Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 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
27
4 countries
4
Brief Summary
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mild Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 alzheimer-disease
4 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
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 8, 2008
CompletedFirst Posted
Study publicly available on registry
August 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedFebruary 11, 2020
May 1, 2010
1.6 years
August 8, 2008
February 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.
52 weeks
Secondary Outcomes (1)
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.
52 weeks
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
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 an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (4)
Centre Hospitalier Universitaire Pellegrin
Bordeaux, France
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden
NeuroPsychologieZentrum
Basel, Switzerland
Moorgreen Hospital
Southampton, United Kingdom
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis Pharmaceuticals
Novartis
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
Study Record Dates
First Submitted
August 8, 2008
First Posted
August 13, 2008
Study Start
July 1, 2008
Primary Completion
February 1, 2010
Last Updated
February 11, 2020
Record last verified: 2010-05