Long-term Safety and Tolerability of AFFITOPE AD01

Affiris

Status: Completed

Conditions: Alzheimer's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT00711139

Affiris 003

EudraCT 2008-001455-22

Details and patient eligibility

About

The purpose of this study is to assess the long-term tolerability and -safety of AFFITOPE AD01 applied during AFFiRiS 001

Enrollment: 22 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent signed and dated by the patient or the patient's legal representative and the caregiver
• Patients having participated in AFFiRiS 001 and received at least 1 vaccination with AFFITOPE AD01
• Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits.

Exclusion criteria

• Patients having received no vaccination with AFFITOPE AD01
• Contraindication for MRI imaging
• History of questionable compliance to visit schedule, patients not expected to complete the clinical trial

Trial design

22 participants in 2 patient groups

1

Description:

AFFITOPE AD01

2

Description:

AFFITOPE AD01 + Adjuvant