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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • 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

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
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: 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

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

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

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

March 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

March 30, 2010

First Posted (Estimate)

April 1, 2010

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Alzheimer's Disease

Clinical Trials on CAD106

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe