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

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

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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