"Randomized, controlled, parallel group, patient-blinded, single-center phase I pilot study to assess tolerability and safety of repeated s.c. administration of a single-dose of AFFITOPE AD02 applied with or without adjuvant to patients with mild to moderate Alzheimer’s Disease"
General Information:
The vaccine targets Aβ40-42, which is the main component of the so-called amyloid plaques being typical for Alzheimer’s Disease.
Animal experiments showed that administration of the vaccine leads to a reduction of Aβ-load and the number of amyloid plaques in the brains of APP transgenic mice as well as to an improvement of their cognitive functions.
The primary objective of this clinical trial is to assess safety and tolerability of the vaccine AFFITOPE AD02 in humans. Secondary objectives include the assessment of the treatment effect on the participants’ cognitive function (= clinical efficacy) and analysis of the immune response induced by the treatment (= immunologic efficacy).
Main inclusion criteria:
- Alzheimer’s disease of mild to moderate degree (MMSE of 16 to 26).
- Hachinski Ischemia Scale =4
- Age 50-80 years.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Availability of a partner/caregiver knowing the patient and being able to accompany the patient at the visits and being available for the telephone interviews.
Main exclusion criteria:
- Contraindication for MRI imaging.
- Operation (under general anaesthesia) within 3 months prior to study entry and scheduled elective operation during the whole study period.
- Participation in another clinical trial.
- Prior and/or current treatment with immunosuppressive drugs
- Active infectious disease (e.g., Hepatitis B, C).
- Presence and/or history of Immunodeficiency (e.g., HIV).
About the study
The trial is conducted at a single center in Vienna.
24 patients will be enrolled into the trial.
Each patient’s
participation will last 22 weeks. Patients will receive
4 vaccinations at 4-week-intervals subcutaneously into
the upper arm region.
I consider participation in this study
See also:
I want to receive more
information
http://clinicaltrials.gov/ct2/show/NCT00633841
|
