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

Novartis

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Biological: Placebo; Biological: CAD106

Study type: Interventional

Funder types: Industry

Identifiers

NCT00795418

CCAD106A2202

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

CAD106

Experimental group

Treatment:

Biological: CAD106

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo