ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD)

This study has been completed.

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00411580
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Biological: CAD106
Drug: Placebo
Phase I

Genetics Home Reference related topics:   Alzheimer disease   

MedlinePlus related topics:   Alzheimer's Disease    Coronary Artery Disease   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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. ]
  • 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:
  • 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 ]

Estimated Enrollment:   60
Study Start Date:   June 2005
Primary Completion Date:   March 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
CAD106
Biological: CAD106
2: Placebo Comparator
Placebo
Drug: Placebo

  Eligibility
Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411580

Locations
Sweden
Novartis Investigative Site    
      Stockholm, Sweden

Sponsors and Collaborators
Novartis

Investigators
Principal Investigator:     Novartis     Investigator site    
  More Information


Responsible Party:   Novartis ( External Affairs )
Study ID Numbers:   CCAD106A2101
First Received:   December 13, 2006
Last Updated:   July 24, 2008
ClinicalTrials.gov Identifier:   NCT00411580
Health Authority:   Sweden: Medical Products Agency

Keywords provided by Novartis:
Mild, moderate Alzheimer's Disease (AD), Aß-specific antibody, CAD106  

Study placed in the following topic categories:
Antibodies
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Coronary Artery Disease
Delirium

Additional relevant MeSH terms:
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 15, 2008




Links to all studies - primarily for crawlers