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

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

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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