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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01568086
Recruitment Status : Terminated (The study could not be performed as planned for organizational reasons.)
First Posted : April 2, 2012
Last Update Posted : November 6, 2013
Information provided by (Responsible Party):
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.

Condition or disease
Alzheimer's Disease

Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD03 Applied During AFFiRiS 005A
Study Start Date : December 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

AFFITOPE AD03 with adjuvant
AFFITOPE AD03 without adjuvant

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Clinical Efficacy [ Time Frame: 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

  2. Immunological [ Time Frame: 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

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with mild to moderate Alzheimer's disease (MMSE 16 to 26)that have participated in AFF005A

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01568086

Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt
Vienna, Austria, 1080
Medical University of Vienna, Department for Psychiatry and Psychotherapy
Wien, Austria, 1090
Sponsors and Collaborators
Affiris AG
Principal Investigator: Siegfried Kasper, Prof.Dr. Medical University of Vienna ,Department for Psychiatry and Psychotherapy
Principal Investigator: Dieter Volc, Prim. Dr. Studienzentrum der PROSENEX,AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt

Responsible Party: Affiris AG Identifier: NCT01568086     History of Changes
Other Study ID Numbers: AFF005B
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Immunologic Factors
Physiological Effects of Drugs