CompletedPhase 1

Tolerability and Safety of Subcutaneous Administration of Affitope AD01 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 AD01 Applied With or Without Adjuvant to Patients With Mild to Moderate Alzheimer's Disease

Lead sponsor

Affiris AG

Asset

AFFITOPE AD01

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•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 001

SecondaryEUDRACT Number 2006-007063-90

NCT IDNCT00495417

Timeline

Milestones

Study start2007-07 (month precision)

Study first posted2007-07-03estimated

Primary completion2009-08actual (month precision)

Study completion2009-08actual (month precision)

Last update posted2010-10-19estimated

Assets

Drug assets

AFFITOPE AD01

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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

•Assessing the severity of Alzheimer's disease of mild to moderate degree by the Mini Mental State Examination (MMSE 16-26)

•Hachinski Ischemia Scale ≤ 4.

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

•Informed consent capability (as determined by an independent neurologist)

•Written informed consent signed and dated by the patient or the patient's legal representative and the caregiver.

•Age >50 years.

•Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits and being available for the telephone interviews.

•Adequate visual and auditory acuity to allow neuropsychological testing.

•Female patients of childbearing potential using a medically accepted contraceptive method.

•AD therapies on stable doses for at least 3 months prior to Visit 1 and during the entire trial period.

•Stable doses of all other medications for at least 30 days prior to Visit 1 if considered relevant by the investigator

Exclusion criteria

•Pregnant women.

•Sexually active women of childbearing potential not using a medically accepted birth control method.

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

•Contraindication for MRI imaging.

•Operation (under general anaesthesia) within 3 months prior to study entry and scheduled elective operation during the whole study period.

•Participation in another clinical trial.

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

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

•Prior and/or current treatment with immunosuppressive drugs, concurrent treatment with beta-blockers.

•History and/or presence of autoimmune disease.

•Recent (≤3 years since last specific treatment) history of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia).

•Major psychiatric disorder (e.g. schizophrenia), if considered relevant by the investigator.

•Active infectious disease (e.g., Hepatitis B, C).

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

•Significant neurological disease other than AD.

•Significant systemic illness.

•History of stroke or seizure.

•Change in dose of standard treatments for AD within 3 months prior to visit 1.

•Change in dose of other previous and current medications within the last 30 days prior to visit 1, if considered relevant by the investigator.

•Alcoholism or substance abuse within the past year (alcohol or drug intoxication).

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:One year

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Immunological and clinical efficacy (evaluated in explorative manner)

Time frame:One 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.