Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02

Affiris

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Biological: AFFITOPE AD02

Study type: Interventional

Funder types: Industry

Identifiers

NCT01093664

AFF004A

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participation in AFF002 and AFF004

Exclusion criteria

• Presence or history of allergy to components of the vaccine, if considered relevant by the investigator
• Contraindication for MRI imaging
• History and/or presence of autoimmune disease, if considered relevant by the investigator
• Active infectious disease (e.g., Hepatitis B, C)
• Presence and/or history of Immunodeficiency (e.g., HIV)
• Significant systemic illness

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

AFFITOPE AD02

Experimental group

Treatment:

Biological: AFFITOPE AD02