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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01117818

Enrollment

335

Registered

2010-05-06

Start date

2010-09-30

Completion date

2013-12-31

Last updated

2013-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

This is a multiple vaccination study to find out if it is a safe treatment and what effects it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80 years. Approximately 40 study sites in Europe will be involved. Patients will be randomized to receive either AFFITOPE AD02 or placebo. Each patient's participation will last 1 year.

Detailed description

AFFITOPE AD02 is a second generation AD immunotherapeutics targeting Aβ. Its active component is a synthetic peptide functionally mimicking the unmodified N-terminus of Aβ.

Interventions

BIOLOGICALactive: AFFITOPE AD02

vaccination

BIOLOGICALcontrol: Placebo

vaccination

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
cognitive(ADAS-cog modified) and functional(ADCS-ADL modified)	18 months

Secondary

Measure	Time frame
cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI)	18 months

Countries

Austria, Croatia, Czechia, France, Germany, Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026