Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AD03 Applied During AFF005A

November 5, 2013 updated by: Affiris AG

Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD03 Applied During AFFiRiS 005A

This is a phase Ib follow-up study to evaluate long-term safety and tolerability of immunization with AFFITOPE AD03 applied during AFFiRiS 005A.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

16

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, 1080
        • Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt
      • Wien, Austria, 1090
        • Medical University of Vienna, Department for Psychiatry and Psychotherapy

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with mild to moderate Alzheimer's disease (MMSE 16 to 26)that have participated in AFF005A

Description

Inclusion Criteria:

  • Written informed consent signed and dated by the patient and the caregiver.
  • Patients having participated in AFFiRiS 005A and received ≥1 vaccination with AFFITOPE AD03
  • Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits and being available for the telephone phone calls

Exclusion Criteria:

  • Patients having received no vaccination with AFFITOPE AD03
  • History of questionable compliance to visit schedule; patients not expected to complete 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
AFFITOPE AD03 with adjuvant
AFFITOPE AD03 without adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety/Tolerability
Time Frame: 52 weeks
  • Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal
  • Number and kind (description) of AEs
  • Number and kind (description) of SAEs
  • Changes from study AFF005A in: Physical and neurological examination/ Concomitant medication/ Vital signs (blood pressure, heart rate, respiratory rate, body temperature)/ Body mass (weight)/ MRI of the brain/ ECG/ Laboratory assessment (haematology, biochemistry, coagulation, serology, APP crossreactivity and urinalysis)
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Efficacy
Time Frame: 52 weeks

Changes from study AFF005A in:

  • CIBIC plus (Clinician's Interview-Based Impression of Change, + carer interview)
  • ADAScog (Alzheimer Disease Assessment Scale-cognitive)
  • CERAD plus (The Consortium to Establish a Registry for AD)
  • Neuropsychiatric inventory
  • Activity of daily living
  • Quality of life in patients with Alzheimer's disease
  • Investigator's global evaluation scale
  • MRI brain volumetry
52 weeks
Immunological
Time Frame: 52 weeks
- Titre of antibodies specific for the immunizing peptide, N-terminal part of Aβ, Aβ itself, N-terminally truncated and Pyroglutamate-modified versions of Aβ, and KLH by ELlSA
52 weeks

Collaborators and Investigators

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

Sponsor

Affiris AG

Investigators

  • Principal Investigator: Siegfried Kasper, Prof.Dr., Medical University of Vienna ,Department for Psychiatry and Psychotherapy
  • Principal Investigator: Dieter Volc, Prim. Dr., Studienzentrum der PROSENEX,AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt

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

December 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

December 16, 2011

First Submitted That Met QC Criteria

March 29, 2012

First Posted (Estimate)

April 2, 2012

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFF005B

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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