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

A

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)

20 participants in 1 patient group

AFFITOPE AD02
Experimental group
Treatment:
Biological: AFFITOPE AD02

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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