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

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Novartis

Status and phase

Completed
Phase 2

Conditions

Alzheimer's Disease

Treatments

Biological: MF59
Biological: CAD106
Biological: Placebo
Biological: Alum

Study type

Interventional

Funder types

Industry

Identifiers

NCT01097096
2009-012394-35 (EudraCT Number)
CCAD106A2203

Details and patient eligibility

About

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.

Enrollment

177 patients

Sex

All

Ages

Under 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

177 participants in 9 patient groups, including a placebo group

CAD106 150μg + Adjuvant 1 at middle dose
Active Comparator group
Treatment:
Biological: MF59
Biological: CAD106
CAD106 150μg + Adjuvant 1 at low dose
Active Comparator group
Treatment:
Biological: MF59
Biological: CAD106
Placebo + Adjuvant 1 at middle dose
Placebo Comparator group
Treatment:
Biological: Placebo
CAD106 150μg + Adjuvant 2 at middle dose
Active Comparator group
Treatment:
Biological: MF59
Biological: CAD106
CAD106 150μg + Adjuvant 2 at low dose
Active Comparator group
Treatment:
Biological: MF59
Biological: CAD106
Placebo + Adjuvant 2 at middle dose
Placebo Comparator group
Treatment:
Biological: Placebo
CAD106 450μg + either Adjuvant 1 or 2 at middle dose
Active Comparator group
Treatment:
Biological: Alum
Biological: MF59
Biological: CAD106
CAD106 450μg + either Adjuvant 1 or 2 at low dose
Active Comparator group
Treatment:
Biological: Alum
Biological: MF59
Biological: CAD106
Placebo + either Adjuvant 1 or 2 at middle dose
Placebo Comparator group
Treatment:
Biological: Placebo

Trial contacts and locations

31

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Data sourced from clinicaltrials.gov

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