| „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
AD01 applied with or without adjuvant to patients with
mild to moderate Alzheimer’s Disease”
General Information:
The vaccine targets Aß40-42, 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 Aß-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 AD01 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 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, concurrent treatment with ß-blockers.
- 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:
http://www.clinicaltrials.gov/ct/show/NCT00495417?order=1
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