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Clinical Trials/NCT01093664
NCT01093664CompletedPhase 1

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

Affiris AG2 sites in 1 country20 target enrollmentStarted: October 2009Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Affiris AG
Enrollment
20
Locations
2
Primary Endpoint
Safety and Tolerability
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Safety and Tolerability

Time Frame: 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 Outcomes

  • Immunological and clinical activity(July 2010)

Investigators

Sponsor
Affiris AG
Sponsor Class
Industry

Study Sites (2)

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