Status:
COMPLETED
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
Lead Sponsor:
Novartis
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mid Alzheimer's disease
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00795418
Start Date
October 1 2008
Last Update
December 17 2020
Active Locations (10)
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1
ATP Clinical Research
Costa Mesa, California, United States, 92626
2
Alpine Clinical Research Center
Boulder, Colorado, United States, 80304
3
Sunrise Clinical Research
Hollywood, Florida, United States, 33021
4
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, United States, 60007