Back to resultsSafety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
CAD106
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Active immunization, Alzheimer's disease, Antibody, Vaccine, Central Nervous System Diseases, Neurodegenerative diseases
Eligibility Criteria
Inclusion Criteria:
- 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.
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 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.
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- ATP Clinical Research
- Alpine Clinical Research Center
- Sunrise Clinical Research
- Alexian Brothers Neuroscience Institute
- Indiana University School of Medicine
- MidAmerica NeuroScience Research Foundation
- Columbia University Medical Center
- Drexel University College of Medicine
- NOCCR Knoxville
- University of Texas Southwestern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CAD106
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00795418
Brief Title
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mid Alzheimer's disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Active immunization, Alzheimer's disease, Antibody, Vaccine, Central Nervous System Diseases, Neurodegenerative diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAD106
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Intervention Type
Biological
Intervention Name(s)
CAD106
Primary Outcome Measure Information:
Title
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)
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Time Frame
52 weeks
Title
Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Time Frame
52 weeks
Title
Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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 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.
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
ATP Clinical Research
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Sunrise Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Alexian Brothers Neuroscience Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
MidAmerica NeuroScience Research Foundation
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
NOCCR Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9139
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25918556
Citation
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.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4704
Description
Results for CCAD106A2202 from the Novartis Clinical Trials website
Learn more about this trial
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
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