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

• ClinicalTrials.gov Identifier: NCT00733863
• Recruitment Status: Completed
• First Posted: August 13, 2008
• Last Update Posted: February 11, 2020
• Sponsor: Novartis
• Information provided by: Novartis

Study Description

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

• 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

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

Outcome Measures

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

• Ages Eligible for Study: 40 Years to 85 Years (Adult, Older Adult)
• 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

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

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
• Other Study ID Numbers: CCAD106A2201
• First Posted: August 13, 2008
• Last Update Posted: February 11, 2020
• 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