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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00411580
First received: December 13, 2006
Last updated: March 27, 2013
Last verified: March 2013

December 13, 2006
March 27, 2013
June 2005
December 2008   (final data collection date for primary outcome measure)
  • 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. ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • -Safety/tolerability assessments: at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.
  • Antibody titer assessments: at multiple timepoints including but not limited to baseline and through the end of the study to Week 52
Complete list of historical versions of study NCT00411580 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
-Immune response, cognitive and functional assessments: at multiple timepoints including but not limited to screening and through the end of the study to Week 52
Not Provided
Not Provided
 
Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD)
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Biological: CAD106
  • Drug: Placebo
  • Experimental: 1
    CAD106
    Intervention: Biological: CAD106
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Winblad B, Andreasen N, Minthon L, Floesser A, Imbert G, Dumortier T, Maguire RP, Blennow K, Lundmark J, Staufenbiel M, Orgogozo JM, Graf A. Safety, tolerability, and antibody response of active Aβ immunotherapy with CAD106 in patients with Alzheimer's disease: randomised, double-blind, placebo-controlled, first-in-human study. Lancet Neurol. 2012 Jul;11(7):597-604. doi: 10.1016/S1474-4422(12)70140-0. Epub 2012 Jun 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
December 2008
December 2008   (final data collection date for primary outcome measure)

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.

Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00411580
CCAD106A2101
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Principal Investigator: Novartis Investigator site
Novartis
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP