AD01 Follow up Extension Visit NCT01225809

Updated 06/21/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01225809
Other study ID #	AFF003E
Secondary ID
Status	Completed
Phase	N/A
First received	October 18, 2010
Last updated	January 25, 2011
Start date	September 2010
Est. completion date	January 2011

Study information
Verified date	January 2011
Source	Affiris AG
Contact	n/a
Is FDA regulated	No
Health authority	Austria: Agency for Health and Food Safety
Study type	Observational

Clinical Trial 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.

Recruitment information / eligibility
Status	Completed
Enrollment	17
Est. completion date	January 2011
Est. primary completion date	December 2010
Accepts healthy volunteers	No
Gender	Both
Age group	N/A and older
Eligibility	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 AFF003 and having received =1 vaccination with AFFITOPE AD01 - Availability of a partner/caregiver knowing the patient Exclusion Criteria: - Patients having received no vaccination with AFFITOPE AD01 - History of questionable compliance to visit schedule

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country	Name	City	State
Austria	Univ. Klinik für Neurologie	Wien

Sponsors *(1)*
Lead Sponsor	Collaborator
Affiris AG

Country where clinical trial is conducted

Austria,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Long term tolerability and safety of AFFITOPE AD01	retrospective assessment of safety data	One year.	Yes

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