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Completed

NCT Number: NCT00956410

To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients

This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CAD106

Biological

Primary outcomes

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

    Time frame: 66 weeks

Secondary outcomes

  1. Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through to the end of the study to week 66.

    Time frame: 66 weeks

  2. Evaluate the antibody response after 4 additional injections in the Extension study in patients initially treated with CAD106 in the Core study.

    Time frame: 66 weeks

  3. Collect long-term safety information through SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 11, 2009
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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