Long-Term Safety and Tolerability of AFFITOPE AD01

This study is currently recruiting participants.

Verified by Affiris GmbH, July 2008

First Received: July 4, 2008 Last Updated: July 7, 2008 History of Changes

Sponsored by:	Affiris GmbH
Information provided by:	Affiris GmbH
ClinicalTrials.gov Identifier:	NCT00711139

Purpose

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

Condition
Alzheimer's Disease

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Phase Ib Follow-up Study to Evaluate Long-Term Safety and Tolerability of Immunization With AFFITOPE AD01 Applied During AFFiRiS 001

Further study details as provided by Affiris GmbH:

Primary Outcome Measures:

Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunological and clinical efficacy (evaluated in an explorative manner only) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Serum

Estimated Enrollment:	24
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 AFFITOPE AD01
2 AFFITOPE AD01 + Adjuvant

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects having participated in AFFiRiS 001, as AFFiRiS 003 is a follow-up trial.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711139

Contacts

Contact: Martin Brunner, MD, Univ. Doz.

+43140400 ext 0

Locations

Austria
Department of Clinical Pharmacology, Medical University of Vienna	Recruiting
Vienna, Austria, 1090
Contact: Martin Brunner, MD, Univ. Doz.

Sponsors and Collaborators

Affiris GmbH

Investigators

Principal Investigator:

Markus Mueller, MD, Univ. Prof.

Medical University of Vienna

More Information

No publications provided

Responsible Party:	--- ( Affiris GmbH )
Study ID Numbers:	Affiris 003, EudraCT 2008-001455-22
Study First Received:	July 4, 2008
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00711139 History of Changes
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Affiris GmbH:

Alzheimer
Morbus Alzheimer
Alzheimer Vaccine

Vaccine
AD
A-beta immunotherapy

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009