Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012394-35 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the safety, tolerability and Abeta-specific antibody response of repeated intra-muscular injections of adjuvanted CAD106 in patients with mild Alzheimer's Disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAD106 150μg + Adjuvant 1 at middle dose | Active Comparator |
| |
| CAD106 150μg + Adjuvant 1 at low dose | Active Comparator |
| |
| Placebo + Adjuvant 1 at middle dose | Placebo Comparator |
| |
| CAD106 150μg + Adjuvant 2 at middle dose | Active Comparator |
| |
| CAD106 150μg + Adjuvant 2 at low dose | Active Comparator |
| |
| Placebo + Adjuvant 2 at middle dose | Placebo Comparator |
| |
| CAD106 450μg + either Adjuvant 1 or 2 at middle dose | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAD106 | Biological | 150μg and 450μg doses were reconstituted and administered via intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessments (physical/neurological examinations, electrocardiogram (ECG), vital signs, standard and special laboratory evaluations, Magnetic Resonance Imaging (MRIs), Adverse events / Serious adverse events (AE/SAE) monitoring). | Screening and through the end of the study to Week 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Amyloid beta (Aβ)-specific and Qβ carrier-specific antibody response to CAD106 (with either adjuvant) in serum and cerebrospinal fluid (CSF) | Screening and through the end of the study to Week 90 | |
| Amyloid beta (Aβ)-specific and Qβ carrier-specific T-cell response to CAD106 (with either adjuvant) using peripheral blood mononuclear cells (PBMCs) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Costa Mesa | California | 92626 | United States | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| Resuls for CCAD106A2203 on the Novartis Clinical Trial website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| CAD106 450μg + either Adjuvant 1 or 2 at low dose | Active Comparator |
|
| Placebo + either Adjuvant 1 or 2 at middle dose | Placebo Comparator |
|
| Placebo | Biological | Identical placebo to CAD106 administered via intramuscular injection |
|
| Alum | Biological | An adjuvant (additive to increase potency ) of low, middle or high doses which was mixed with reconstituted active CAD106 |
|
| MF59 | Biological | An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106 |
|
| Screening and at week 8 |
| Changes over time of the concentrations of disease related markers (Aβ1-40 and Aβ1-42 in plasma; Aβ1-40, Aβ1-42, total-tau, phospho-tau in CSF, or other markers) in patients with mild AD receiving CAD106 (with either adjuvant) compared to placebo | Screening and through the end of the study to Week 90 |
| Boulder |
| Colorado |
| 80304 |
| United States |
| Novartis Investigative Site | Hollywood | Florida | 33021 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46202-5266 | United States |
| Novartis Investigative Site | Eatontown | New Jersey | 07724 | United States |
| Novartis Investigative Site | Antwerp | 2020 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Toronto | Ontario | M3B 2S7 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M6M 3Z5 | Canada |
| Novartis Investigative Site | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H1T 2M4 | Canada |
| Novartis Investigative Site | Magdeburg | 39120 | Germany |
| Novartis Investigative Site | Nuremberg | 90402 | Germany |
| Novartis Investigative Site | Brescia | BS | 25123 | Italy |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Genova | GE | 16132 | Italy |
| Novartis Investigative Site | Milan | MI | 20122 | Italy |
| Novartis Investigative Site | Roma | RM | 00161 | Italy |
| Novartis Investigative Site | Roma | RM | 00179 | Italy |
| Novartis Investigative Site | Amsterdam | 1081 GM | Netherlands |
| Novartis Investigative Site | Stavanger | 4068 | Norway |
| Novartis Investigative Site | Sant Cugat del Vallès | Barcelona | 08190 | Spain |
| Novartis Investigative Site | Barakaldo | Basque Country | 48903 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08003 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08041 | Spain |
| Novartis Investigative Site | Mölndal | 43141 | Sweden |
| Novartis Investigative Site | Stockholm | SE-141 86 | Sweden |
| Novartis Investigative Site | Basel | 4031 | Switzerland |
| Novartis Investigative Site | Biel | 2500 | Switzerland |
| Novartis Investigative Site | Lausanne | 1011 | Switzerland |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D002493 | Central Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C041524 | aluminum sulfate |
| C089950 | MF59 oil emulsion |
Not provided
Not provided
Not provided