Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AD03 Applied During AFF005A

Affiris

Status: Terminated

Conditions: Alzheimer's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01568086

AFF005B

Details and patient eligibility

About

This is a phase Ib follow-up study to evaluate long-term safety and tolerability of immunization with AFFITOPE AD03 applied during AFFiRiS 005A.

Enrollment: 16 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent signed and dated by the patient and the caregiver.
• Patients having participated in AFFiRiS 005A and received ≥1 vaccination with AFFITOPE AD03
• Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits and being available for the telephone phone calls

Exclusion criteria

• Patients having received no vaccination with AFFITOPE AD03
• History of questionable compliance to visit schedule; patients not expected to complete the clinical trial

Trial design

16 participants in 2 patient groups

AFFITOPE AD03 with adjuvant

AFFITOPE AD03 without adjuvant