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

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

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-10-31

Brief Summary

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

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AFFITOPE AD03 with adjuvant

No interventions assigned to this group

AFFITOPE AD03 without adjuvant

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Siegfried Kasper, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna ,Department for Psychiatry and Psychotherapy

Dieter Volc, Prim. Dr.

Role: PRINCIPAL_INVESTIGATOR

Studienzentrum der PROSENEX,AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt

Locations

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Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt

Vienna, , Austria

Site Status

Medical University of Vienna, Department for Psychiatry and Psychotherapy