Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.

Novartis27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Alzheimer Disease

Interventions

PlaceboBIOLOGICAL

CAD106BIOLOGICAL

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of Mild Alzheimer's Disease * 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 an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)

Locations (4)

Centre Hospitalier Universitaire Pellegrin

Bordeaux, France

Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden

NeuroPsychologieZentrum

Basel, Switzerland

Moorgreen Hospital

Southampton, United Kingdom

Outcomes

Primary Outcomes

Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.

Time frame: 52 weeks

Secondary Outcomes

Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through the end of the study to Week 52.

Time frame: 52 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.