Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.

Study Description

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Brief Summary:

This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mild Alzheimer's disease.

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease	Biological: Placebo; Biological: CAD106	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	27 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106
Study Start Date :	July 2008
Actual Primary Completion Date :	February 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1	Biological: CAD106
Placebo Comparator: 2	Biological: Placebo

Outcome Measures

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Primary Outcome Measures :

1. Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52. [ Time Frame: 52 weeks ]

Secondary Outcome Measures :

1. Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through the end of the study to Week 52. [ Time Frame: 52 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Diagnosis of Mild Alzheimer's Disease
• Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks

Exclusion Criteria:

• Previously participated in an AD vaccine study and received active treatment
• History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
• History or presence of seizures and/or cerebrovascular disease.
• Presence of an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)

Contacts and Locations

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Locations

France
Centre Hospitalier Universitaire Pellegrin
Bordeaux, France
Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden
Switzerland
NeuroPsychologieZentrum
Basel, Switzerland
United Kingdom
Moorgreen Hospital
Southampton, United Kingdom

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:	Novartis Pharmaceuticals	Novartis

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Aβ immunotherapy with CAD106 in mild Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 27;7(1):23. doi: 10.1186/s13195-015-0108-3. eCollection 2015.

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00733863 History of Changes
Other Study ID Numbers:	CCAD106A2201
First Posted:	August 13, 2008
Last Update Posted:	May 12, 2010
Last Verified:	May 2010

Keywords provided by Novartis:

Active immunization; Alzheimer disease; Antibody	Central Nervous System Diseases; Neurodegenerative diseases; Vaccine

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders