Safety and Tolerability of AFFITOPE AD03

NCT01309763 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2011-12-20

No results posted yet for this study

Summary

This is a randomized, controlled, parallel group, patient-blinded, single-center, phase I pilot study to assess tolerability and safety of repeated subcutaneous administration of a single-dose of AFFITOPE AD03 applied with or without adjuvant to patients with mild to moderate Alzheimer's disease.

Conditions

Interventions

BIOLOGICAL

AFFITOPE AD03

s.c. injection

BIOLOGICAL

AFFITOPE AD03 + Alum

s.c. injection

Sponsors & Collaborators

  • Affiris AG

    lead INDUSTRY

Principal Investigators

  • Siegfried Kasper, MD · MUW

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-09-30
Completion
2011-11-30

Countries

  • Austria

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01309763 on ClinicalTrials.gov