-139 are being evaluated in the hope of providing new treatments.
The nonclinical data on β-AR 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 to have a significant role in the therapy of neurodegenerative diseases. This supports evaluation of the effects of CST-103 and CST-139 in subjects, to measure whether they have increased cerebral perfusion and improved results in cognitive tests before moving into a proof-of-concept study. The hypothesis is that by improving cerebral perfusion in areas of the brain relevant to common symptoms found in PD and MCI, the administration of a β2-AR agonist will have a positive effect on clinically relevant symptoms such as memory and cognition.
This study will be conducted at one site in Manchester. Part A will enrol 12 healthy volunteers, the study duration will be approximately 4 weeks. Parts B and C will each enrol 10 patients with PD or MCI, the study duration will be approximately 5 and 6 weeks, respectively.
All subjects will complete neuroimaging, clinical, laboratory, and pharmacodynamic assessments. Subjects in Parts B & C will also complete cognitive tests.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0217
Date of REC Opinion
21 Oct 2020
REC opinion
Further Information Favourable Opinion