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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CAD106
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Active immunization, Alzheimer disease, Antibody, Central Nervous System diseases, Neurodegenerative diseases, Vaccine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • ATP Clinical Research, Inc.
  • Alpin Research Center
  • Sunrise Clinical Research, Inc.
  • Alexian Brothers Neuroscience Institute
  • Indiana University School of Medicine
  • Drexel University College of Medicine
  • Volunteer Research Group
  • University of Texas Southwestern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAD106

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Collect long-term safety information through SAE's collection for two years after completion of the extension study.
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.
Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study.

Full Information

First Posted
December 1, 2009
Last Updated
December 11, 2020
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01023685
Brief Title
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
Official Title
An Open-label Extension to a 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in Patients With Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Active immunization, Alzheimer disease, Antibody, Central Nervous System diseases, Neurodegenerative diseases, Vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAD106
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CAD106
Primary Outcome Measure Information:
Title
Safety/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66.
Time Frame
66 weeks
Secondary Outcome Measure Information:
Title
Collect long-term safety information through SAE's collection for two years after completion of the extension study.
Time Frame
2 years
Title
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.
Time Frame
66 weeks
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Alpin Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Sunrise Clinical Research, Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Alexian Brothers Neuroscience Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25918556
Citation
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.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=8123
Description
Results for CCAD106A2202E1 from the Novartis Clinical Trials website

Learn more about this trial

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

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