Phase 2
N=124
Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02576639 ↗Enrolled (actual)
124
Serious AEs
0.8%
Results posted
May 2017
Primary outcome: Primary: Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths — 18; 19; 22; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CNP520 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths |
18; 19; 22; 20; 18; 0 | — |
| SECONDARY Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations |
-2.34; -20.55; -62.48; -82.93; -89.5; -2.64 | — |
| SECONDARY Summary of Plasma PK Parameter: Cmax |
4.76; 21.3; 75.6; 163; 16.6; 81 | — |
| SECONDARY Summary of Plasma PK Parameter: AUCtau |
67.1; 278; 966; 2300; 313; 1500 | — |
| SECONDARY Summary of Plasma PK Parameter: Tmax |
2.5; 2.5; 2.5; 2.5; 2.5; 2.5 | — |
| SECONDARY Summary of Plasma PK Parameter: Tlag |
0.5; 0.5; 0.5; 0; 0; 0 | — |
| SECONDARY Summary of Plasma PK Parameter: T1/2 |
150; 155; 155; 160 | — |
| SECONDARY Summary of PK Parameter: CLss/F |
7620; 7380; 8460; 8220 | — |
| SECONDARY Summary of Plasma PK Parameter: Racc |
5.86; 5.33; 4.75; 5.02 | — |
| SECONDARY Summary of CSF PK Concentrations |
0; 0; 0; 0; 0.166; 1.07 | — |
| SECONDARY Area-under-plasma Concentration Time Curve up to Infinity (AUCinf) |
— | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) |
— | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02576639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.