Clinical trial NCT01023685: To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
Official title: An Open-label Extension to a 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in Patients With Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Active immunization
Alzheimer disease
Antibody
Central Nervous System diseases
Neurodegenerative diseases
Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.


Eligibility criteria: Inclusion Criteria:

* Patients who have completed the core study with no significant safety concerns

Exclusion Criteria:

* Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression).
* Diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease.
* Diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Safety/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66.
timeFrame: 66 weeks
Secondary outcomes:
measure: Collect long-term safety information through SAE's collection for two years after completion of the extension study.
timeFrame: 2 years
measure: Immune response, cognitive and functional assessments at multiple time points including but not limited to baseline, and through to the end of the study to week 66.
timeFrame: 66 weeks
measure: Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study.
timeFrame: 66 weeks
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Boulder
country: United States
facility: Alpin Research Center
state: Colorado
city: Hollywood
country: United States
facility: Sunrise Clinical Research, Inc.
state: Florida
city: Elk Grove Village
country: United States
facility: Alexian Brothers Neuroscience Institute
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
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.