CompletedPhase 2

Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease

A Randomized, Controlled, Parallel Group, Double-blind, Multi-center, Phase II Study to Assess the Clinical- and Immunological Activity,as Well as the Safety and Tolerability of Different Doses/Formulations of AFFITOPE AD02 Administered Repeatedly to Patients With Early Alzheimer's Disease

Lead sponsor

Affiris AG

Asset

AFFITOPE AD02

Listed sites

Recruiting sites

Enrollment

335

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 20•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 number2009-016504-22

Org study IDAFF006

NCT IDNCT01117818

Timeline

Milestones

Study first posted2010-05-06estimated

Study start2010-09 (month precision)

Primary completion2013-12actual (month precision)

Study completion2013-12actual (month precision)

Last update posted2013-12-11estimated

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

•Informed consent capability

•Early AD, based on episodic memory deficit and hippocampal atrophy

•Age from 50 to 80, inclusive

•MMSE of 20+

•Brain magnetic resonance imaging scan consistent with the diagnosis of AD

•Stable doses of medications (cholinesterase inhibitors and memantine allowed)

•Caregiver able to attend all visits with patient

Exclusion criteria

•Significant neurological disease other than AD

•Major psychiatric illness

•Significant systemic illness

•Autoimmune disease

•Prior treatment with experimental immunotherapeutics for AD including IVIG

•Women of childbearing potential without birth control

•Contraindication for MRI scan

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

cognitive(ADAS-cog modified) and functional(ADCS-ADL modified)

Time frame:18 months

ADAS-Cog

descriptive

Secondary/protocol endpoint

cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI)

Time frame:18 months

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

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Haaland B, Dickson SP, Santana AF, Tanzi RE, Dubois B, Peters O, Grimmer T, Christensen J, Mallinckrodt C, Schneeberger A, Hendrix SB. Efficacy of AD04, an aluminum-based vaccine adjuvant, in patients with early Alzheimer's disease: Post hoc analysis of AFF006 (NCT01117818), a proof-of-concept, phase 2 randomized controlled trial. J Alzheimers Dis. 2025 Nov;108(1):234-242. doi: 10.1177/13872877251375985. Epub 2025 Sep 15.
PMID40953123via DERIVED

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.