Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
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
1 other identifier
interventional
31
1 country
10
Brief Summary
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mid Alzheimer's disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 10, 2008
CompletedFirst Posted
Study publicly available on registry
November 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedDecember 17, 2020
May 1, 2012
2.1 years
November 10, 2008
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI)
52 weeks
Secondary Outcomes (3)
Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.
52 weeks
Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
52 weeks
Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
52 weeks
Study Arms (2)
CAD106
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male and/or female patients between 40 and 85 years of age (both inclusive)
- Diagnosis of mild Alzheimer's Disease (AD)
- 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.
You may not qualify if:
- 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 other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
- Advanced, severe, progressive or unstable disease that might interfere with the safety of the patient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (10)
ATP Clinical Research
Costa Mesa, California, 92626, United States
Alpine Clinical Research Center
Boulder, Colorado, 80304, United States
Sunrise Clinical Research
Hollywood, Florida, 33021, United States
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, 60007, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
MidAmerica NeuroScience Research Foundation
Lenexa, Kansas, 66214, United States
Columbia University Medical Center
New York, New York, 10032, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
NOCCR Knoxville
Knoxville, Tennessee, 37920, United States
University of Texas Southwestern
Dallas, Texas, 75390-9139, United States
Related Publications (1)
Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Abeta immunotherapy with CAD106 in mild Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 27;7(1):23. doi: 10.1186/s13195-015-0108-3. eCollection 2015.
PMID: 25918556DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2008
First Posted
November 21, 2008
Study Start
October 1, 2008
Primary Completion
November 1, 2010
Last Updated
December 17, 2020
Record last verified: 2012-05