Extension of the AFFITOPE® AD02 AFFiRiS006 study to investigate the long-term safety and effectiveness of the AFFITOPE® AD02 vaccine

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 336

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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