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

Terminated

• Conditions: Alzheimer's Disease

• Registration Number: NCT01568086
• Lead Sponsor: Affiris AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2012-03-29
• Study First Posted: 2012-04-02
• Primary Completion: 2013-06
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety/Tolerability	52 weeks	* 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)

Secondary Outcome Measures

Name	Time	Method
Immunological	52 weeks	- Titre of antibodies specific for the immunizing peptide, N-terminal part of Aβ, Aβ itself, N-terminally truncated and Pyroglutamate-modified versions of Aβ, and KLH by ELlSA
Clinical Efficacy	52 weeks	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

Trial Locations

Locations (2)

Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt; 🇦🇹 Vienna, Austria

Medical University of Vienna, Department for Psychiatry and Psychotherapy; 🇦🇹 Wien, Austria