Long-term Safety and Tolerability of AFFITOPE AD02

May 26, 2010 updated by: Affiris AG

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1010
        • Ordination Schmitz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects having participated in AFFiRiS 002

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
2
AFFITOPE AD02 with adjuvant
1
AFFITOPE AD02 without adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Long-term tolerability
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical and immunological efficacy (evaluated in an explorative manner only)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiris AG

Investigators

  • Principal Investigator: Margot Schmitz, MD Univ. D., Ordination Schmitz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

July 4, 2008

First Submitted That Met QC Criteria

July 7, 2008

First Posted (Estimate)

July 8, 2008

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Affiris 004
  • EudraCT 2008-002764-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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