NCT01357629

Brief Summary

This study examines the long term Safety Follow-up of first patients vaccinated with AD02.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

1.8 years

First QC Date

March 21, 2011

Last Update Submit

December 10, 2013

Conditions

Alzheimer´s Disease

Keywords

Vaccination follow-up

Outcome Measures

Primary Outcomes (1)

  • Safety

    collection and evaluation of AEs, SAEs

    up to 2 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Alzheimer´s Disease

You may qualify if:

  • participation in AFF002 and AFF004A

You may not qualify if:

  • no vaccination with AD02

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Studienzentrum der PROSENEX Ambulatoriumsbetriebs GmbH

Vienna, Vienna, 1080, Austria

Location

Univ. Klinik für Psychiatire und Psychotherapie

Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Officials

  • Achim Schneeberger, MD

    Sponsor GmbH

    STUDY DIRECTOR

  • Siegfried Kasper, MD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2011

First Posted

May 23, 2011

Study Start

July 1, 2011

Primary Completion

April 1, 2013

Study Completion

November 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

AU(2)