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

This study has been terminated.
(The study could not be performed as planned for organizational reasons.)
Sponsor:
Information provided by (Responsible Party):
Affiris AG
ClinicalTrials.gov Identifier:
NCT01568086
First received: December 16, 2011
Last updated: November 5, 2013
Last verified: November 2013
  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:


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


Enrollment: 16
Study Start Date: December 2011
Study Completion Date: October 2013
Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 5, 2013
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 October 16, 2014