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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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

Key facts

Study ID

NCT00795418

Run by

Novartis

People needed

31

Starts

2008-10-01

Last updated by the study team

2020-12-17

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Indiana University School of Medicine — Indianapolis, Indiana, 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, United States
• NOCCR Knoxville — Knoxville, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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