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OpenTrials
Completed

NCT Number: NCT00711139

Long-term Safety and Tolerability of AFFITOPE AD01

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

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 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

Treatment and study plan

Primary outcomes

  1. Tolerability

    Time frame: 1 year

Secondary outcomes

  1. Immunological and clinical efficacy (evaluated in an explorative manner only)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Affiris AG

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 8, 2008
Registry last updated
May 27, 2010

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.

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