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

Alzheimer Disease Clinical Trial

Official title:

A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733863
• Other study ID #: CCAD106A2201
• Status: Completed
• Phase: Phase 2
• Start date: July 2008

Study information

• Verified date: May 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Biological:
• Placebo

• CAD106

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Pellegrin	Bordeaux
Sweden	Karolinska Universitetssjukhuset Huddinge	Stockholm
Switzerland	NeuroPsychologieZentrum	Basel
United Kingdom	Moorgreen Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

France,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.		52 weeks
Secondary	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.		52 weeks

External Links

•   Results for CCAD106A2201 on the Novartis clinical trials website