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

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Biological: CAD106; Biological: Placebo

• Registration Number: NCT00795418
• Lead Sponsor: Novartis

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

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Primary Completion: 2010-11
• Status Verified: 2012-05
• Disposition First Submitted: 2012-05-02
• Disposition First Submitted QC: 2012-05-02
• Disposition First Posted: 2012-05-04
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAD106	CAD106	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.	52 weeks
Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.	52 weeks
Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.	52 weeks

Trial Locations

Locations (10)

NOCCR Knoxville; 🇺🇸 Knoxville, Tennessee, United States

ATP Clinical Research; 🇺🇸 Costa Mesa, California, United States

Alpine Clinical Research Center; 🇺🇸 Boulder, Colorado, United States

Sunrise Clinical Research; 🇺🇸 Hollywood, Florida, United States

Alexian Brothers Neuroscience Institute; 🇺🇸 Elk Grove Village, Illinois, United States

MidAmerica NeuroScience Research Foundation; 🇺🇸 Lenexa, Kansas, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Drexel University College of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States