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

NCT ID: NCT01097096

Last Updated: 2021-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CAD106 150μg + Adjuvant 1 at middle dose

Group Type ACTIVE_COMPARATOR

CAD106

Intervention Type BIOLOGICAL

150μg and 450μg doses were reconstituted and administered via intramuscular injection

MF59

Intervention Type BIOLOGICAL

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

CAD106 150μg + Adjuvant 1 at low dose

Group Type ACTIVE_COMPARATOR

CAD106

Intervention Type BIOLOGICAL

150μg and 450μg doses were reconstituted and administered via intramuscular injection

MF59

Intervention Type BIOLOGICAL

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

Placebo + Adjuvant 1 at middle dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Identical placebo to CAD106 administered via intramuscular injection

CAD106 150μg + Adjuvant 2 at middle dose

Group Type ACTIVE_COMPARATOR

CAD106

Intervention Type BIOLOGICAL

150μg and 450μg doses were reconstituted and administered via intramuscular injection

MF59

Intervention Type BIOLOGICAL

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

CAD106 150μg + Adjuvant 2 at low dose

Group Type ACTIVE_COMPARATOR

CAD106

Intervention Type BIOLOGICAL

150μg and 450μg doses were reconstituted and administered via intramuscular injection

MF59

Intervention Type BIOLOGICAL

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

Placebo + Adjuvant 2 at middle dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Identical placebo to CAD106 administered via intramuscular injection

CAD106 450μg + either Adjuvant 1 or 2 at middle dose

Group Type ACTIVE_COMPARATOR

CAD106

Intervention Type BIOLOGICAL

150μg and 450μg doses were reconstituted and administered via intramuscular injection

Alum

Intervention Type BIOLOGICAL

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

MF59

Intervention Type BIOLOGICAL

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

CAD106 450μg + either Adjuvant 1 or 2 at low dose

Group Type ACTIVE_COMPARATOR

CAD106

Intervention Type BIOLOGICAL

150μg and 450μg doses were reconstituted and administered via intramuscular injection

Alum

Intervention Type BIOLOGICAL

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

MF59

Intervention Type BIOLOGICAL

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

Placebo + either Adjuvant 1 or 2 at middle dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Identical placebo to CAD106 administered via intramuscular injection

Interventions

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CAD106

150μg and 450μg doses were reconstituted and administered via intramuscular injection

Intervention Type BIOLOGICAL

Placebo

Identical placebo to CAD106 administered via intramuscular injection

Intervention Type BIOLOGICAL

Alum

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

Intervention Type BIOLOGICAL

MF59

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Costa Mesa, California, United States

Site Status

Novartis Investigative Site

Boulder, Colorado, United States

Site Status

Novartis Investigative Site

Hollywood, Florida, United States

Site Status

Novartis Investigative Site

Indianapolis, Indiana, United States

Site Status

Novartis Investigative Site

Eatontown, New Jersey, United States

Site Status

Novartis Investigative Site

Antwerp, , Belgium

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Greenfield Park, Quebec, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Magdeburg, , Germany

Site Status

Novartis Investigative Site

Nuremberg, , Germany

Site Status

Novartis Investigative Site

Brescia, BS, Italy

Site Status

Novartis Investigative Site

Florence, FI, Italy

Site Status

Novartis Investigative Site

Genova, GE, Italy

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Stavanger, , Norway

Site Status

Novartis Investigative Site

Sant Cugat del Vallès, Barcelona, Spain

Site Status

Novartis Investigative Site

Barakaldo, Basque Country, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Mölndal, , Sweden

Site Status

Novartis Investigative Site

Stockholm, , Sweden

Site Status

Novartis Investigative Site

Basel, , Switzerland

Site Status

Novartis Investigative Site

Biel, , Switzerland

Site Status

Novartis Investigative Site

Lausanne, , Switzerland

Site Status

Countries

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United States Belgium Canada Germany Italy Netherlands Norway Spain Sweden Switzerland

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=10603

Resuls for CCAD106A2203 on the Novartis Clinical Trial website

Other Identifiers

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2009-012394-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCAD106A2203

Identifier Type: -

Identifier Source: org_study_id

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