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

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Biological: CAD106; Biological: Placebo; Biological: Alum; Biological: MF59

• Registration Number: NCT01097096
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-04-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Disposition First Submitted: 2016-03-22
• Disposition First Submitted QC: 2016-03-22
• Disposition First Posted: 2016-04-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAD106 150μg + Adjuvant 2 at low dose	CAD106	-
CAD106 450μg + either Adjuvant 1 or 2 at low dose	Alum	-
CAD106 150μg + Adjuvant 1 at low dose	CAD106	-
CAD106 150μg + Adjuvant 1 at middle dose	CAD106	-
CAD106 150μg + Adjuvant 2 at middle dose	MF59	-
CAD106 450μg + either Adjuvant 1 or 2 at low dose	MF59	-
Placebo + Adjuvant 1 at middle dose	Placebo	-
CAD106 450μg + either Adjuvant 1 or 2 at low dose	CAD106	-
CAD106 450μg + either Adjuvant 1 or 2 at middle dose	CAD106	-
CAD106 150μg + Adjuvant 2 at middle dose	CAD106	-
CAD106 150μg + Adjuvant 2 at low dose	MF59	-
Placebo + Adjuvant 2 at middle dose	Placebo	-
CAD106 450μg + either Adjuvant 1 or 2 at middle dose	Alum	-
CAD106 150μg + Adjuvant 1 at middle dose	MF59	-
CAD106 150μg + Adjuvant 1 at low dose	MF59	-
CAD106 450μg + either Adjuvant 1 or 2 at middle dose	MF59	-
Placebo + either Adjuvant 1 or 2 at middle dose	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇭 Lausanne, Switzerland