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

Study Overview
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Brief Summary
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This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.

Official Title
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A Randomized, Controlled, Parallel Group, Double-blind, Multi-centre, Phase IIb Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in the AFFITOPE® AD02 Phase II Study AFF006.

Conditions
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Alzheimer´s Disease

Intervention / Treatment
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* Biological: AFFITOPE® AD02
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>AFF006 Placebo groups receive 6 AFFITOPE® AD02 vaccinations | Biological: AFFITOPE® AD02<br> <br> |
| Active Comparator: Group 2<br>AFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations | Biological: AFFITOPE® AD02<br> <br> Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Measures of Primary Safety and Tolerability Endpoints | Withdrawal criteria Number of Adverse events (AEs) Number of any serious adverse events (SAE) Alzheimer's Disease Assessment Scale - Cognition (ADAScog) Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL) | 19 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Measures of Secondary Efficacy Endpoints | Clinical Dementia Rating Sum of Boxes (CDR-sb) Free and Cued Selective Reminding Test (FCSRT) Standard neuropsychological test battery (CogState) Mini-Mental State Examination (MMSE) Investigator's global evaluation scale (IGE) CDR [global aspects] Neuropsychiatric Inventory (NPI) [behavior] quality of life (QOL) -AD | 19 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AFFITOPE® AD02, Alzheimer Disease, Dementia, Brain Disease, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Mental Disorders