* PD Effects of CST-103/CST-107 on CNS in Neurodegenerative Disorders
Research type
Research Study
Full title
A Phase II, Randomized, Placebo-Controlled, Double-Blind, Crossover, Study of the Pharmacodynamic Effects of CST-103 co-administered with CST-107 on the Central Nervous System in Subjects with Neurodegenerative Disorders
IRAS ID
294318
Contact name
Aliya Asher
Contact email
Sponsor organisation
CuraSen Therapeutics, Inc.
Eudract number
2020-006067-28
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
The purpose of this study is to test two drugs - CST-103 (a Beta-adrenoceptor (β-AR) agonist given with CST-107 (a Beta blocker) that are being investigated for the treatment of neurodegenerative disorders. CST-103 given with CST-107 will be compared to matching placebo (dummy tablet) in this study.
The objective is to identify an improvement in cognition eg. in learning, thinking, and remembering, after multiple oral doses of CST-103 /CST-107 in four populations of subjects with neurodegenerative disorders. This includes patients with Parkinson's Disease with sleep disorders, Mild Cognitive Impairment (MCI), Parkinson’s Disease Dementia (PDD) and Dementia with Lewy Bodies (DLB). Protein deposits, called Lewy bodies, develop in nerve cells in the brain regions involved in thinking, memory and movement (motor control). Lewy body dementia causes a progressive decline in mental ability.
By improving blood flow in and out of the brain in areas that are affected in these disorders, there may be a positive effect on clinical symptoms such as memory and cognition.
At present, there are no drugs that can cure or even slow down the progression of neurodegenerative conditions such as Parkinson’s and Dementia with Lewy Bodies.
This study will be conducted at 3 MAC sites (Lancashire, South Yorkshire and Greater Manchester). The study involves 2 Cohorts aiming to recruit approximately 40 subjects (20 subjects in Cohort A with Parkinson’s with sleep disorders or Mild Cognitive Impairment and 20 subjects in Cohort B with Parkinson’s Disease Dementia or Dementia with Lewy Bodies). They will be enrolled in a 2 period, 2-way cross over design following study eligibility confirmation during the screening period. The treatment period is 14 days. Each treatment period will be separated by a washout period of 14 days (+5-day window).All patients will complete clinical and pharmacodynamic assessments during each treatment period along with cognitive tests, and an after study follow up visit.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0151
Date of REC Opinion
1 Apr 2021
REC opinion
Further Information Favourable Opinion