ClinicalTrials.Veeva

Menu

Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age

Novartis logo

Novartis

Status and phase

Completed
Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: Placebo
Drug: CNP520

Study type

Interventional

Funder types

Industry

Identifiers

NCT02576639
CCNP520X2102
2013-005576-18 (EudraCT Number)

Details and patient eligibility

About

The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in subsequent efficacy studies.

Enrollment

124 patients

Sex

All

Ages

60 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Healthy status
  • Body weight: ≥45kg
  • BMI: 18-34 kg/m2

Key Exclusion Criteria:

  • History or presence of any clinically significant disease of any major system organ class.
  • Heavy smoker status
  • History /presence of clinically significant neurological or psychiatric disorders
  • Any medical condition that might lead to or is associated with any cognitive deficit
  • History or presence of severely impaired renal function

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

124 participants in 5 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
Treatment:
Drug: Placebo
CNP520 2 mg
Experimental group
Description:
CNP520 2 mg was taken qd orally for 13 weeks.
Treatment:
Drug: CNP520
CNP520 10 mg
Experimental group
Description:
CNP520 10 mg was taken qd orally for 13 weeks.
Treatment:
Drug: CNP520
CNP520 35 mg
Experimental group
Description:
CNP520 35 mg was taken qd orally for 13 weeks.
Treatment:
Drug: CNP520
CNP520 85 mg
Experimental group
Description:
CNP520 85 mg was taken qd orally for 13 weeks.
Treatment:
Drug: CNP520

Trial contacts and locations

11

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems