PK, PD, safety and tolerability of CNP520 in healthy elderly subjects
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CNP520 in healthy elderly subjects
IRAS ID
182533
Contact name
Annelize Koch
Contact email
Sponsor organisation
Novartis
Eudract number
2013-005576-18
Duration of Study in the UK
0 years, 7 months, 21 days
Research summary
CNP520 is being developed by the Sponsor, Novartis for the treatment of Alzheimer’s disease.
Alzheimer’s disease causes progressive mental deterioration that can occur in middle or old age. The mental deterioration is caused by generalized degeneration of the brain. It is the most common cause of premature senility.
About 125 healthy, elderly subjects (aged 60 to 80 years) will join in this study at approximately 10 centers worldwide (e.g. USA, UK, Belgium, Netherlands and Germany). The subjects will be randomized to one of 5 treatment groups with approximately 25 subjects per treatment group.
The primary purpose of this study is to determine the safety of CNP520 over 3 months to allow initiation of long term clinical studies in patients who are at high risk of developing Alzheimer’s Disease (AD). In addition, this study is expected to allow for selecting the most appropriate dose of CNP520 in future clinical studies.
Safety, pharmacokinetic (PK) and pharmacodynamics (PD) assessments will be performed during the study. Safety assessments will include physical examinations, ECGs, vital signs, standard clinical laboratory evaluations (hematology, blood chemistry, urinalysis), Neurological examination, Cognitive assessments, Visual Field Test and Best corrected Visual acuity assessments, dermatological assessments, adverse event and serious adverse event monitoring.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0357
Date of REC Opinion
12 Aug 2015
REC opinion
Further Information Favourable Opinion