Long-term Safety and Tolerability of AFFITOPE AD01

Affiris AG22 enrolled

Overview

The purpose of this study is to assess the long-term tolerability and -safety of AFFITOPE AD01 applied during AFFiRiS 001

Study Type

OBSERVATIONAL

Enrollment

Conditions

Alzheimer's Disease

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent signed and dated by the patient or the patient's legal representative and the caregiver * Patients having participated in AFFiRiS 001 and received at least 1 vaccination with AFFITOPE AD01 * Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits. Exclusion Criteria: * Patients having received no vaccination with AFFITOPE AD01 * Contraindication for MRI imaging * History of questionable compliance to visit schedule, patients not expected to complete the clinical trial

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Outcomes

Primary Outcomes

Tolerability

Time frame: 1 year

Secondary Outcomes

Immunological and clinical efficacy (evaluated in an explorative manner only)

Time frame: 1 year

Data from ClinicalTrials.gov

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