NCT01097096

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Typical duration for phase_2

Geographic Reach
10 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

March 29, 2010

Last Update Submit

March 2, 2021

Conditions

Alzheimer's Disease

Keywords

Active immunizationAlzheimer diseaseAntibodyCentral Nervous System DiseasesNeurodegenerative diseasesVaccine

Outcome Measures

Primary Outcomes (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).

    Screening and through the end of the study to Week 90

Secondary Outcomes (3)

  • Amyloid beta (Aβ)-specific and Qβ carrier-specific antibody response to CAD106 (with either adjuvant) in serum and cerebrospinal fluid (CSF)

    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)

    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

    Screening and through the end of the study to Week 90

Study Arms (9)

CAD106 150μg + Adjuvant 1 at middle dose

ACTIVE COMPARATOR
Biological: CAD106Biological: MF59

CAD106 150μg + Adjuvant 1 at low dose

ACTIVE COMPARATOR
Biological: CAD106Biological: MF59

Placebo + Adjuvant 1 at middle dose

PLACEBO COMPARATOR
Biological: Placebo

CAD106 150μg + Adjuvant 2 at middle dose

ACTIVE COMPARATOR
Biological: CAD106Biological: MF59

CAD106 150μg + Adjuvant 2 at low dose

ACTIVE COMPARATOR
Biological: CAD106Biological: MF59

Placebo + Adjuvant 2 at middle dose

PLACEBO COMPARATOR
Biological: Placebo

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

ACTIVE COMPARATOR
Biological: CAD106Biological: AlumBiological: MF59

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

ACTIVE COMPARATOR
Biological: CAD106Biological: AlumBiological: MF59

Placebo + either Adjuvant 1 or 2 at middle dose

PLACEBO COMPARATOR
Biological: Placebo

Interventions

CAD106BIOLOGICAL

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

CAD106 150μg + Adjuvant 1 at low doseCAD106 150μg + Adjuvant 1 at middle doseCAD106 150μg + Adjuvant 2 at low doseCAD106 150μg + Adjuvant 2 at middle doseCAD106 450μg + either Adjuvant 1 or 2 at low doseCAD106 450μg + either Adjuvant 1 or 2 at middle dose
PlaceboBIOLOGICAL

Identical placebo to CAD106 administered via intramuscular injection

Placebo + Adjuvant 1 at middle dosePlacebo + Adjuvant 2 at middle dosePlacebo + either Adjuvant 1 or 2 at middle dose
AlumBIOLOGICAL

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

CAD106 450μg + either Adjuvant 1 or 2 at low doseCAD106 450μg + either Adjuvant 1 or 2 at middle dose
MF59BIOLOGICAL

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 doseCAD106 150μg + Adjuvant 1 at middle doseCAD106 150μg + Adjuvant 2 at low doseCAD106 150μg + Adjuvant 2 at middle doseCAD106 450μg + either Adjuvant 1 or 2 at low doseCAD106 450μg + either Adjuvant 1 or 2 at middle dose

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Novartis Investigative Site

Costa Mesa, California, 92626, United States

Location

Novartis Investigative Site

Boulder, Colorado, 80304, United States

Location

Novartis Investigative Site

Hollywood, Florida, 33021, United States

Location

Novartis Investigative Site

Indianapolis, Indiana, 46202-5266, United States

Location

Novartis Investigative Site

Eatontown, New Jersey, 07724, United States

Location

Novartis Investigative Site

Antwerp, 2020, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Toronto, Ontario, M3B 2S7, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M6M 3Z5, Canada

Location

Novartis Investigative Site

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H1T 2M4, Canada

Location

Novartis Investigative Site

Magdeburg, 39120, Germany

Location

Novartis Investigative Site

Nuremberg, 90402, Germany

Location

Novartis Investigative Site

Brescia, BS, 25123, Italy

Location

Novartis Investigative Site

Florence, FI, 50134, Italy

Location

Novartis Investigative Site

Genova, GE, 16132, Italy

Location

Novartis Investigative Site

Milan, MI, 20122, Italy

Location

Novartis Investigative Site

Roma, RM, 00161, Italy

Location

Novartis Investigative Site

Roma, RM, 00179, Italy

Location

Novartis Investigative Site

Amsterdam, 1081 GM, Netherlands

Location

Novartis Investigative Site

Stavanger, 4068, Norway

Location

Novartis Investigative Site

Sant Cugat del Vallès, Barcelona, 08190, Spain

Location

Novartis Investigative Site

Barakaldo, Basque Country, 48903, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08041, Spain

Location

Novartis Investigative Site

Mölndal, 43141, Sweden

Location

Novartis Investigative Site

Stockholm, SE-141 86, Sweden

Location

Novartis Investigative Site

Basel, 4031, Switzerland

Location

Novartis Investigative Site

Biel, 2500, Switzerland

Location

Novartis Investigative Site

Lausanne, 1011, Switzerland

Location

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseCentral Nervous System DiseasesNeurodegenerative Diseases

Interventions

aluminum sulfateMF59 oil emulsion

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesNervous System DiseasesTauopathiesNeurocognitive DisordersMental Disorders

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2010

First Posted

April 1, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

NO(1)DE(2)SE(2)US(5)CH(3)IT(6)NL(1)CA(4)ES(5)BE(2)