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Clinical Trials/NCT00711139
NCT00711139
Completed
Not Applicable

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

Affiris AG1 site in 1 country22 target enrollmentJune 2008
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ConditionsAlzheimer's Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
Affiris AG
Enrollment
22
Locations
1
Primary Endpoint
Tolerability
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
November 2009
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 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

Outcomes

Primary Outcomes

Tolerability

Time Frame: 1 year

Secondary Outcomes

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

Study Sites (1)

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