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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Affiris AG
ClinicalTrials.gov Identifier:
NCT01568086
First received: December 16, 2011
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Alzheimer's Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Affiris AG:

Primary Outcome Measures:
  • Safety/Tolerability [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    • 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:
  • Clinical Efficacy [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    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

  • Immunological [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    - 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

Serum


Estimated Enrollment: 24
Study Start Date: December 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
AFFITOPE AD03 with adjuvant
AFFITOPE AD03 without adjuvant

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568086

Locations
Austria
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
Investigators
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
  More Information

No publications provided

Responsible Party: Affiris AG
ClinicalTrials.gov Identifier: NCT01568086     History of Changes
Other Study ID Numbers: AFF005B
Study First Received: December 16, 2011
Last Updated: March 29, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013