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Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02

NCT ID: NCT01093664

Last Updated: 2010-10-19

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

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-07-31

Brief Summary

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This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who have received the vaccine within the clinical study AFF002.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AFFITOPE AD02

Group Type EXPERIMENTAL

AFFITOPE AD02

Intervention Type BIOLOGICAL

s.c. injection

Interventions

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AFFITOPE AD02

s.c. injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participation in AFF002 and AFF004

Exclusion Criteria

* Presence or history of allergy to components of the vaccine, if considered relevant by the investigator
* Contraindication for MRI imaging
* History and/or presence of autoimmune disease, if considered relevant by the investigator
* Active infectious disease (e.g., Hepatitis B, C)
* Presence and/or history of Immunodeficiency (e.g., HIV)
* Significant systemic illness
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiris AG

INDUSTRY

Sponsor Role lead

Responsible Party

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AFFiRiS AG

Principal Investigators

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Margot Schmitz, Univ. Doz.

Role: PRINCIPAL_INVESTIGATOR

Ordination Schmitz

Locations

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Ordination Schmitz

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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AFF004A

Identifier Type: -

Identifier Source: org_study_id