Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

This study will assess the safety, tolerability and Abeta-specific antibody response of repeated intra-muscular injections of adjuvanted CAD106 in patients with mild Alzheimer's Disease.

Key facts

Study ID

NCT01097096

Run by

Novartis Pharmaceuticals

People needed

177

Starts

2010-03-01

Expected to finish

2012-12-01

Last updated by the study team

2021-03-05

Who can join

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

You may qualify if…

• Male and/or female patients below 85 years of age (inclusive)
• Diagnosis of mild Alzheimer's Disease
• Mini-Mental State Examination (MMSE) 20 to 26 (inclusive) at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 4 weeks prior to clinical assessments

You may not qualify if…

• Previously participated in an AD vaccine study and received active treatment
• History or presence of an active autoimmune disease
• History or presence of seizure disorder
• Presence of significant coronary heart disease 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, tolerability and pharmacodynamic assessments of the patient
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Costa Mesa, California, United States
• Novartis Investigative Site — Boulder, Colorado, United States
• Novartis Investigative Site — Hollywood, Florida, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Eatontown, New Jersey, United States
• Novartis Investigative Site — Antwerp, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Greenfield Park, Quebec, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Magdeburg, Germany
• Novartis Investigative Site — Nuremberg, Germany
• Novartis Investigative Site — Brescia, BS, Italy
• Novartis Investigative Site — Florence, FI, Italy
• Novartis Investigative Site — Genova, GE, Italy
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Amsterdam, Netherlands
• Novartis Investigative Site — Stavanger, Norway
• Novartis Investigative Site — Sant Cugat del Vallès, Barcelona, Spain
• Novartis Investigative Site — Barakaldo, Basque Country, Spain
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Barcelona, Catalonia, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.