CompletedPhase 1

Tolerability and Safety of Subcutaneous Administration of AFFITOPE AD02 in Mild to Moderate Alzheimer's Disease

Randomized, Controlled, Parallel Group, Patient-Blinded, Single-Center Phase I Pilot Study to Assess Tolerability and Safety of Repeated s.c. Administration of a Single-Dose of AFFITOPE AD02 Applied With or Without Adjuvant to Patients With Mild to Moderate Alzheimer's Disease

Lead sponsor

Affiris AG

Asset

AFFITOPE AD02

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 16-26•MRI contraindications excluded

Primary endpoint

•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 IDAffiris 002

NCT IDNCT00633841

Timeline

Milestones

Study start2008-02 (month precision)

Study first posted2008-03-12estimated

Primary completion2009-09actual (month precision)

Study completion2009-09actual (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 age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Main Inclusion Criteria:

•Diagnosis of probable Alzheimer's disease based on the NINCDS/ADRDA criteria.

•Alzheimer's disease of mild to moderate degree (MMSE 16-26)

•Magnetic Resonance Imaging scan (MRI) of brain consistent with diagnosis of AD.

•Written informed consent signed and dated by the patient and the caregiver.

•Age 50-80 years.

•Availability of a partner/caregiver

Other Inclusion Criteria apply

Exclusion criteria

•Presence or history of allergy to components of the vaccine.

•Contraindication for MRI imaging.

•Participation in another clinical trial.

•Prior and/or current treatment with experimental immunotherapeutics including IVIG or vaccines for AD.

•Prior and/or current treatment with immunosuppressive drugs

•History and/or presence of autoimmune disease.

Other Exclusion Criteria apply.

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

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Tolerability

Time frame:1 year

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Immunological and clinical efficacy (evaluated in explorative manner)

Time frame:1 year

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.