Alzheimer's Disease. MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease
Conditions
Interventions
Product Name: CAD106
Product Code: CAD106A
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Not available yet
Current Sponsor code: CAD106A
Other descriptive nam
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in Group 1 of the Open-label extension have to fulfill all of the following criteria: 1. Patients who have completed the Core study with no significant safety concerns. 2. Cooperative, willing to complete all aspects of the Open-label extension and capable of doing so, either alone or with the aid of a responsible caregiver. 3. Residing with someone in the community throughout the Open-label extension or, if living alone, who have daily contact with a primary caregiver. 4. Primary caregiver willing to accept responsibility for assessing the condition of the patient throughout the Open-label extension, and for providing input to safety and tolerability assessments in accordance with all protocol requirements. 5. Able to provide written informed consent and having a responsible caregiver that can provide written assent prior to participation in the Open-label extension. Written informed consent must be obtained before any assessment is performed. All patients from the Core study not fulfilling Inclusion criteria above will be enrolled in Group 2 : patients of Group 2 will enter directly the 2-year SAE collection phase and no injection with CAD106 will be administered (please refer to the enclosed protocol for all the details). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who developed any of the following conditions during the Core study (including results obtained at Week 52) are not eligible for inclusion in Group 1 of the Open-label extension: 1. Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression). 2. Any medical or neurological condition, other than AD, that contributes significantly to the patient’s dementia (e.g., abnormal thyroid function tests, Vitamin B12 or folate deficiency, post-traumatic conditions, Huntington’s disease, Parkinson’s disease, Lyme’s disease, syphilis), including any CSF and/or cerebral MRI findings. 3. CNS inflammation as indicated by: • MRI findings indicative of either meningoencephalitis or of another adverse immune reaction (according to central reader evaluation); • OR signs of inflammation in CSF as defined by clinical judgment and according to ranges from the laboratory used. In most cases in a CSF sample not contaminated by blood, this will be shown by >5 leukocytes/ l, and protein above the age-defined normal range of the laboratory used (e.g. abnormal IgG index, IgG oligoclonal bands). 4. Clinical stroke, intracranial hemorrhage, aneurysms, more than one transitory ischemic attack or unexplained loss of consciousness, or current diagnosis of significant cerebrovascular disease as defined by MRI central reader. 5. Evidence of development of more than two additional cerebral microhemorrhages, defined as a focal T2* hypointensity less than 10 mm in diameter at screening MRI, as identified by MRI central reader. If a MR machine with field strength > 1.5 T is used, higher number of microhemorrhages will be acceptable as defined by the MRI central reader. 6. DSM-IV diagnosis of major depression and/or any other DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient’s response to study medication, including other primary neurodegenerative dementia, schizophrenia, or bipolar disorder. 7. Diagnosis of an active, uncontrolled seizure disorder. For a detailed description of the Exclusion Criteria, please refer to Section 4.2 of the enclosed protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the safety and tolerability of repeated injections of 150µg CAD106 in AD patients over the 66 weeks of the Extension study. • To evaluate the antibody response of repeated injections of CAD106 as measured y the titers levels of Aß-specific IgG in serum in AD patients over the 66 weeks of the Extension study. For a detailed description of the Study objectives, please refer to Section 2 of the enclosed protocol.;Secondary Objective: • To evaluate the antibody response of repeated injections of CAD106 as measured by the iters levels of Aß-specific IgM, Aß-specific IgG subtypes and Qß-specific IgG and IgM n serum over the 66 weeks of the Extension study. • To compare the antibody response (Aß-specific IgG in serum) between the 3 initial CAD106 injections given at 6-week intervals in the Core study and 4 initial CAD106 injections given at 12-week intervals in the Extension study in patients initially treated ith Placebo in the Core study. • To evaluate the antibody response (Aß-specific IgG in serum) after 4 additional injections n the Extension study in patients initially treated with CAD106 in the Core study. For a detailed description of the Study objectives, please refer to Section 2 of the enclosed protocol.;Primary end point(s): To evaluate the safety and tolerability of repeated injections of 150µg CAD106 in AD patients over the 66 weeks of the extension study. For further details, please see Section 2 of the enclosed protocol. | — |
Countries
France, Sweden, United Kingdom
Outcome results
None listed