Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients

Tracking Information
First Submitted Date ICMJE	March 29, 2010
First Posted Date ICMJE	April 1, 2010
Last Update Posted Date	April 25, 2016
Study Start Date ICMJE	March 2010
Actual Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 30, 2010)	Safety and tolerability assessments (physical/neurological examinations, electrocardiogram (ECG), vital signs, standard and special laboratory evaluations, Magnetic Resonance Imaging (MRIs), Adverse events / Serious adverse events (AE/SAE) monitoring). [ Time Frame: Screening and through the end of the study to Week 90 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01097096 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 30, 2010)	Amyloid beta (Aβ)-specific and Qβ carrier-specific antibody response to CAD106 (with either adjuvant) in serum and cerebrospinal fluid (CSF) [ Time Frame: Screening and through the end of the study to Week 90 ]; Amyloid beta (Aβ)-specific and Qβ carrier-specific T-cell response to CAD106 (with either adjuvant) using peripheral blood mononuclear cells (PBMCs) [ Time Frame: Screening and at week 8 ]; Changes over time of the concentrations of disease related markers (Aβ1-40 and Aβ1-42 in plasma; Aβ1-40, Aβ1-42, total-tau, phospho-tau in CSF, or other markers) in patients with mild AD receiving CAD106 (with either adjuvant) compared to placebo [ Time Frame: Screening and through the end of the study to Week 90 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients
Official Title ICMJE	A 90-week, Multi-center, Randomized, Double-blind, Placebo-controlled Study in Patients With Mild Alzheimer's Disease (AD) to Investigate the Safety, Tolerability and Abeta-specific Antibody Response Following Repeated i.m. Injections of Adjuvanted CAD106
Brief Summary	This study will assess the safety, tolerability and Abeta-specific antibody response of repeated intra-muscular injections of adjuvanted CAD106 in patients with mild Alzheimer's Disease.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Alzheimer's Disease
Intervention ICMJE	Biological: CAD106
Study Arms	Active Comparator: CAD106 150μg + Adjuvant 1 at middle dose Intervention: Biological: CAD106; Active Comparator: CAD106 150μg + Adjuvant 1 at low dose Intervention: Biological: CAD106; Placebo Comparator: Placebo + Adjuvant 1 at middle dose Intervention: Biological: CAD106; Active Comparator: CAD106 150μg + Adjuvant 2 at middle dose Intervention: Biological: CAD106; Active Comparator: CAD106 150μg + Adjuvant 2 at low dose Intervention: Biological: CAD106; Placebo Comparator: Placebo + Adjuvant 2 at middle dose Intervention: Biological: CAD106; Active Comparator: CAD106 450μg + either Adjuvant 1 or 2 at middle dose Intervention: Biological: CAD106; Active Comparator: CAD106 450μg + either Adjuvant 1 or 2 at low dose Intervention: Biological: CAD106; Placebo Comparator: Placebo + either Adjuvant 1 or 2 at middle dose Intervention: Biological: CAD106
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 7, 2013)	177
Original Estimated Enrollment ICMJE; (submitted: March 30, 2010)	120
Actual Study Completion Date	December 2012
Actual Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Male and/or female patients below 85 years of age (inclusive); Diagnosis of mild Alzheimer's Disease; Mini-Mental State Examination (MMSE) 20 to 26 (inclusive) at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 4 weeks prior to clinical assessments Exclusion Criteria: Previously participated in an AD vaccine study and received active treatment; History or presence of an active autoimmune disease; History or presence of seizure disorder; Presence of significant coronary heart disease 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, tolerability and pharmacodynamic assessments of the patient Other protocol-defined inclusion/exclusion criteria may apply
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 85 Years (Child, Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, Canada, Germany, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United States
Removed Location Countries	Turkey
Administrative Information
NCT Number ICMJE	NCT01097096
Other Study ID Numbers ICMJE	CCAD106A2203; 2009-012394-35 ( EudraCT Number )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Novartis ( Novartis Pharmaceuticals )
Study Sponsor ICMJE	Novartis Pharmaceuticals
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account	Novartis
Verification Date	March 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP