A Phase 1 interventional study of AFFITOPE AD02 in Alzheimer's Disease, sponsored by Affiris AG. Completed at 1 site in Austria. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-10-19.
Sponsored by Affiris AG · Phase 1, Interventional, and Treatment
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Affiris AG is the lead sponsor of 20 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: AFFITOPE AD02
s.c. injection
Safety and Tolerability
* 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)
Time frame: July 2010
Immunological and clinical activity
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
Time frame: July 2010
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Affiris AG