- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00411580
Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Malmo, Sweden, 204 02
- Novartis Investigative Site
-
Stockholm, Sweden, 141 86
- Novartis Investigative Site
-
Stockholm, Sweden
- Novartis Investigative Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
|
Experimental: 1
CAD106
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.
|
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
|
at multiple timepoints including but not limited to baseline and through the end of the study to Week 52
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
at multiple timepoints including but not limited to baseline and through the end of the study to Week 52
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCAD106A2101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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