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Clinical Trials/NCT00711321
NCT00711321
Completed
Not Applicable

Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD02 Applied During AFFiRiS 002

Affiris AG1 site in 1 country23 target enrollmentNovember 2008
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ConditionsAlzheimer's Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
Affiris AG
Enrollment
23
Locations
1
Primary Endpoint
Long-term tolerability
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the long-term tolerability and -safety of AFFITOPE AD02 applied during AFFiRiS 002

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
April 2010
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 patient and caregiver
  • •Patients having participated in AFF002 and having received at least 1 vaccination with AFFITOPE AD02
  • •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 AD02
  • •History of questionable compliance to visit schedule, patients not expected to finish the clinical trial

Outcomes

Primary Outcomes

Long-term tolerability

Time Frame: 1 year

Secondary Outcomes

  • Clinical and immunological efficacy (evaluated in an explorative manner only)(1 year)

Study Sites (1)

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