Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients
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ClinicalTrials.gov Identifier: NCT01097096 |
Recruitment Status
:
Completed
First Posted
: April 1, 2010
Last Update Posted
: April 25, 2016
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
Tracking Information | ||||
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First Submitted Date ICMJE | March 29, 2010 | |||
First Posted Date ICMJE | April 1, 2010 | |||
Last Update Posted Date | April 25, 2016 | |||
Study Start Date ICMJE | March 2010 | |||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Safety and tolerability assessments (physical/neurological examinations, electrocardiogram (ECG), vital signs, standard and special laboratory evaluations, Magnetic Resonance Imaging (MRIs), Adverse events / Serious adverse events (AE/SAE) monitoring). [ Time Frame: Screening and through the end of the study to Week 90 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01097096 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients | |||
Official Title ICMJE | A 90-week, Multi-center, Randomized, Double-blind, Placebo-controlled Study in Patients With Mild Alzheimer's Disease (AD) to Investigate the Safety, Tolerability and Abeta-specific Antibody Response Following Repeated i.m. Injections of Adjuvanted CAD106 | |||
Brief Summary | This study will assess the safety, tolerability and Abeta-specific antibody response of repeated intra-muscular injections of adjuvanted CAD106 in patients with mild Alzheimer's Disease. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Alzheimer's Disease | |||
Intervention ICMJE | Biological: CAD106 | |||
Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
177 | |||
Original Estimated Enrollment ICMJE |
120 | |||
Actual Study Completion Date | December 2012 | |||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply |
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Sex/Gender |
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Ages | up to 85 Years (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Canada, Germany, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United States | |||
Removed Location Countries | Turkey | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01097096 | |||
Other Study ID Numbers ICMJE | CCAD106A2203 2009-012394-35 ( EudraCT Number ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Novartis ( Novartis Pharmaceuticals ) | |||
Study Sponsor ICMJE | Novartis Pharmaceuticals | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Novartis | |||
Verification Date | March 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |