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Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.

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ClinicalTrials.gov Identifier: NCT00733863
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : May 12, 2010
Sponsor:
Information provided by:
Novartis

Study Description
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Brief Summary:
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mild Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Biological: Placebo Biological: CAD106 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106
Study Start Date : July 2008
Actual Primary Completion Date : February 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Biological: CAD106
Placebo Comparator: 2 Biological: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52. [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through the end of the study to Week 52. [ Time Frame: 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Mild Alzheimer's Disease
  • Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks

Exclusion Criteria:

  • Previously participated in an AD vaccine study and received active treatment
  • History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
  • History or presence of seizures and/or cerebrovascular disease.
  • Presence of an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733863


Locations
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France
Centre Hospitalier Universitaire Pellegrin
Bordeaux, France
Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden
Switzerland
NeuroPsychologieZentrum
Basel, Switzerland
United Kingdom
Moorgreen Hospital
Southampton, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
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Principal Investigator: Novartis Pharmaceuticals Novartis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00733863     History of Changes
Other Study ID Numbers: CCAD106A2201
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: May 12, 2010
Last Verified: May 2010

Keywords provided by Novartis:
Active immunization
Alzheimer disease
Antibody
 Central Nervous System Diseases
Neurodegenerative diseases
Vaccine

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders