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AD01 Follow up Extension Visit

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ClinicalTrials.gov Identifier: NCT01225809
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : January 26, 2011
Sponsor:
Information provided by:
Affiris AG

Brief Summary:
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.

Condition or disease
Alzheimer´s Disease

Study Type : Observational
Actual Enrollment : 17 participants
Time Perspective: Retrospective
Official 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
Study Start Date : September 2010
Primary Completion Date : December 2010
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
AD01with or without adjuvant
Patients who have received at least one immunization of AD01 with or without adjuvant during AFF001



Primary Outcome Measures :
  1. Long term tolerability and safety of AFFITOPE AD01 [ Time Frame: One year. ]
    retrospective assessment of safety data



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients having participated in AFFiRiS 001 and AFF003 and having received ≥1 vaccination with AFFITOPE AD01
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225809


Locations
Austria
Univ. Klinik für Neurologie
Wien, Austria, 1090
Sponsors and Collaborators
Affiris AG
Investigators
Principal Investigator: Peter Dal-Bianco, MD Univ. Klinik für Neurologie

Responsible Party: Achim Schneeberger; CMO, AFFiRiS AG
ClinicalTrials.gov Identifier: NCT01225809     History of Changes
Other Study ID Numbers: AFF003E
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: January 2011

Keywords provided by Affiris AG:
AD01 follow-up extension

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders