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Follow-up Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in AFF006

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ClinicalTrials.gov Identifier: NCT02008513
Recruitment Status : Terminated (Study AFF006A was early terminated by the sponsor based on the results of study AFF006.)
First Posted : December 11, 2013
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Affiris AG

October 30, 2013
December 11, 2013
June 24, 2015
June 2013
September 2014   (Final data collection date for primary outcome measure)
Composite Measures of Primary Safety and Tolerability Endpoints [ Time Frame: 19 months ]
  • Withdrawal criteria
  • Number of Adverse events (AEs)
  • Number of any serious adverse events (SAE)
  • Alzheimer's Disease Assessment Scale - Cognition (ADAScog)
  • Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL)
Same as current
Complete list of historical versions of study NCT02008513 on ClinicalTrials.gov Archive Site
Composite Measures of Secondary Efficacy Endpoints [ Time Frame: 19 months ]
  • Clinical Dementia Rating Sum of Boxes (CDR-sb)
  • Free and Cued Selective Reminding Test (FCSRT)
  • Standard neuropsychological test battery (CogState)
  • Mini-Mental State Examination (MMSE)
  • Investigator's global evaluation scale (IGE)
  • CDR [global aspects]
  • Neuropsychiatric Inventory (NPI) [behavior]
  • quality of life (QOL) -AD
Same as current
Not Provided
Not Provided
 
Follow-up Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in AFF006
A Randomized, Controlled, Parallel Group, Double-blind, Multi-centre, Phase IIb Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in the AFFITOPE® AD02 Phase II Study AFF006.
This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer´s Disease
  • Biological: AFFITOPE® AD02
  • Biological: Placebo
  • Active Comparator: Group 1
    AFF006 Placebo groups receive 6 AFFITOPE® AD02 vaccinations
    Intervention: Biological: AFFITOPE® AD02
  • Active Comparator: Group 2
    AFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations
    Interventions:
    • Biological: AFFITOPE® AD02
    • Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
194
250
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients having participated in AFF006+having received 6 investigational medicinal product (IMP) injections+having completed all visits
  • Written informed consent
  • Availability of a partner/caregiver
  • Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.
  • Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial.

Exclusion Criteria:

  • Pregnant women.
  • Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects.
  • Participation in the active treatment phase of another clinical trial except AFF006 within 3 months before Visit 0.
  • History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
  • Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.
  • Contraindication for MRI imaging
  • Presence and/or history of immunodeficiency (e.g., HIV infection).
  • Prior and/or current treatment with experimental immunotherapeutics including Intravenous immunoglobulin (IVIG), AD antibody therapy and/or vaccines for AD except AD02.
  • Prior and/or current treatment with immunosuppressive drugs.
  • Treatment with benzodiazepines and/or nootropics administered at high doses and/or as newly started treatment.
  • Treatment with anticholinergic drugs including Parkinson treatments, antidepressants (tricyclics), neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases.
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Croatia,   Czech Republic,   France,   Germany,   Slovakia
 
 
NCT02008513
AFF006A
2012-005280-27 ( EudraCT Number )
Yes
Not Provided
Not Provided
Affiris AG
Affiris AG
Not Provided
Principal Investigator: Bruno Dubois, Prof. Centre des Maladies Cognitives et Comportementales, Federation des maladies du systeme nerveux, Hoptial de la Salpetriere, Pavillon Paul Castaignes (Sous-sol), 47-83 Bd de l'Hopital, 75651 Paris Cedex 13
Affiris AG
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP