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The study could not be performed as planned for organizational reasons.
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This is a phase Ib follow-up study to evaluate long-term safety and tolerability of immunization with AFFITOPE AD03 applied during AFFiRiS 005A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFFITOPE AD03 with adjuvant | |||
| AFFITOPE AD03 without adjuvant |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety/Tolerability |
| 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Efficacy | Changes from study AFF005A in:
|
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Inclusion Criteria:
Exclusion Criteria:
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Patients with mild to moderate Alzheimer's disease (MMSE 16 to 26)that have participated in AFF005A
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| Name | Affiliation | Role |
|---|---|---|
| Siegfried Kasper, Prof.Dr. | Medical University of Vienna ,Department for Psychiatry and Psychotherapy | Principal Investigator |
| Dieter Volc, Prim. Dr. | Studienzentrum der PROSENEX,AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt | Vienna | 1080 | Austria | |||
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Serum
| 52 weeks |
| Immunological | - Titre of antibodies specific for the immunizing peptide, N-terminal part of Aβ, Aβ itself, N-terminally truncated and Pyroglutamate-modified versions of Aβ, and KLH by ELlSA | 52 weeks |
| Medical University of Vienna, Department for Psychiatry and Psychotherapy |
| Vienna |
| 1090 |
| Austria |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |