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

March 2, 2021 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
177

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2020
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3B 2S7
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M6M 3Z5
        • Novartis Investigative Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Novartis Investigative Site
  • Germany
      • Magdeburg, Germany, 39120
        • Novartis Investigative Site
      • Nuernberg, Germany, 90402
        • Novartis Investigative Site
  • Italy
    • BS
      • Brescia, BS, Italy, 25123
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Italy, 50134
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16132
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20122
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00161
        • Novartis Investigative Site
      • Roma, RM, Italy, 00179
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1081 GM
        • Novartis Investigative Site
  • Norway
      • Stavanger, Norway, 4068
        • Novartis Investigative Site
  • Spain
    • Barcelona
      • Sant Cugat, Barcelona, Spain, 08190
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08003
        • Novartis Investigative Site
      • Barcelona, Cataluña, Spain, 08041
        • Novartis Investigative Site
    • País Vasco
      • Barakaldo, País Vasco, Spain, 48903
        • Novartis Investigative Site
  • Sweden
      • Mölndal, Sweden, 43141
        • Novartis Investigative Site
      • Stockholm, Sweden, SE-141 86
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Novartis Investigative Site
      • Biel, Switzerland, 2500
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1011
        • Novartis Investigative Site
  • United States
    • California
      • Costa Mesa, California, United States, 92626
        • Novartis Investigative Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Novartis Investigative Site
    • Florida
      • Hollywood, Florida, United States, 33021
        • Novartis Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5266
        • Novartis Investigative Site
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: MF59
An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
Biological: Alum
An adjuvant (additive to increase potency ) of low, middle or 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: MF59
An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
Biological: Alum
An adjuvant (additive to increase potency ) of low, middle or 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Screening and through the end of the study to Week 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
Screening and through the end of the study to Week 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCAD106A2203
  • 2009-012394-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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