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

Affiris

Status and phase: Terminated; Phase 2

Conditions: Alzheimer´s Disease

Treatments: Biological: AFFITOPE® AD02; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02008513

2012-005280-27 (EudraCT Number)

AFF006A

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

194 participants in 2 patient groups

Group 1

Active Comparator group

Description:

AFF006 Placebo groups receive 6 AFFITOPE® AD02 vaccinations

Treatment:

Biological: AFFITOPE® AD02

Group 2

Active Comparator group

Description:

AFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations

Treatment:

Biological: Placebo

Biological: AFFITOPE® AD02