NCT01225809

Brief Summary

Patients who were vaccinated with AFFITOPE AD01 during AFFiRiS001 will undergo a long-term follow-up period to get more information regarding the safety profile of AFFITOPE AD01.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 26, 2011

Status Verified

January 1, 2011

Enrollment Period

3 months

First QC Date

October 18, 2010

Last Update Submit

January 25, 2011

Conditions

Alzheimer´s Disease

Keywords

AD01 follow-up extension

Outcome Measures

Primary Outcomes (1)

  • Long term tolerability and safety of AFFITOPE AD01

    retrospective assessment of safety data

    One year.

Study Arms (1)

AD01with or without adjuvant

Patients who have received at least one immunization of AD01 with or without adjuvant during AFF001

Eligibility Criteria

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

Patients having participated in AFFiRiS 001 and AFF003 and having received ≥1 vaccination with AFFITOPE AD01

You may qualify if:

  • 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 AFF003 and having received ≥1 vaccination with AFFITOPE AD01
  • Availability of a partner/caregiver knowing the patient

You may not qualify if:

  • Patients having received no vaccination with AFFITOPE AD01
  • History of questionable compliance to visit schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ. Klinik für Neurologie

Vienna, 1090, Austria

Location

Study Officials

  • Peter Dal-Bianco, MD

    Univ. Klinik für Neurologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 21, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

January 26, 2011

Record last verified: 2011-01

Locations

AU(1)