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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: August 8, 2008
Last updated: May 10, 2010
Last verified: May 2010

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

Condition Intervention Phase
Alzheimer Disease
Biological: Placebo
Biological: CAD106
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: July 2008
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: CAD106
Placebo Comparator: 2 Biological: Placebo


Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its identifier: NCT00733863

Centre Hospitalier Universitaire Pellegrin
Bordeaux, France
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden
Basel, Switzerland
United Kingdom
Moorgreen Hospital
Southampton, United Kingdom
Sponsors and Collaborators
Principal Investigator: Novartis Pharmaceuticals Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Identifier: NCT00733863     History of Changes
Other Study ID Numbers: CCAD106A2201
Study First Received: August 8, 2008
Last Updated: May 10, 2010
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders processed this record on April 17, 2014