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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093664
• Other study ID #: AFF004A
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2009
• Last updated: October 18, 2010
• Start date: October 2009
• Est. completion date: July 2010

Study information

• Verified date: October 2010
• Source: Affiris AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• AFFITOPE AD02
s.c. injection

Locations

Country	Name	City	State
Austria	Ordination Schmitz	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Affiris AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal; Adverse events (AEs); Serious adverse events (SAEs); Physical and neurological examination; Concomitant medication; Vital signs (blood pressure, heart rate, respiratory rate, body temperature); Body mass (weight and height); MRI of brain; ECG; Laboratory assessment (haematology, biochemistry, coagulation, serology and urinalysis)	July 2010	Yes
Secondary	Immunological and clinical activity	Immunological parameters: - Assessment of the immune response triggered by the vaccine (titre of IgG antibodies specific for the immunizing peptide, N-terminal part of Aß, (irrelevant peptide serves as specificity control), Aß itself and KLH as assessed by ELlSA as well as the results of the biacore affinity measurements towards the immunizing peptide and Aß); Clinical efficacy variables: Cognitive and functional tests, behavioural scales; Measurement of quality of life in patients with Alzheimer's disease; Investigator's global evaluation scale	July 2010	No