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

Alzheimer's Disease Clinical Trial

Official title:

A 90-week, Multi-center, Randomized, Double-blind, Placebo-controlled Study in Patients With Mild Alzheimer's Disease (AD) to Investigate the Safety, Tolerability and Abeta-specific Antibody Response Following Repeated i.m. Injections of Adjuvanted CAD106

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097096
• Other study ID #: CCAD106A2203
• Secondary ID: 2009-012394-35
• Status: Completed
• Phase: Phase 2
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• CAD106
150µg and 450µg doses were reconstituted and administered via intramuscular injection
• Placebo
Identical placebo to CAD106 administered via intramuscular injection
• Alum
An adjuvant (additive to increase potency ) of low, middle or high doses which was mixed with reconstituted active CAD106
• MF59
An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Antwerpen
Belgium	Novartis Investigative Site	Leuven
Canada	Novartis Investigative Site	Greenfield Park	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Nuernberg
Italy	Novartis Investigative Site	Brescia	BS
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Netherlands	Novartis Investigative Site	Amsterdam
Norway	Novartis Investigative Site	Stavanger
Spain	Novartis Investigative Site	Barakaldo	País Vasco
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Sant Cugat	Barcelona
Sweden	Novartis Investigative Site	Mölndal
Sweden	Novartis Investigative Site	Stockholm
Switzerland	Novartis Investigative Site	Basel
Switzerland	Novartis Investigative Site	Biel
Switzerland	Novartis Investigative Site	Lausanne
United States	Novartis Investigative Site	Boulder	Colorado
United States	Novartis Investigative Site	Costa Mesa	California
United States	Novartis Investigative Site	Eatontown	New Jersey
United States	Novartis Investigative Site	Hollywood	Florida
United States	Novartis Investigative Site	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Italy,  Netherlands,  Norway,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Amyloid beta (Aß)-specific and Qß 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
Secondary	Amyloid beta (Aß)-specific and Qß carrier-specific T-cell response to CAD106 (with either adjuvant) using peripheral blood mononuclear cells (PBMCs)		Screening and at week 8
Secondary	Changes over time of the concentrations of disease related markers (Aß1-40 and Aß1-42 in plasma; Aß1-40, Aß1-42, 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

External Links

•   Resuls for CCAD106A2203 on the Novartis Clinical Trial website