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

NCT01023685 | Completed Phase 2

• 1 other identifier: CCAD106A2202E1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 8

Brief Summary

This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.

Conditions

Alzheimer Disease

Keywords

Active immunization; Alzheimer disease; Antibody; Central Nervous System diseases; Neurodegenerative diseases; Vaccine

Outcome Measures

Primary Outcomes (1)

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

  66 weeks

Secondary Outcomes (3)

• Collect long-term safety information through SAE's collection for two years after completion of the extension study.

  2 years

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

  66 weeks

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

  66 weeks

Study Arms (1)

CAD106

EXPERIMENTAL

Biological: CAD106

Interventions

CAD106 BIOLOGICAL

CAD106

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have completed the core study with no significant safety concerns

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (8)

ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States

Location

Alpin Research Center

Boulder, Colorado, 80304, United States

Location

Sunrise Clinical Research, Inc.

Hollywood, Florida, 33021, United States

Location

Alexian Brothers Neuroscience Institute

Elk Grove Village, Illinois, 60007, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Volunteer Research Group

Knoxville, Tennessee, 37920, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Abeta immunotherapy with CAD106 in mild Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 27;7(1):23. doi: 10.1186/s13195-015-0108-3. eCollection 2015.

  PMID: 25918556 DERIVED

Related Links

• Results for CCAD106A2202E1 from the Novartis Clinical Trials website

MeSH Terms

Conditions

Alzheimer Disease; Central Nervous System Diseases; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: December 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 17, 2020

Record last verified: 2013-06

Locations

US (8)