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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

CAD106

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

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Centre Hospitalier Universitaire Pellegrin
Karolinska Universitetssjukhuset Huddinge
NeuroPsychologieZentrum
Moorgreen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00733863

First Posted

August 8, 2008

Last Updated

February 8, 2020

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00733863

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

Brief Summary

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

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

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Type

Biological

Intervention Name(s)

CAD106

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Universitaire Pellegrin

City

Bordeaux

Country

France

Facility Name

Karolinska Universitetssjukhuset Huddinge

City

Stockholm

Country

Sweden

Facility Name

NeuroPsychologieZentrum

City

Basel

Country

Switzerland

Facility Name

Moorgreen Hospital

City

Southampton

Country

United Kingdom

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

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

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