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Completed

NCT Number: NCT01093664

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ordination Schmitz

Vienna, State of Vienna, 1010, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AFFITOPE AD02

Biological

s.c. injection

Primary outcomes

  1. 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

  1. Immunological and clinical activity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Affiris AG

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 26, 2010
Registry last updated
Oct 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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