To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients

Novartis21 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer Disease

Interventions

CAD106BIOLOGICAL

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who have completed the Core study with no significant safety concerns Exclusion Criteria: * Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression). * Diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease. * diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation.

Locations (4)

Novartis Investigative Site

Bordeaux, France

Novartis Investigative Site

Stockholm, Sweden

Novartis Investigative Site

Basel, Switzerland

Novartis Investigative Site

Southampton, United Kingdom

Outcomes

Primary Outcomes

Safety/tolerability assessments at multiple timepoints including but not limited to screening, and through to the end of the study to week 66.

Time frame: 66 weeks

Secondary Outcomes

Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through to the end of the study to week 66.

Time frame: 66 weeks

Evaluate the antibody response after 4 additional injections in the Extension study in patients initially treated with CAD106 in the Core study.

Time frame: 66 weeks

Collect long-term safety information through SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1.

Time frame: 2 years

Data from ClinicalTrials.gov

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