Mild 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 for solution for injection
Current Sponsor code: CAD106A
Other descriptive name: CAD106
Concentration unit: mg milligram(s)
Conce
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion criteria: • Male and/or female patients between 40 and 85 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) and satisfying the NINCDS-ADRA criteria for a clinical diagnosis of probable AD. • Mild AD as confirmed by MMSE score of 20 to 26 (both inclusive) at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks. • With sufficient education and able to provide written informed consent prior to study participation. Having support from a primary caregiver accepting to accompany the patient at visits and assess the patient’s condition. Please see enclosed protocol, section 5.1, for further 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: Key Exclusion criteria: • Any medical or neurological condition, other than AD, that contributes significantly to the patient’s dementia, including any CSF and/or cerebral MRI findings at screening. • History in the past two years or current diagnosis of CNS inflammation. • History or current diagnosis of significant cerebrovascular disease as defined by MRI central reader with a Hachinski score > 4. • >2 cerebral microhemorrhages or other relevant MRI findings. • History or current diagnosis of an active autoimmune disease. • Current diagnosis of a clinically relevant atopic condition. • Evidence of current inflammation or of any acute disease or infection in past 4 weeks, including fever (>38°C) in the 3 days prior to the first injection. • History of immunocompromise, or testing positive for Hepatitis B or Hepatitis C. • Vital signs outside of normal ranges for their age group • History of any severe or unstable cardiovascular disease, including QTc = 450msec in males and = 470msec in females. • Treatment with any of the following substances: - in the 3 months prior to first injection: • any investigational drug; any drug or treatment known to cause major organ system toxicity; - in the 6 weeks prior to first injection: • any new anticoagulants (excluding acetylsalicylic acid) or antiplatelet agents; • de novo initiation of treatment or change in dose of current treatment with cholinesterase-inhibitors (ChEIs) and/or memantine • start of treatment with psychotropic medication (with the exception of mild hypnotic drugs, and low doses of neuroleptic drugs); • centrally acting anticholinergic drugs including tricyclic and tetracyclic antidepressants or change in dose of non-anticholinergic antidepressant therapy; - in the 2 weeks before and after any of the three injections: • any other immunization • Participation in any other AD immunotherapy study receiving active treatment. • History in past 5 years or current treatment with immunosuppressive drugs, except local application of steroids. Please see enclosed protocol, section 5.1, for further details.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of repeated subcutaneous (s.c.) injections of 150µg CAD106 in patients with mild Alzheimer's Disease over the 52 weeks of the study.;Secondary Objective: • To determine the Aß-specific antibody response to CAD106 by means of evaluating titer levels (IgG and IgM) in serum and in CSF; and assessing Qß-specific antibody response: (IgG and IgM) in serum over the 52 weeks of the study. • To characterize Aß-specific and Qß-specific T-cell response in PBMCs from patients receiving CAD106 or placebo over the first 14 weeks of the study. ;Primary end point(s): The primary objective of this study is to establish the safety and tolerability of repeated injections of 150µg of CAD106. For the analysis of the primary objective, the following variables will be analysed: • Frequency of adverse events. • Frequency of cerebral MRI and CSF findings related to either inflammation, vasogenic edema or microhemorrhages. • Frequency of injection-related reactions from the patient’s diary. Please see enclosed protocol, section 10.4, for further details. | — |
Countries
France, Germany, Netherlands, Sweden, United Kingdom
Outcome results
None listed