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Clinical Trials/NCT01023685
NCT01023685CompletedPhase 2

An Open-label Extension to a 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in Patients With Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106.

Novartis16 sites in 1 country24 target enrollmentStarted: December 1, 2009Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Novartis
Enrollment
24
Locations
16
Primary Endpoint
Safety/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients who have completed the core study with no significant safety concerns

Exclusion Criteria

  • •Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression).
  • •Diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease.
  • •Diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation.
  • •Other protocol-defined inclusion/exclusion criteria may apply

Outcomes

Primary Outcomes

Safety/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66.

Time Frame: 66 weeks

Secondary Outcomes

  • Immune response, cognitive and functional assessments at multiple time points including but not limited to baseline, and through to the end of the study to week 66.(66 weeks)
  • Collect long-term safety information through SAE's collection for two years after completion of the extension study.(2 years)
  • Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study.(66 weeks)

Investigators

Sponsor
Novartis
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (16)

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