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Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD)

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

CAD106

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Mild, moderate Alzheimer's Disease (AD), Aß-specific antibody, CAD106

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

males and/or females patients between 50 to 80 years of age (both inclusive).
female patients must be without childbearing potential (post-menopausal or surgically sterilized).
diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders, 4th edition).
mild to moderate AD as confirmed by Mini-Mental State Exam score of 16 to 26 (both inclusive) at screening.
able to provide written informed consent and having a responsible caregiver that can provide written assent prior to study participation. For patients who have been declared mentally incompetent, a legal representative will need to provide informed consent on their behalf.

Exclusion Criteria:

previously participated in an AD vaccine study and received active treatment
history or presence of an active autoimmune and/or cerebrovascular disease
history or presence of seizures, with an acute or chronic inflammation
clinically relevant atopic condition, who suffer from an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
immunosuppressive treatment including systemic steroids
obtained a vaccination (e.g. against influenza) within 4 weeks before the first study drug injection
advanced, severe, progressive or unstable disease that might interfere with the safety of the patient
started treatment with psychotropic medication within 3 months (4 weeks for SSRIs and other newer antidepressants without anticholinergic properties) prior to randomization with the exception of mild hypnotic drugs (e.g. zolpidem, zopiclone, oxazepam) and low doses of neuroleptic drugs (e.g. up to 2 mg risperidone).

Patients, who are on stable treatment with cholinesterase-inhibitors (ChEIs) and/or memantine for at least 3 months, and/or with SSRIs and/or other newer antidepressants (without anticholinergic properties) for at least 4 weeks before randomization, can be included into the study.

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

CAD106

Placebo

Outcomes

Primary Outcome Measures

Tolerability/safety assessments (physical/neurol.exam., ECG, vital signs, standard and special immunological laboratory evaluations, MRIs, EEGs, AE/SAE monitoring).

Antibody titers (IgM and IgM titers against amyloid and carrier protein).

Secondary Outcome Measures

Immune response, cognitive and functional assessments

Full Information

NCT ID

NCT00411580

First Posted

December 13, 2006

Last Updated

March 27, 2013

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00411580

Brief Title

Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD)

Official Title

A 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Time-lagged, Parallel Group Study in Patients With Mild to Moderate Alzheimer's Disease (AD) to Investigate the Safety, Tolerability and Aß-specific Antibody Response Following Three Subcutaneous Injections of CAD106

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

This study will evaluate the safety and tolerability and Aß-specific antibody response of CAD106 in patients with mild to moderate Alzheimer's Disease. Patients also had a 2 year follow-up to assess disease progression where no drug was administered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Mild, moderate Alzheimer's Disease (AD), Aß-specific antibody, CAD106

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

CAD106

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Biological

Intervention Name(s)

CAD106

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Tolerability/safety assessments (physical/neurol.exam., ECG, vital signs, standard and special immunological laboratory evaluations, MRIs, EEGs, AE/SAE monitoring).

Time Frame

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

Title

Antibody titers (IgM and IgM titers against amyloid and carrier protein).

Time Frame

at multiple timepoints including but not limited to baseline and through the end of the study to Week 52

Secondary Outcome Measure Information:

Title

Immune response, cognitive and functional assessments

Time Frame

at multiple timepoints including but not limited to baseline and through the end of the study to Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: males and/or females patients between 50 to 80 years of age (both inclusive). female patients must be without childbearing potential (post-menopausal or surgically sterilized). diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders, 4th edition). mild to moderate AD as confirmed by Mini-Mental State Exam score of 16 to 26 (both inclusive) at screening. able to provide written informed consent and having a responsible caregiver that can provide written assent prior to study participation. For patients who have been declared mentally incompetent, a legal representative will need to provide informed consent on their behalf. Exclusion Criteria: previously participated in an AD vaccine study and received active treatment history or presence of an active autoimmune and/or cerebrovascular disease history or presence of seizures, with an acute or chronic inflammation clinically relevant atopic condition, who suffer from an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression) immunosuppressive treatment including systemic steroids obtained a vaccination (e.g. against influenza) within 4 weeks before the first study drug injection advanced, severe, progressive or unstable disease that might interfere with the safety of the patient started treatment with psychotropic medication within 3 months (4 weeks for SSRIs and other newer antidepressants without anticholinergic properties) prior to randomization with the exception of mild hypnotic drugs (e.g. zolpidem, zopiclone, oxazepam) and low doses of neuroleptic drugs (e.g. up to 2 mg risperidone). Patients, who are on stable treatment with cholinesterase-inhibitors (ChEIs) and/or memantine for at least 3 months, and/or with SSRIs and/or other newer antidepressants (without anticholinergic properties) for at least 4 weeks before randomization, can be included into the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Novartis

Organizational Affiliation

Investigator site

Official's Role

Principal Investigator

Facility Information:

Facility Name

Novartis Investigative Site

City

Malmo

ZIP/Postal Code

204 02

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

22677258

Citation

Winblad B, Andreasen N, Minthon L, Floesser A, Imbert G, Dumortier T, Maguire RP, Blennow K, Lundmark J, Staufenbiel M, Orgogozo JM, Graf A. Safety, tolerability, and antibody response of active Abeta immunotherapy with CAD106 in patients with Alzheimer's disease: randomised, double-blind, placebo-controlled, first-in-human study. Lancet Neurol. 2012 Jul;11(7):597-604. doi: 10.1016/S1474-4422(12)70140-0. Epub 2012 Jun 6.

Results Reference

derived

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Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD)

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