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

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Biological: AFFITOPE AD02

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1010
    • Ordination Schmitz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AFFITOPE AD02	Biological: AFFITOPE AD02; s.c. injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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	July 2010

Collaborators and Investigators

• Sponsor: Affiris AG
• Investigators: Principal Investigator: Margot Schmitz, Univ. Doz., Ordination Schmitz

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: September 2, 2009
• First Submitted That Met QC Criteria: March 25, 2010
• First Posted (ESTIMATE): March 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 19, 2010
• Last Update Submitted That Met QC Criteria: October 18, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: AFF004A