Clinical trial NCT00795418: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Active immunization
Alzheimer's disease
Antibody
Vaccine
Central Nervous System Diseases
Neurodegenerative diseases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-11-21
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mid Alzheimer's disease


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

Primary outcomes:
measure: 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)
timeFrame: 52 weeks
Secondary outcomes:
measure: Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.
timeFrame: 52 weeks
measure: Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
timeFrame: 52 weeks
measure: Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: ATP Clinical Research
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Hollywood
country: United States
facility: Sunrise Clinical Research
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: Lenexa
country: United States
facility: MidAmerica NeuroScience Research Foundation
state: Kansas
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Knoxville
country: United States
facility: NOCCR Knoxville
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.