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Clinical Trials/NCT01225809
NCT01225809
Completed
Not Applicable

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

Affiris AG1 site in 1 country17 target enrollmentSeptember 2010
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ConditionsAlzheimer´s Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer´s Disease
Sponsor
Affiris AG
Enrollment
17
Locations
1
Primary Endpoint
Long term tolerability and safety of AFFITOPE AD01
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
January 2011
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Affiris AG

Eligibility 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

Outcomes

Primary Outcomes

Long term tolerability and safety of AFFITOPE AD01

Time Frame: One year.

retrospective assessment of safety data

Study Sites (1)

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