Long-term Safety and Tolerability of AFFITOPE AD01

NCT ID: NCT00711139

Last Updated: 2010-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-11-30

Brief Summary

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

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

AFFITOPE AD01

No interventions assigned to this group

2

AFFITOPE AD01 + Adjuvant

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiris AG

INDUSTRY

Sponsor Role lead

Principal Investigators

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Markus Mueller, Univ. Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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EudraCT 2008-001455-22

Identifier Type: -

Identifier Source: secondary_id

Affiris 003

Identifier Type: -

Identifier Source: org_study_id

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