Follow-up Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in AFF006

This is an interventional treatment trial for Alzheimer´s Disease focused on measuring AFFITOPE® AD02, Alzheimer Disease, Dementia, Brain Disease, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Mental Disorders Read More

Inclusion Criteria:

• patients having participated in AFF006+having received 6 investigational medicinal product (IMP) injections+having completed all visits
• Written informed consent
• Availability of a partner/caregiver
• Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.
• Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial.

Exclusion Criteria:

• Pregnant women.
• Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects.
• Participation in the active treatment phase of another clinical trial except AFF006 within 3 months before Visit 0.
• History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
• Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.
• Contraindication for MRI imaging
• Presence and/or history of immunodeficiency (e.g., HIV infection).
• Prior and/or current treatment with experimental immunotherapeutics including Intravenous immunoglobulin (IVIG), AD antibody therapy and/or vaccines for AD except AD02.
• Prior and/or current treatment with immunosuppressive drugs.
• Treatment with benzodiazepines and/or nootropics administered at high doses and/or as newly started treatment.
• Treatment with anticholinergic drugs including Parkinson treatments, antidepressants (tricyclics), neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases.