We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01097096
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Biological: CAD106 Biological: Placebo Biological: Alum Biological: MF59 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: CAD106 150μg + Adjuvant 1 at middle dose Biological: CAD106
150μg and 450μg doses were reconstituted and administered via intramuscular injection

Biological: MF59
An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
Active Comparator: CAD106 150μg + Adjuvant 1 at low dose Biological: CAD106
150μg and 450μg doses were reconstituted and administered via intramuscular injection

Biological: MF59
An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
Placebo Comparator: Placebo + Adjuvant 1 at middle dose Biological: Placebo
Identical placebo to CAD106 administered via intramuscular injection
Active Comparator: CAD106 150μg + Adjuvant 2 at middle dose Biological: CAD106
150μg and 450μg doses were reconstituted and administered via intramuscular injection

Biological: MF59
An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
Active Comparator: CAD106 150μg + Adjuvant 2 at low dose Biological: CAD106
150μg and 450μg doses were reconstituted and administered via intramuscular injection

Biological: MF59
An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
Placebo Comparator: Placebo + Adjuvant 2 at middle dose Biological: Placebo
Identical placebo to CAD106 administered via intramuscular injection
Active Comparator: CAD106 450μg + either Adjuvant 1 or 2 at middle dose Biological: CAD106
150μg and 450μg doses were reconstituted and administered via intramuscular injection

Biological: Alum
An adjuvant (additive to increase potency ) of low, middle or high doses which was mixed with reconstituted active CAD106

Biological: MF59
An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
Active Comparator: CAD106 450μg + either Adjuvant 1 or 2 at low dose Biological: CAD106
150μg and 450μg doses were reconstituted and administered via intramuscular injection

Biological: Alum
An adjuvant (additive to increase potency ) of low, middle or high doses which was mixed with reconstituted active CAD106

Biological: MF59
An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
Placebo Comparator: Placebo + either Adjuvant 1 or 2 at middle dose Biological: Placebo
Identical placebo to CAD106 administered via intramuscular injection


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097096


Locations
Layout table for location information
United States, California
Novartis Investigative Site
Costa Mesa, California, United States, 92626
United States, Colorado
Novartis Investigative Site
Boulder, Colorado, United States, 80304
United States, Florida
Novartis Investigative Site
Hollywood, Florida, United States, 33021
United States, Indiana
Novartis Investigative Site
Indianapolis, Indiana, United States, 46202-5266
United States, New Jersey
Novartis Investigative Site
Eatontown, New Jersey, United States, 07724
Belgium
Novartis Investigative Site
Antwerpen, Belgium, 2020
Novartis Investigative Site
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M3B 2S7
Novartis Investigative Site
Toronto, Ontario, Canada, M6M 3Z5
Canada, Quebec
Novartis Investigative Site
Greenfield Park, Quebec, Canada, J4V 2J2
Novartis Investigative Site
Montreal, Quebec, Canada, H1T 2M4
Germany
Novartis Investigative Site
Magdeburg, Germany, 39120
Novartis Investigative Site
Nuernberg, Germany, 90402
Italy
Novartis Investigative Site
Brescia, BS, Italy, 25123
Novartis Investigative Site
Firenze, FI, Italy, 50134
Novartis Investigative Site
Genova, GE, Italy, 16132
Novartis Investigative Site
Milano, MI, Italy, 20122
Novartis Investigative Site
Roma, RM, Italy, 00161
Novartis Investigative Site
Roma, RM, Italy, 00179
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands, 1081 GM
Norway
Novartis Investigative Site
Stavanger, Norway, 4068
Spain
Novartis Investigative Site
Sant Cugat, Barcelona, Spain, 08190
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08003
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08041
Novartis Investigative Site
Barakaldo, País Vasco, Spain, 48903
Sweden
Novartis Investigative Site
Mölndal, Sweden, 43141
Novartis Investigative Site
Stockholm, Sweden, SE-141 86
Switzerland
Novartis Investigative Site
Basel, Switzerland, 4031
Novartis Investigative Site
Biel, Switzerland, 2500
Novartis Investigative Site
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01097096    
Other Study ID Numbers: CCAD106A2203
2009-012394-35 ( EudraCT Number )
First Posted: April 1, 2010    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Active immunization
Alzheimer disease
Antibody
 Central Nervous System Diseases
Neurodegenerative diseases
Vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders