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OpenTrials
Completed

NCT Number: NCT01225809

AD01 Follow up Extension Visit

Patients who were vaccinated with AFFITOPE AD01 during AFFiRiS001 will undergo a long-term follow-up period to get more information regarding the safety profile of AFFITOPE AD01.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Univ. Klinik für Neurologie

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 AFF003 and having received ≥1 vaccination with AFFITOPE AD01
  • Availability of a partner/caregiver knowing the patient

Exclusion criteria

  • Patients having received no vaccination with AFFITOPE AD01
  • History of questionable compliance to visit schedule

Treatment and study plan

Primary outcomes

  1. Long term tolerability and safety of AFFITOPE AD01

    Time frame: One year.

    retrospective assessment of safety data

Sponsors and collaborators

Lead sponsor

Affiris AG

Industry

Registry information

Official study title

Observational Follow-up Extension Study-visit to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD01 Applied During AFFiRiS001 in Patients With Alzheimer's Disease

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Oct 21, 2010
Registry last updated
Jan 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.