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

Alzheimer's Disease Clinical Trial

Official title:

Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD03 Applied During AFFiRiS 005A

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01568086
• Other study ID #: AFF005B
• Status: Terminated
• Phase: N/A
• First received: December 16, 2011
• Last updated: November 5, 2013
• Start date: December 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Affiris AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: October 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Locations

Country	Name	City	State
Austria	Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt	Vienna
Austria	Medical University of Vienna, Department for Psychiatry and Psychotherapy	Wien

Sponsors (1)

Lead Sponsor	Collaborator
Affiris AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/Tolerability	Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal; Number and kind (description) of AEs; Number and kind (description) of SAEs; Changes from study AFF005A in: Physical and neurological examination/ Concomitant medication/ Vital signs (blood pressure, heart rate, respiratory rate, body temperature)/ Body mass (weight)/ MRI of the brain/ ECG/ Laboratory assessment (haematology, biochemistry, coagulation, serology, APP crossreactivity and urinalysis)	52 weeks	Yes
Secondary	Clinical Efficacy	Changes from study AFF005A in: CIBIC plus (Clinician's Interview-Based Impression of Change, + carer interview); ADAScog (Alzheimer Disease Assessment Scale-cognitive); CERAD plus (The Consortium to Establish a Registry for AD); Neuropsychiatric inventory; Activity of daily living; Quality of life in patients with Alzheimer's disease; Investigator's global evaluation scale; MRI brain volumetry	52 weeks	No
Secondary	Immunological	- Titre of antibodies specific for the immunizing peptide, N-terminal part of Aß, Aß itself, N-terminally truncated and Pyroglutamate-modified versions of Aß, and KLH by ELlSA	52 weeks	No