Long-term Safety and Tolerability of AFFITOPE AD01

Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD01 Applied During AFFiRiS 001

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00711139

Enrollment

Registered

2008-07-08

Start date

2008-06-30

Completion date

2009-11-30

Last updated

2010-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer, Morbus Alzheimer, Alzheimer Vaccine, Vaccine, AD, A-beta immunotherapy

Brief summary

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

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Tolerability	1 year

Secondary

Measure	Time frame
Immunological and clinical efficacy (evaluated in an explorative manner only)	1 year

Countries

Austria

Outcome results