Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
CAD106
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Active immunization, Alzheimer disease, Antibody, Central Nervous System Diseases, Neurodegenerative diseases, Vaccine
Eligibility Criteria
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)
Sites / Locations
- Centre Hospitalier Universitaire Pellegrin
- Karolinska Universitetssjukhuset Huddinge
- NeuroPsychologieZentrum
- Moorgreen Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00733863
Brief Title
Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 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 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
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 mild Alzheimer's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Active immunization, Alzheimer disease, Antibody, Central Nervous System Diseases, Neurodegenerative diseases, Vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Type
Biological
Intervention Name(s)
CAD106
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
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:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Pellegrin
City
Bordeaux
Country
France
Facility Name
Karolinska Universitetssjukhuset Huddinge
City
Stockholm
Country
Sweden
Facility Name
NeuroPsychologieZentrum
City
Basel
Country
Switzerland
Facility Name
Moorgreen Hospital
City
Southampton
Country
United Kingdom
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
Learn more about this trial
Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.
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