AD01 Follow up Extension Visit

January 25, 2011 updated by: Affiris AG

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

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

17

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

      • Wien, Austria, 1090
        • Univ. Klinik für Neurologie

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients having participated in AFFiRiS 001 and AFF003 and having received ≥1 vaccination with AFFITOPE AD01

Description

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

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

  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term tolerability and safety of AFFITOPE AD01
Time Frame: One year.
retrospective assessment of safety data
One year.

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Peter Dal-Bianco, MD, Univ. Klinik für Neurologie

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

September 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 21, 2010

Study Record Updates

Last Update Posted (Estimate)

January 26, 2011

Last Update Submitted That Met QC Criteria

January 25, 2011

Last Verified

January 1, 2011

More Information

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.

Clinical Trials on Alzheimer´s Disease

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