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

Tracking Information

First Received Date ^ICMJE

November 10, 2008

Last Updated Date

December 16, 2010

Start Date ^ICMJE

October 2008

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00795418 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase II

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Biological: Placebo
Placebo comparator
Biological: CAD106

Study Arms

Experimental: CAD106
Intervention: Biological: CAD106
Placebo Comparator: Placebo
Intervention: Biological: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00795418

Other Study ID Numbers ^ICMJE

CCAD106A2202

Has Data Monitoring Committee

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP