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TerminatedPhase 2

Follow-up Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in AFF006

A Randomized, Controlled, Parallel Group, Double-blind, Multi-centre, Phase IIb Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in the AFFITOPE® AD02 Phase II Study AFF006.

Lead sponsor

Affiris AG

Asset

AFFITOPE AD02

Listed sites

Recruiting sites

Enrollment

194

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 50-85•MRI contraindications excluded

Primary endpoint

•ADAS-Cog

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

Eudract number2012-005280-27

Org study IDAFF006A

NCT IDNCT02008513

Timeline

Milestones

Study start2013-06 (month precision)

Study first posted2013-12-11estimated

Primary completion2014-09actual (month precision)

Study completion2014-09actual (month precision)

Last update posted2015-06-24estimated

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

•patients having participated in AFF006+having received 6 investigational medicinal product (IMP) injections+having completed all visits

•Written informed consent

•Availability of a partner/caregiver

•Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.

•Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial

Exclusion criteria

•Pregnant women.

•Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects.

•Participation in the active treatment phase of another clinical trial except AFF006 within 3 months before Visit 0.

•History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.

•Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.

•Contraindication for MRI imaging

•Presence and/or history of immunodeficiency (e.g., HIV infection).

•Prior and/or current treatment with experimental immunotherapeutics including Intravenous immunoglobulin (IVIG), AD antibody therapy and/or vaccines for AD except AD02.

•Prior and/or current treatment with immunosuppressive drugs.

•Treatment with benzodiazepines and/or nootropics administered at high doses and/or as newly started treatment.

•Treatment with anticholinergic drugs including Parkinson treatments, antidepressants (tricyclics), neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases.

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.

Global cognition

2 endpoints

Primary/protocol endpoint

Composite Measures of Primary Safety and Tolerability Endpoints

Time frame:19 months

ADAS-Cog

event count, event

Secondary/protocol endpoint

Composite Measures of Secondary Efficacy Endpoints

Time frame:19 months

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

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.