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

Affiris AG2 sites in 1 country16 target enrollmentDecember 2011

ConditionsAlzheimer's Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: Affiris AG
Enrollment: 16
Locations: 2
Primary Endpoint: Safety/Tolerability
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

October 2013

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Affiris AG

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Safety/Tolerability

Time Frame: 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)