Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795418
• Other study ID #: CCAD106A2202
• Status: Completed
• Phase: Phase 2
• Start date: October 2008

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male and/or female patients between 40 and 85 years of age (both inclusive)

• Diagnosis of mild Alzheimer's Disease (AD)

• 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 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 of the patient.

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• Placebo
Placebo comparator
• CAD106

Locations

Country	Name	City	State
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	ATP Clinical Research	Costa Mesa	California
United States	University of Texas Southwestern	Dallas	Texas
United States	Alexian Brothers Neuroscience Institute	Elk Grove Village	Illinois
United States	Sunrise Clinical Research	Hollywood	Florida
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	NOCCR Knoxville	Knoxville	Tennessee
United States	MidAmerica NeuroScience Research Foundation	Lenexa	Kansas
United States	Columbia University Medical Center	New York	New York
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI)		52 weeks
Secondary	Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.		52 weeks
Secondary	Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.		52 weeks
Secondary	Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.		52 weeks

External Links

•   Results for CCAD106A2202 from the Novartis Clinical Trials website