CompletedPhase 1

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

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

Lead sponsor

Affiris AG

Asset

AFFITOPE AD02

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 50-85•MRI contraindications excluded

Primary endpoint

•Safety and Tolerability

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAFF004A

NCT IDNCT01093664

Timeline

Milestones

Study start2009-10 (month precision)

Study first posted2010-03-26estimated

Primary completion2010-07actual (month precision)

Study completion2010-07actual (month precision)

Last update posted2010-10-19estimated

Assets

Drug assets

AFFITOPE AD02

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Neuroimaging

Caregiver / quality of life

Neuroimaging

1 endpoint

Primary/protocol endpoint

Safety and Tolerability

Time frame:July 2010

event count, event

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

Immunological and clinical activity

Time frame:July 2010

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.