Alzheimer's Disease MedDRA version: 16.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852
Conditions
Interventions
Product Name: AFFITOPE® AD02
Product Code: AD02
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: AFFITOPE® AD02
Current Sponsor code: AFFITOPE® AD02
Other descriptive name: AD02
Conc
Sponsors
AFFiRiS AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients having participated in AFF006 as well as having received 6 IMP injections and having completed all visits, if not approved by the sponsor. 2. Written informed consent signed and dated by the patient and the caregiver. The patient’s capability to give informed consent has to be confirmed by an independent professional (psychiatrist, neurologist or psychologist dependent on the regulations in a given country). 3. Availability of a partner/caregiver knowing the patient and being able to accompany the patient at the visits and being available for the telephone interviews. 4. Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method. 5. Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial. 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 246
Exclusion criteria
Exclusion criteria: 1. Pregnant women. 2. Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects. 3. Participation in the active treatment phase of another clinical trial except AFF006 within 3 months before Visit 0. 4. History of questionable compliance to visit schedule; patients not expected to complete the clinical trial. 5. Presence or history of allergy to components of the vaccine, if considered relevant by the investigator. 6. Contraindication for Magnetic Resonance Imaging (MRI) imaging, including but not limited to pacemakers; cochlear implants, cerebral aneurysm clips; implanted infusion pumps; implanted nerve stimulators; metallic splinters in the eye; other magnetic, electronic, or mechanical implants; or any other clinical history or examination finding that, in the judgement of the investigator, would pose a potential hazard in combination with MRI. Exceptions may apply based on the number of Microhemorrhages (MHs) at baseline of AFF006 and their number over the follow-up MRIs. To be decided after consultaion with the sponsor. 7. Presence and/or history of Immunodeficiency (e.g., HIV infection). 8. Prior and/or current treatment with experimental immunotherapeutics including Intravenous Immunoglobulin (IVIG), Alzheimer’s Disease (AD) antibody therapy and/or vaccines for AD except AD02. 9. Prior and/or current treatment with immunosuppressive drugs. 10. Treatment with benzodiazepines and/or nootropics administered at high doses and/or as newly started treatment. 11. Treatment with anticholinergic drugs including Parkinson treatments, antidepressants (tricyclics), neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases. 12. Institutionalized patients. 13. Patients having shown a treatment-related SAE or a SUSAR in AFF006 are to be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - to assess the longterm safety and tolerability of continued AFFITOPE® AD02 administrations following a predefined vaccination schedule (boosts at regular intervals after priming) over a total period of 37 months (includes the 18 months of the preceding AFF006 study). - to assess the clinical activity (parameters for cognition and function) of vaccination with AFFITOPE® AD02 when extending the vaccination schedule applied within the preceding phase II study AFF006 by boosts at regular intervals (comparison to previous placebo patients now being vaccinated with verum).;Secondary Objective: To assess the immunological and clinical activity (parameters for cognition, function, global aspects, behavior, quality of life) of vaccination with AFFITOPE® AD02 when extending the vaccination schedule applied within the preceding phase II study AFF006 (comparison to previous placebo patients now being vaccinated with verum).;Primary end point(s): - Withdrawal criteria (number of patients who withdraw due to AEs, reason for withdrawal) - Adverse events (AEs) - Occurrence of any serious adverse events (SAE) possibly, probably or definitely related to the study vaccine at any time during the study. - Occurrence of local AEs (injection site pain, erythema (redness), hyperthermia at injection site, itching, edema (swelling), induration [hardening], granuloma within 1 week (Day 1-7) after each vaccination: Severity and duration - Occurrence of systemic AEs: headache, myalgia (muscle pain), fever, fatigue, nausea within 1 week (Day 1-7) after each vaccination: Severity and duration. - Physical and neurological examination results - Vital signs (blood pressure, heart rate, body weight) - Laboratory assessment (haematology, biochemistry, coagulation, and urinalysis) Magnetic Resonance Imaging (MRI) of the brain to assess for events associated with AD/Aß targeting drugs (e.g., vasogenic edema, microhemorrhages) Co-primary efficacy endpoints: - Alzheimer Disease Assessm | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 scale) Clinical Dementia Rating (CDR) [global aspects] Neuropsychiatric Inventory (NPI) [behavior] Quality of Life – in Patients with Alzheimer’s Disease (QOL-AD) Immunological parameters: Titres of IgG Abs specific for vaccine components (e.g. the immunizing peptide, monomeric Aß and KLH) as assessed by ELISA;Timepoint(s) of evaluation of this end point: at V0, V4, V5, V6, V7, EDV: 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) Clinical Dementia Rating (CDR) [global aspects] Neuropsychiatric Inventory (NPI) [behavior] at V7, EDV: Investigator’s global evaluation scale (IGE scale) at V0, V7, EDV: Quality of Life – in Patients with Alzheimer’s Disease (QOL-AD) at V1, V4b, V5b, V6b, V7, EDV: Immunological parameters | — |
Countries
Austria, Croatia, Czech Republic, France, Germany, Slovakia
Contacts
Public Contacta.o.Univ.Prof. Dr. Achim Schneeberg
AFFiRiS AG
Outcome results
None listed