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

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Biological: AFFITOPE AD02

• Registration Number: NCT01093664
• Lead Sponsor: Affiris AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-02
• Study Start: 2009-10
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-18
• Last Update Posted: 2010-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AFFITOPE AD02	AFFITOPE AD02	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	July 2010	* 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)

Secondary Outcome Measures

Name	Time	Method
Immunological and clinical activity	July 2010	Immunological parameters: - Assessment of the immune response triggered by the vaccine (titre of IgG antibodies specific for the immunizing peptide, N-terminal part of Aβ, (irrelevant peptide serves as specificity control), Aβ itself and KLH as assessed by ELlSA as well as the results of the biacore affinity measurements towards the immunizing peptide and Aβ); 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

Trial Locations

Locations (1)

Ordination Schmitz; 🇦🇹 Vienna, Austria