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Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD)

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ClinicalTrials.gov Identifier: NCT00411580
Recruitment Status : Completed
First Posted : December 14, 2006
Last Update Posted : March 29, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:

This study will evaluate the safety and tolerability and Aß-specific antibody response of CAD106 in patients with mild to moderate Alzheimer's Disease.

Patients also had a 2 year follow-up to assess disease progression where no drug was administered.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Biological: CAD106 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 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, Time-lagged, Parallel Group Study in Patients With Mild to Moderate Alzheimer's Disease (AD) to Investigate the Safety, Tolerability and Aß-specific Antibody Response Following Three Subcutaneous Injections of CAD106
Study Start Date : June 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Tolerability/safety assessments (physical/neurol.exam., ECG, vital signs, standard and special immunological laboratory evaluations, MRIs, EEGs, AE/SAE monitoring). [ Time Frame: at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52. ]
  2. Antibody titers (IgM and IgM titers against amyloid and carrier protein). [ Time Frame: at multiple timepoints including but not limited to baseline and through the end of the study to Week 52 ]

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

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • males and/or females patients between 50 to 80 years of age (both inclusive).
  • female patients must be without childbearing potential (post-menopausal or surgically sterilized).
  • diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders, 4th edition).
  • mild to moderate AD as confirmed by Mini-Mental State Exam score of 16 to 26 (both inclusive) at screening.
  • able to provide written informed consent and having a responsible caregiver that can provide written assent prior to study participation. For patients who have been declared mentally incompetent, a legal representative will need to provide informed consent on their behalf.

Exclusion Criteria:

  • previously participated in an AD vaccine study and received active treatment
  • history or presence of an active autoimmune and/or cerebrovascular disease
  • history or presence of seizures, with an acute or chronic inflammation
  • clinically relevant atopic condition, who suffer from an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
  • immunosuppressive treatment including systemic steroids
  • obtained a vaccination (e.g. against influenza) within 4 weeks before the first study drug injection
  • advanced, severe, progressive or unstable disease that might interfere with the safety of the patient
  • started treatment with psychotropic medication within 3 months (4 weeks for SSRIs and other newer antidepressants without anticholinergic properties) prior to randomization with the exception of mild hypnotic drugs (e.g. zolpidem, zopiclone, oxazepam) and low doses of neuroleptic drugs (e.g. up to 2 mg risperidone).

Patients, who are on stable treatment with cholinesterase-inhibitors (ChEIs) and/or memantine for at least 3 months, and/or with SSRIs and/or other newer antidepressants (without anticholinergic properties) for at least 4 weeks before randomization, can be included into the study.

Contacts and Locations
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Information from the National Library of Medicine

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): NCT00411580


Locations
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Sweden
Novartis Investigative Site
Malmo, Sweden, 204 02
Novartis Investigative Site
Stockholm, Sweden, 141 86
Novartis Investigative Site
Stockholm, Sweden
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Principal Investigator: Novartis Investigator site
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00411580    
Other Study ID Numbers: CCAD106A2101
First Posted: December 14, 2006    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Mild, moderate Alzheimer's Disease (AD), Aß-specific antibody, CAD106
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